tag:blogger.com,1999:blog-69732372695771097102024-03-05T09:13:45.110-08:00Lung DiseasesAsthma,Tuberculosis,Cystic Fibrosis, Non-Small Cell Lung Cancer,Respiratory Tract, Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, Status Asthmaticus,Respiratory Syncytial Virus(RSV), Portable Oxygen Concentrator, Home Liquid Oxygen, Emphysema, Pulmonary Arterial Hypertension (PAH)...Unknownnoreply@blogger.comBlogger532125tag:blogger.com,1999:blog-6973237269577109710.post-73505266419735929942024-02-13T02:48:00.000-08:002024-02-13T02:48:55.310-08:00Sionna Therapeutics Announces Phase 1 Initiation for SION-109 in Cystic Fibrosis<p style="text-align: center;"><i>– SION-109 is a small molecule targeting the interface between the ICL4 region and the NBD1 domain of the CFTR protein; designed to complement the company’s NBD1 modulator portfolio –</i></p><p style="text-align: center;"><i><br /></i></p><p style="text-align: center;"><i>– First subject dosed in Phase 1 clinical trial –</i></p><p style="text-align: center;"><br /></p><p><i>Boston, MA, January 24, 2024</i> — <a href="https://www.sionnatx.com/" rel="nofollow" target="_blank">Sionna Therapeutics</a>, a life sciences company dedicated to developing highly effective and differentiated treatments for cystic fibrosis (CF), announced that the first healthy subject has been dosed in a Phase 1 clinical trial of SION-109 following clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA).</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi67TibEE61I9OFcBavqvSw3Xy2kD9K5ycFSJKzH0Ygz9LxqUUi29gUxMZsP2Myg4HW9k2PlptmuccdN1eUqmIBHm_O1GY4wIhQDPCCIkZJRkKZC5qnQHQQ2rP8qR_U968DYC4n5SeiPl0dwOyyGKaudIoowRsldOe84VLuq9a-S79VcMTeWxWTGXRdyY_W/s168/Sionna%20Therapeutics%202024.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="Sionna Therapeutics" border="0" data-original-height="60" data-original-width="168" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi67TibEE61I9OFcBavqvSw3Xy2kD9K5ycFSJKzH0Ygz9LxqUUi29gUxMZsP2Myg4HW9k2PlptmuccdN1eUqmIBHm_O1GY4wIhQDPCCIkZJRkKZC5qnQHQQ2rP8qR_U968DYC4n5SeiPl0dwOyyGKaudIoowRsldOe84VLuq9a-S79VcMTeWxWTGXRdyY_W/s16000/Sionna%20Therapeutics%202024.PNG" /></a></div><br /><p style="text-align: left;">SION-109 is a small molecule designed to target the interface between the intracellular loop 4 (ICL4) region and the first nucleotide-binding domain (NBD1) of the cystic fibrosis transmembrane conductance regulator (CFTR) protein. It is a complementary mechanism to the company’s portfolio of compounds directly targeting NBD1, including SION-638, the first-in-class NBD1 stabilizer now in Phase 1.</p><p><br /></p><p>“Our ability to target NBD1 correction is truly novel, and with SION-109 now entering clinical development, we have the opportunity to develop proprietary combination treatments that have the potential to achieve full CFTR correction,” said Mike Cloonan, President and Chief Executive Officer of Sionna. “Advancing our second investigational drug into Phase 1 is an achievement made possible by the tireless work of our research and development teams, who have deep experience in CF and a sharp focus on advancing these programs rapidly to deliver new options for people living with CF and their families.”</p><p><br /></p><p>CF is caused by genetic mutations in the CFTR protein, an epithelial ion channel that is essential for producing healthy, freely flowing mucus in the airways, digestive system, and other organs. The most common mutation in CFTR, ΔF508, causes NBD1 to unfold at body temperature and severely impairs CFTR function. Complementary targets including ICL4 may enable combination treatments with the potential for full CFTR correction. It is estimated that 90 percent of people living with CF have the genetic mutation ΔF508... <i><span style="font-size: x-small;"><a href="https://www.sionnatx.com/press-releases/sionna-therapeutics-announces-phase-1-initiation-for-sion-109-in-cystic-fibrosis/" rel="nofollow" target="_blank">Sionna Therapeutics' Press Release</a></span></i> - </p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-86378252380104117402024-02-07T02:15:00.000-08:002024-02-07T02:15:25.914-08:00NuvoAir’s Air Next Spirometer is FDA-approved for in-home use<p><b>The Air Next Spirometer was granted 510k approval for in-home use by the NuvoAir clinical team and its clinical trials partners.</b></p><p><i>January 25th, 2024 – Boston, MA</i>: <a href="https://www.nuvoair.com/" rel="nofollow" target="_blank">NuvoAir Medical</a> announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir to scale and expand clinical operations to ensure no patient with heart or lung conditions is left behind.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj5XWPr_PpWTzO_SA2zIsiNPY0hdDmZHBibvPpoUj2D34Wig0mMWIDDAmuaPYMAQT9seY7K9NyEO5Ii1y5xSVJoprvZFPTf1e4z-OUp7q-gigPujjaIGShUSBZDsn5TrvM6aqd9ZJXOasA20kgW5LH9gpkqNyzNnpXWWS6zHJ3yUv0rQoczFPNYljkNPloF/s283/nuvoair%20medical%202024.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="NuvoAir Medical" border="0" data-original-height="51" data-original-width="283" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj5XWPr_PpWTzO_SA2zIsiNPY0hdDmZHBibvPpoUj2D34Wig0mMWIDDAmuaPYMAQT9seY7K9NyEO5Ii1y5xSVJoprvZFPTf1e4z-OUp7q-gigPujjaIGShUSBZDsn5TrvM6aqd9ZJXOasA20kgW5LH9gpkqNyzNnpXWWS6zHJ3yUv0rQoczFPNYljkNPloF/s16000/nuvoair%20medical%202024.PNG" /></a></div><br /><p style="text-align: left;">510(k) clearance allows Air Next to conduct full spirometry at home, providing extremely valuable clinical data that ensures patients can be monitored continuously. High-quality lung data empowers the NuvoAir clinical team to intervene when changes are detected and provide instantaneous care before lung function deteriorates to the point where hospitalizations are necessary. For patients with conditions like COPD, Asthma, or ALS, using this easy-to-use device at home means they don’t have to wait for an in-person appointment or plan the logistics for travel.</p><p><br /></p><p>“Air Next is capable of providing our care team with high-quality lung measurements from the comfort of our patients’ homes,” says Eric Harker, MD MPH MBA, and Chief Medical Officer at NuvoAir. “Spirometry has traditionally been underutilized as a diagnostic and monitoring tool because of the logistical challenges of getting complex patients to a clinic with regularity. In-home spirometry empowers our practice to provide continuous care to our patients in the home with real-time, high-quality, and actionable clinical data.”</p><p><br /></p><p>By achieving 510(k) clearance, the Air Next Spirometer can now be used for ATS 2019-compliant spirometry in clinical trials across the US and Europe. “Air Next brings the reliability of in-clinic spirometry right to our patients’ hands,” says Furat Shawki, General Manager of Clinical Trials at NuvoAir. “With in-home approval of ATS 2019-compliant spirometry, we can look forward to scaling our services with our partners across the healthcare ecosystem, including healthcare providers and clinical trials, so we can deliver the cardiopulmonary care that people desperately deserve to the places that need it most.”... <i><span style="font-size: x-small;"><a href="https://www.nuvoair.com/blog/nuvoair-air-next-spirometer-510k-FDA-approved" rel="nofollow" target="_blank">NuvoAir Medical's Press Release</a></span></i> - </p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-10676511192989056732024-01-24T08:53:00.000-08:002024-01-24T08:53:15.287-08:00Thirona : LungQ 3.0.0 receives FDA 510(k) clearance<p><i>Nijmegen, the Netherlands (January 22nd, 2024)</i> – <b>Thirona, a global company specializing in advanced analysis of thoracic CT images with artificial intelligence, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest update of its AI-based clinical software LungQ™ (v3.0.0), making its new features widely available for use in hospitals in the United States.</b></p><p><b><br /></b></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4OZVZ3JmNqWJFMhp4lvWPI5kJGOaX__4feD201YTRuAU90mtbSWvn1j6hxe9nd2E7tXEOsDx0aMEWoHue7GCiSNKDtXz76227grm6G3Cg_hbgQ1irQvvYBD76eaXV7OMaVhqSyV7ppaIPj4_c_nipUSd0a72JfLtAVoyaZA1Ou8qZXOxH_p88sjrtnEV4/s242/Thirona%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Thirona" border="0" data-original-height="69" data-original-width="242" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj4OZVZ3JmNqWJFMhp4lvWPI5kJGOaX__4feD201YTRuAU90mtbSWvn1j6hxe9nd2E7tXEOsDx0aMEWoHue7GCiSNKDtXz76227grm6G3Cg_hbgQ1irQvvYBD76eaXV7OMaVhqSyV7ppaIPj4_c_nipUSd0a72JfLtAVoyaZA1Ou8qZXOxH_p88sjrtnEV4/s16000/Thirona%202024.PNG" /></a></div><p style="text-align: left;"><br /></p><p style="text-align: left;">LungQ 3.0.0 builds on 10 years of clinical trials and 200+ publications to deliver advanced segmentation of pulmonary segments and subsegments.</p><p><br /></p><p>LungQ 3.0.0 is one of the only FDA-cleared solutions that is capable of using AI to automatically segment the pulmonary segments and subsegments found in the internal anatomy of the lung. Based on this analysis, which includes the identification of structures such as lobes, segments, subsegments, airways, and fissures, the technology performs an analysis of the lung tissue and the fissure completeness, supporting physicians in the diagnosis and documentation of pulmonary tissue images from CT thoracic datasets for each individual patient.</p><p><br /></p><p>“A clearer understanding of lung anatomy helps enable broader adoption of minimally invasive treatments for lung diseases such as COPD and lung cancer, helping save more healthy lung tissue and lung function capacity. Acting as a map for lung anatomy, LungQ helps guide bronchoscopic navigation, leveraging AI to significantly enhance the precision, accuracy, and efficiency of bronchoscopic and surgical lung interventions,” said Eva van Rikxoort, Founder and CEO of Thirona. “Solutions like LungQ are helping usher in a new era of personalized treatment for lung patients, enabling clinicians all over the world to conduct more advanced, easier-to-perform and less invasive procedures with full confidence.”</p><p><br /></p><p>The LungQ software first received 510(k) clearance for version 1.1.0 in 2018. With new enhancements, based on deep-learning technology, v.3.0.0 helps guide pulmonologists through the best approach to access various and most peripheral locations within the lungs by delineating pulmonary structures and providing highly accurate reproducible CT values for pulmonary tissue. These insights provide essential, non-invasive quantitative support for diagnosis, treatment planning and follow up examination of lung patients</p><p><br /></p><p>Rita Priori, CTO at Thirona: “Our AI-based image analysis software LungQ is already used by interventional pulmonologist in Europe and Australia, aiding clinicians through procedures like bronchoscopic lung volume reduction and other interventions. We’re excited to build on the value we’re already seeing in the clinic, helping accelerate innovation in and adoption of a multitude of pulmonary interventions that require high precision on a subsegmental and segmental level, such as lung cancer biopsies, surgical lung volume reduction, lung segmentectomy, ablation procedures, and more.”</p><p><br /></p><p>The LungQ AI-powered software is approved for clinical use in Europe, the UK and Australia. It is currently used by more than 600 hospitals and has been validated in more than 200 publications globally. The FDA 510(k) cleared LungQ opens tremendous new opportunities for planning and performing localized treatments with maximum precision and accuracy... <a href="https://thirona.eu/lungq-3-0-0-receives-fda-510k-clearance/" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Thirona's Press Release</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-59724062160328597402024-01-16T06:37:00.000-08:002024-01-16T06:38:23.646-08:00 Affimed Provides Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer<ul style="text-align: left;"><li>Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohort</li><li>Follow-up shows three of the initially reported responses have now been confirmed (1 CR, 2 PR) and one still awaiting a confirmatory scan</li><li>Study to be expanded to a total of 40 EGFRwt NSCLC patients</li><li>Enrollment in the EGFR-mutant (mut) NSCLC cohort is ongoing</li><li>Data from both the EGFRwt and EGFRmut cohorts expected in H1 2024</li></ul><p></p><p><i>MANNHEIM, Germany, Jan. 08, 2024</i> — <a href="https://www.affimed.com/" rel="nofollow" target="_blank">Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”)</a>, a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today provided an update on the clinical response data for the ongoing AFM24-102 phase 1/2a study in EGFRwt NSCLC.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh4j1N1DWN4XlbXAsn5Cuqp-9l7HSCT5FU0uDJYe5bGBh57xFCKgfd7ZBdyyqFSg0x6nd4Lu_BK5BSAm42iyhfBUzUJUQTPbGf3aRpacOk4tc3BA0ho48a0gDCFfxa6y9zt9rYBhWvOkV9TiNwoBP3-pRbnENNIglndNO8UoXcOqh9HETW3Q0EHnlAEIzUv/s331/affimed%202024.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="79" data-original-width="331" height="76" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh4j1N1DWN4XlbXAsn5Cuqp-9l7HSCT5FU0uDJYe5bGBh57xFCKgfd7ZBdyyqFSg0x6nd4Lu_BK5BSAm42iyhfBUzUJUQTPbGf3aRpacOk4tc3BA0ho48a0gDCFfxa6y9zt9rYBhWvOkV9TiNwoBP3-pRbnENNIglndNO8UoXcOqh9HETW3Q0EHnlAEIzUv/s320/affimed%202024.PNG" width="320" /></a></div><p style="text-align: left;"><br /></p><p style="text-align: left;">As of January 4, 2024, updated information on the 4 responses in the 15 patients treated in the EGFRwt NSCLC cohort, now show 1 confirmed complete response (CR), 2 confirmed partial responses (PR) and 1 unconfirmed PR awaiting confirmation. Initial data as presented on December 11, 2023, showed 1 confirmed PR as well as 1 unconfirmed CR, and 2 unconfirmed PRs. The patients enrolled in the Phase 1/2a AFM24-102 in the EGFRwt NSCLC cohort of the trial previously had a median of 2 prior lines of therapy, were heavily pretreated, and all patients had progressed on PD-[L]1 targeted therapy.</p><p><br /></p><p>Based on the promising response data from the EGFRwt NSCLC cohort, Affimed will expand enrollment to 40 patients. Additionally, the Company reported that enrollment of the EGFRmut NSCLC cohort is ongoing. Data from both cohorts are expected in H1 2024.</p><p><br /></p><p>“We are encouraged by the responses in these patients who had all progressed on PD1 targeting therapy and made the strategic decision to expand this patient cohort,” said Dr. Andreas Harstrick, CMO and interim Chief Executive Officer of Affimed. “There is a significant unmet need for these patients who have exhausted all previous lines of therapy and did not respond to any therapies, including PD-1/PD-L1 treatment. We look forward to sharing more updates in the first half of 2024.”... <a href="https://www.affimed.com/affimed-provides-clinical-response-update-on-afm24-102-trial-in-egfr-wildtype-non-small-cell-lung-cancer/" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Affimed's Press Release</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-44022799002153702642024-01-08T07:31:00.000-08:002024-01-08T07:32:37.556-08:00European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors<p style="text-align: center;"><b>Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity in these patient populations</b></p><p style="text-align: center;"><b>If approved, repotrectinib will offer a potential best-in-class treatment for patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer and a new option for patients with NTRK-positive solid tumors, in the European Union</b></p><p style="text-align: center;"><b><br /></b></p><p><i>PRINCETON, N.J.</i>- <a href="https://www.bms.com/" rel="nofollow" target="_blank">Bristol Myers Squibb (NYSE: BMY)</a> announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positivesolid tumors) and CARE study (pediatric patients with NTRK-positivesolid tumors). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqW3KK7HmWIu4u91Dp3I2rKYZfEr_Nd-RysZ-e5wj2sZFj8MItUKPfxFiXX84wji-hHPzPChfmi_GRsmKpRgkNB3e3PocW2jpF38cC_bcedi3LVbTw7Muwgkst3L2gc1-_2JgGjmcyKqJTLfCf3fXxBb9TEidjnxbZWgxxlkwBuPsiNZDT6RG-oU7Jg6ph/s261/Bristol%20Myers%20Squibb%202024.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="Bristol Myers Squibb" border="0" data-original-height="55" data-original-width="261" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhqW3KK7HmWIu4u91Dp3I2rKYZfEr_Nd-RysZ-e5wj2sZFj8MItUKPfxFiXX84wji-hHPzPChfmi_GRsmKpRgkNB3e3PocW2jpF38cC_bcedi3LVbTw7Muwgkst3L2gc1-_2JgGjmcyKqJTLfCf3fXxBb9TEidjnxbZWgxxlkwBuPsiNZDT6RG-oU7Jg6ph/s16000/Bristol%20Myers%20Squibb%202024.PNG" /></a></div><br /><p style="text-align: left;">“While there are existing TKIs for the treatment of ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors, there is still an undeniable need for new options that may offer patients more durable responses, including those with metastatic disease to the brain, and may address the issue of treatment resistance for patients with these aggressive and rare tumors,” said Joseph Fiore, executive director, global program lead, repotrectinib, Bristol Myers Squibb. “The clinical trial results with repotrectinib highlight the potential for this next-generation therapy to become a best-in-class option for patients with tumors harboring ROS1 fusions and a new option for those with NTRK-fusion positive tumors, two groups who each continue to face a high unmet medical need. Today’s validation by the European Medicines Agency brings us another step closer to our goal of making this new targeted therapy available to patients in Europe.”</p><p><br /></p><p>In the TRIDENT-1 and CARE trials, repotrectinib demonstrated clinically meaningful response rates in patients across ROS1-positive NSCLC and NTRK-positive solid tumor cohorts. Durability of response was robust and intracranial responses were observed in both settings, as well as in patients whose tumors harbor common resistance mutations. The safety profile of repotrectinib was well characterized and generally manageable with routine standard-of-care treatments. The study remains ongoing to assess long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive locally advanced or metastatic solid tumors.</p><p><br /></p><p>Additionally, in November 2023 the U.S. Food and Drug Administration approved Augtyro™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.</p><p><br /></p><p>Bristol Myers Squibb thanks the patients and investigators involved with the TRIDENT-1 and CARE clinical trials.</p><p><br /></p><p>Turning Point Therapeutics is a wholly owned subsidiary of the Bristol-Myers Squibb Company. As of August 2022, Bristol Myers Squibb acquired the company, including its asset repotrectinib... <a href="https://news.bms.com/news/corporate-financial/2024/European-Medicines-Agency-Validates-Bristol-Myers-Squibbs-Application-for-Repotrectinib-for-the-Treatment-of-Locally-Advanced-or-Metastatic-ROS1-Positive-Non-Small-Cell-Lung-Cancer-and-NTRK-Positive-Solid-Tumors/default.aspx" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Bristol Myers Squibb’s Press Release</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-52179259756325969472023-12-29T07:11:00.000-08:002023-12-29T07:11:18.715-08:00FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer<p style="text-align: center;"><b>Currently There are no Approved Therapeutic Options for Third-Line Treatment of Advanced SCLC1</b></p><p style="text-align: center;"><b>If Approved, Tarlatamab Would be the First BiTE® Therapy for a Major Solid Tumor</b></p><p style="text-align: center;"><b>FDA Target Action Date is June 12, 2024</b></p><p><i><br /></i></p><p><i>THOUSAND OAKS, Calif., Dec. 13, 2023 </i>/ - <a href="https://www.amgen.com/" rel="nofollow" target="_blank">Amgen (NASDAQ:AMGN)</a> announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXcgzFY9a1h8lJl8rWlyX1VPvuJjC_XL8fTWlY5LQQXZEomFQgvUP-IebDgNv_beIv-AhA-F_8fMTmoUu7TjpevuXnq5V15eN7uTf19Ojs6KFzjkpbEr6kqde9t53Ssa6biRzDPZRfNfi6hafXmX62Oz-gq7e3DVYoaVGbQx3GV5ZZi-AHgxab4T-8iO1Y/s136/amgen%202023.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="AMGEN" border="0" data-original-height="45" data-original-width="136" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgXcgzFY9a1h8lJl8rWlyX1VPvuJjC_XL8fTWlY5LQQXZEomFQgvUP-IebDgNv_beIv-AhA-F_8fMTmoUu7TjpevuXnq5V15eN7uTf19Ojs6KFzjkpbEr6kqde9t53Ssa6biRzDPZRfNfi6hafXmX62Oz-gq7e3DVYoaVGbQx3GV5ZZi-AHgxab4T-8iO1Y/s16000/amgen%202023.PNG" /></a></div><br /><p style="text-align: left;">Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. </p><p><br /></p><p>"The FDA's Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "While first-line treatments often show strong responses, patients can experience aggressive recurrences and long-term survival remains a challenge.2,3 Unfortunately, for patients who relapse, there are limited treatment options, emphasizing the importance of bringing new therapies to this patient population with advanced disease."</p><p><br /></p><p>The FDA grants Priority Review to applications for medicines that offer, if approved, significant improvements over available options or may provide a treatment option where no adequate therapy currently exists. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for tarlatamab is June 12, 2024.</p><p><br /></p><p>The BLA is based on the Phase 2 results from the DeLLphi-301 clinical trial that studied patients with advanced SCLC with disease progression on or after platinum-based chemotherapy. Results from the study were recently featured as part of a late-breaking presentation during the 2023 <a href="https://www.esmo.org/" rel="nofollow" target="_blank">European Society for Medical Oncology (ESMO)</a> Congress and simultaneously <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2307980" rel="nofollow" target="_blank">published in the New England Journal of Medicine</a>.4,5 The data presented demonstrated antitumor activity with a durable response and encouraging survival outcomes in previously treated SCLC. The safety profile was consistent with the Phase 1 trial.6</p><p><br /></p><p>Tarlatamab is being investigated in multiple studies including DeLLphi-302, a Phase 1b study evaluating tarlatamab in combination with an anti-PD-1 therapy in second-line or later SCLC; DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard of care therapies in first-line SCLC; DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab monotherapy with standard of care chemotherapy in second-line treatment of SCLC that is enrolling patients; DeLLphi-306, a recently-initiated, randomized Phase 3 trial of tarlatamab following chemoradiotherapy in earlier settings of SCLC; and DeLLpro-300, a Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.7 Amgen also plans to initiate an additional Phase 3 study of tarlatamab in first-line treatment of SCLC.</p><p><br /></p><p>In October, tarlatamab was granted Breakthrough Therapy Designation by the FDA. The application is being reviewed by the FDA under the Project Orbis framework and Real Time Oncology Review (RTOR). Project Orbis is an initiative from the FDA Oncology Center of Excellence that provides a framework for concurrent submission of oncology products among certain countries...<a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">Amgen's Press Release</span></i></a> - <a href="https://clinicaltrials.gov/study/NCT05060016" rel="nofollow" target="_blank"><i><span style="font-size: x-small;">NCT05060016</span></i></a> -</p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-3096811108245272462023-11-14T00:33:00.000-08:002023-11-14T00:47:19.402-08:00CorVista Health Announces AHA Presentation of Machine Learning to Detect Pulmonary Hypertension at Point-of-Care<p><i>Washington DC—November 12, 2023</i>—<a href="https://www.corvista.com/" rel="nofollow" target="_blank">CorVista Health, Inc,</a> a leading digital health company dedicated to improving cardiovascular disease diagnosis, is pleased to announce the presentation of Machine Learning to Detect Pulmonary Hypertension data at <a href="https://professional.heart.org/en/meetings" rel="nofollow" target="_blank">AHA</a>.</p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhrjjGdc_XMlZqBYaFmKKLb3z_Bhbq8Pr5qPHGdh1zHUFlpDyF4etkmWPy1clAMhg8pxHo0MerBR8D70ZgQhjZ-GvYjE7nq5rM0qhUwz8V69K6AEKJV6uaHyzNwn4tXc1SZHMRh2aFPPHW9FCnqlot7PGYSnG6-41bWMuIFlTCJglwLjKIans4UuWrspeag/s217/corvista%20health%20logo%2014%2011%202023.PNG" style="margin-left: 1em; margin-right: 1em;"><img alt="CorVista Health" border="0" data-original-height="67" data-original-width="217" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhrjjGdc_XMlZqBYaFmKKLb3z_Bhbq8Pr5qPHGdh1zHUFlpDyF4etkmWPy1clAMhg8pxHo0MerBR8D70ZgQhjZ-GvYjE7nq5rM0qhUwz8V69K6AEKJV6uaHyzNwn4tXc1SZHMRh2aFPPHW9FCnqlot7PGYSnG6-41bWMuIFlTCJglwLjKIans4UuWrspeag/s16000/corvista%20health%20logo%2014%2011%202023.PNG" /></a></div><br /><p style="text-align: center;"><br /></p><p>“We are pleased to present this important data at this year’s AHA meeting.” said Don Crawford, President and CEO of CorVista Health. “Pulmonary hypertension is a challenging condition to diagnose, especially early in the disease progression. This presentation follows the FDA’s Breakthrough Designation for the CorVista System Add-On to detect pulmonary hypertension and the recent FDA clearance of the coronary artery disease platform.”</p><p><br /></p><p>Pulmonary hypertension (PH), a life-threatening condition with significant morbidity and mortality, affects an estimated 1% of the world population. It is present in 10% of people over age 65 and 50% of patients with heart failure. Further, the subgroup of pulmonary arterial hypertension (PAH) is frequently diagnosed years after symptom onset, at a point when the pathophysiologic changes have become irreversible.</p><p><br /></p><p>Existing diagnostics for PH are insufficient; for instance, the sensitivity and specificity of Transthoracic Echocardiography (TTE) varies over a wide range. Moreover, TTE requires specialized equipment and technical support that is often unavailable. Herein we present the results of a machine-learned model addressing the need for an improved point-of-care test for PH in newly symptomatic subjects.</p><p><br /></p><p><br /></p><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg0nmfSEhx8ISgLBQ9FcCc5f_sKNsLwI5FUnqX9hWQu2p5EECBi3fKGieM106qKmzQQmcE5a8sx8IN-X0FXEHy-JKhtXjG7MY9UlUP0o88BtvfgZYqgcx1zntR73ce3yyT-W009vqP_YfPCEOFJsM6dyi505OvWgFqVpPoj2FofPIfiXQSF1LGluRSloMlx/s1478/Presentation%20of%20Machine%20Learning%20to%20Detect%20Pulmonary%20Hypertension%20at%20Point-of-Care%20de%20CorVista%20Health%2014_11_2023%20mini.PNG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="CorVista Health AHA Presentation of Machine Learning to Detect Pulmonary Hypertension at Point-of-Care" border="0" data-original-height="860" data-original-width="1478" height="186" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg0nmfSEhx8ISgLBQ9FcCc5f_sKNsLwI5FUnqX9hWQu2p5EECBi3fKGieM106qKmzQQmcE5a8sx8IN-X0FXEHy-JKhtXjG7MY9UlUP0o88BtvfgZYqgcx1zntR73ce3yyT-W009vqP_YfPCEOFJsM6dyi505OvWgFqVpPoj2FofPIfiXQSF1LGluRSloMlx/w320-h186/Presentation%20of%20Machine%20Learning%20to%20Detect%20Pulmonary%20Hypertension%20at%20Point-of-Care%20de%20CorVista%20Health%2014_11_2023%20mini.PNG" width="320" /></a></div><br /><div class="separator" style="clear: both; text-align: center;"><br /></div><br /><p style="text-align: center;"><br /></p><p>The presentation demonstrates the ability to develop a point of care method to detect PH, based on cardiac orthogonal voltage gradient (OVG) signals and photoplethysmographic (PPG) signals. A machine learned (ML) algorithm was developed to discriminate subjects with no evidence of diastolic dysfunction nor PH on TTE vs. those with mPAP≥25 mmHg from right heart catheterization.</p><p><br /></p><p>The AUC of the algorithm was 0.93, the sensitivity 87%, and the specificity 83%. Further, the performance is preserved in all subgroups, including pre-capillary PH. This supervised machine-learned model therefore provides strong preliminary evidence that an algorithm can be developed to assess the likelihood of PH in patients with new onset symptoms of cardiovascular disease... <a href="https://www.corvista.com/press-release/corvista-health-announces-aha-presentation-of-machine-learning-to-detect-pulmonary-hypertension-at-point-of-care/" rel="nofollow" target="_blank">CorVista Health's Press Release</a> -</p><p><br /></p><p><br /></p>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-18225118089412204112012-11-21T14:07:00.002-08:002012-11-21T14:08:24.216-08:00Ampliphi Biosciences : Encouraging Pre-Clinical Data on the Use of Phage-Based Therapies to Treat Bacterial Lung Infections<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="AmpliPhi Biosciences" border="0" height="67" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgQ8chmAE_cM5orcFCdQWOAgL7rlhE8v5uM-Vnr9CqxhBrllJrgUirvJrFlsnarHvEG7iajjkoffjTu0eIzW8VYdyi44qRHcGVAwt1hS4BeIwVGK4bNXvaTjzbqC46_KzXqiVAAPEOybtOx/s200/AmpliPhi+Biosciences.jpg" width="200" /></a></div>
October 18, 2012 - <a href="http://www.ampliphibio.com/">AmpliPhi Biosciences Corporation (APHB.PK) [‘AmpliPhi’]</a> presented encouraging data from a pre-clinical animal model study of acute infection with Pseudomonas aeruginosa at the <a href="https://www.nacfconference.org/">26th Annual North America Cystic Fibrosis Foundation Conference held 11-13 October in Florida, USA (NACFC)</a>. The data generated in collaboration with scientists at Institut Pasteur in Paris and using AmpliPhi’s phage discovery platform show that the company’s proprietary mix of bacteriophage is able to clear lung infection with efficacy comparable or superior to a high dose of an antibiotic shown to be effective against the infecting bacteria in the laboratory. Furthermore, the bacteriophage therapy rapidly eradicates bacteria in the oropharynx and lungs of the infected mice. In fact, its action appears to be faster than the antibiotic, showing efficacy at just six hours, with reduced dissemination of the infection... source : <a href="http://www.ampliphibio.com/index.php/news/view/ampliphi_presents_encouraging_pre_clinical_data_on_phage_therapies_to_treat">AmpliPhi Biosciences' press release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-48912473415033502712012-05-21T14:36:00.000-07:002012-05-21T14:38:19.928-07:00Chugai Pharmaceutical : Approval of an Orphan Drug, “Pulmozyme®,” a Recombinant Human Deoxyribonuclease I (rhDNase)<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Chugai Pharmaceutical Roche Group" border="0" height="33" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiUaYwqTnWnZ0UUCeJVYx88wlzgvQoaXnDTuWbkMAobdEksQhA6OePo3xmWyza7dpCLopOjg2QJzcf8oqYxGIPDhMmCL6lCIexJNnHc1Av_aF9WdaDul5lwaf-9YokvYOpOt5JfYNdHQR6e/s200/Chugai+Pharmaceutical+Roche+2012.gif" width="200" /></a></div>
March 30, 2012 (Tokyo) - <a href="http://www.chugai-pharm.co.jp/">Chugai Pharmaceutical Co., Ltd.</a> [Main Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayama (hereafter, “Chugai”)] announced that it has obtained approval on March 30, 2012, from the Ministry of Health, Labour and Welfare (MHLW), for Pulmozyme® Inhalation Solution 2.5mg (hereafter, “Pulmozyme®”)[recombinant human deoxyribonuclease I (rhDNase), generic name: dornase alfa] for the indication of “improvement of pulmonary function in patients with <a href="http://lungposition.blogspot.com/search/label/Cystic%20Fibrosis">cystic fibrosis</a>.” Pulmozyme® is designated as an orphan drug for this indication by the MHLW.<br />
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As a result of the evaluation by the “Review Committee on Unapproved Drugs and Indications with High Medical Needs*” held on April 18, 2011, it was concluded that it is reasonable that dornase alfa be filed for approval in this indication based on available data, and on July 15, 2011, the filing was made using overseas data. In overseas clinical studies, administration of dornase alfa by inhalation is confirmed to be effective for the improvement of pulmonary function and reduction of the risk of serious infection of the respiratory tract in cystic fibrosis patients, compared to placebo... <a href="http://www.chugai-pharm.co.jp/hc/ss/english/news/detail/20120330150000.html">Chugai Pharmaceutical's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-35338245841184788372012-04-24T09:16:00.000-07:002012-04-24T09:17:04.440-07:00Synairgen : Positive Phase II asthma clinical trial data<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:left; float:left;margin-right:1em; margin-bottom:1em"><img border="0" alt="Synairgen" height="39" width="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhm8y-pT8yU_mdKyNWyqh2Nh26IQh0RJt739wwD02LZcio0slofMSlvsSobwXf-6eVb92OIBGM9iVh2ksaddDMe1-dcmPNznYO6IZUO1m0nVRBnmmLoIxtXxaF7gVrOAfW_kUMybNFutpvz/s200/synairgen.jpg" /></a></div>
April 19, 2012 -
<a href="http://www.synairgen.com/">Synairgen plc (LSE: SNG)</a>, announces positive data from its Phase II clinical trial. This pioneering trial investigated the potential for SNG001 (inhaled interferon beta) to protect asthmatics from respiratory virus infections (principally the common cold) that can spread to the lung, which are a major cause of worsening asthma symptoms. It is estimated that viral infection is associated with up to eight out of ten asthma-related emergency department visits.<br />
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There are 5.4 million asthmatics in the UK (Asthma UK) and 25.7 million in the USA (Centers for Disease Control and Prevention).<br />
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The study investigated SNG001 in a population of 134 adult asthma patients, representing 'mild-moderate' through to 'severe' asthmatics, who caught a cold. Patients with 'difficult to treat' asthma, being approximately half of the patients in the trial, benefitted significantly from SNG001 treatment. This category of patient is estimated to represent between 10% and 20% of all adult asthma sufferers... <a href="http://www.synairgen.com/documents/19april2012PhaseIIpressreleasefinal.pdf">[PDF] Synairgen's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-12596077396656929652012-04-04T10:37:00.000-07:002012-04-04T10:38:18.707-07:00Almirall and Menarini : licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="Menarini" border="0" height="60" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi5m-RB254Gbo7xCoXA1tdtDDfE6B8b9jh-iieYunzxl4sRGQ1WXSSV5GvKABEZG339F5lzqfoPJlxmn9wVh8B0rYMjNkE6RTr9HMOx5wEZ6ZfjItQx5h8EDuPV5XMsWK3_sjKrRv6ZfbEs/s200/menarini+2012.jpg" width="60" /></a></div>
26 March 2012 - <b>Almirall and Menarini sign a licence agreement and commercial alliance for Aclidinium in the majority of European member states and a number of non-EU countries</b> -<br />
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<ul>
<li><i>Partnership fulfills Almirall's key criteria: territorial complementarity, non-competing portfolio assets, strong primary care capabilities and proven track record </i></li>
<li><i>Aclidinium, a new therapeutic option, is awaiting regulatory feedback in the US and Europe, while partnerships have already been established in the US, Japan and Korea </i></li>
<li><i>Chronic Obstructive Pulmonary Disease (COPD) affects nearly 44 million people in Europe1 and is considered by the World Health Organization (WHO) a global epidemic </i></li>
</ul>
<a href="http://www.almirall.es/">Almirall</a> and <a href="http://www.menarini.it/">Menarini</a> announce an agreement by which Almirall grants Menarini marketing rights for Aclidinium in most EU and other European countries for the treatment of <a href="http://lungposition.blogspot.com/search/label/Chronic%20Obstructive%20Pulmonary%20Disease%20%28COPD%29">COPD</a>. The agreement includes both aclidinium monotherapy and its combination with formoterol.<br />
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Menarini will have joint commercialisation rights across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries where Almirall retains sole marketing rights for the product) as well as Russia, Turkey and other CIS countries.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Almirall" border="0" height="61" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhgmI7SQZ1dxEQovgwAnEYthQkcKsgZGrk-i_TzMn1LP4uVnCkoo9LiNs5m-CtFBUNnqcfElZy-B_vIh8Zhz_6LhPI-KBET4oytL_8cmhJgKDvmSCAgVg98-RxoC5i4wGc6ubmlZoj0oEZb/s200/almirall.jpg" width="200" /></a></div>
<br />
In the territories for which Menarini holds rights to market aclidinium, it currently has a commercial infrastructure of over 5,000 sales representatives. These strong commercial capabilities and excellent track record in partnering have been key for Almirall in selecting Menarini. The commercial capabilities of Menarini are especially strong in Germany, Italy and France as well as Turkey, Central and Eastern Europe... <a href="http://www.almirall.es/webcorp2/cda/comunicacion_detalle_noticia.jsp?id=1638">Almirall's Press Release</a> - <a href="http://www.menarini.com/news/Latest-News/26-03-2012-Almirall-and-Menarini-sign-a-licence-agreement-and-commercial-alliance-for-Aclidinium-in-the-majority-of-European-member-states-and-a-number-of-non-EU-countries">Menarini's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-60279550210814025972012-03-21T09:54:00.000-07:002012-03-21T09:55:36.119-07:00Covidien : Definitive Agreement to Acquire superDimension, Ltd.<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Covidien" border="0" height="61" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgLZGtiui67iIAZB7Z9YI2h2P_oAkviHNcnFpnTkdMyoTZOFRWspY33nkoXbljTHLMcPpNyThQ9nJecJm6tvJIEO_D5zsT5UnCy5s5-meWZuhLC3dT-C-SjlWXQT4s6KL8g5rIKSk_wvCNd/s200/covidien.gif" width="200" /></a></div>
Mar. 19, 2012-- <a href="http://www.covidien.com/">Covidien (NYSE: COV)</a>, a leading global provider of healthcare products, announced a definitive agreement to acquire <a href="http://www.superdimension.com/">superDimension, Ltd.</a>, a private company based in Herzliya, Israel, that develops minimally invasive interventional pulmonology devices. <br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="56" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhipyFKYX0aLU3b3VHeGBAe3Y0R-zL1_e78DK7XwoQaqNCjyomAAbw-JXmyWPKUUXiVbXWofizp4ykHCN4fxNcy05t0FAF6grqH-7lPLkrNxspQzz7cBGkNBfglFP_qcJLZtXUnj79mZoTy/s200/superDimension+2012.gif" width="200" /></a></div>
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Covidien will acquire all of the outstanding capital stock of superDimension Ltd., for approximately $300 million, with future earn out payments possible. The transaction, subject to customary closing conditions, including receipt of certain regulatory approvals, is expected to be completed in the second calendar quarter of 2012.<br />
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With annual sales of approximately $30 million, superDimension’s i·Logic™ System uses Electromagnetic Navigation Bronchoscopy® to provide minimally invasive access to lesions deep in the lungs as well as mediastinal lymph nodes. By extending the reach of conventional bronchoscopes, the i·Logic System facilitates more effective evaluation of lung lesions, potentially enabling safer, more effective tissue biopsies... <a href="http://investor.covidien.com/phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1673793&highlight=">Covidien's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-32354540037972519692012-03-13T04:00:00.000-07:002012-03-13T04:01:36.300-07:00PhRMA : More Than 70 Medicines in Development for Asthma<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="PhRMA" border="0" height="60" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhRGDicGQjtA6Yy4XvQdj0KYkCVOxgxV3pruEdmuF1ebBHw1w-rR4uSthpeqDwAuvJL-0LTDkqlI0bXZde1a3Cl53GoXBvmiC1gkNomWOPKX8mkffeY73JGCiYk-U_NdDr9h73eLkOHHEoD/s200/PhRMA.gif" width="194" /></a></div>
March 5, 2012 — America’s biopharmaceutical research companies are developing 74 medicines to treat or prevent <a href="http://lungposition.blogspot.com/search/label/Asthma">asthma</a>, according to a report released today by the <a href="http://www.phrma.org/">Pharmaceutical Research and Manufacturers of America (PhRMA)</a>. All of the medicines are either in clinical trials or awaiting review by the <a href="http://www.fda.gov/">Food and Drug Administration</a>.<br />
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“Asthma is a lifelong disease that can limit a person’s quality of life and even lead to death, if not treated properly,” said PhRMA President and CEO John J. Castellani. “The good news is that potential treatments highlighted in this report offer asthma sufferers new hope of living a healthier, more productive lives.”<br />
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Asthma is a narrowing of the airways to the lungs caused by inflammation in the air passages, resulting from both genetic and environmental influences. Today, more than 24 million American adults and children suffer from asthma, with the prevalence increasing 12 percent in the last decade, according to the Centers for Disease Control and Prevention. Each day, 40,000 Americans miss school or work due to asthma, costing the U.S. economy an estimated $56 billion each year in direct and indirect costs... <a href="http://www.phrma.org/media/releases/more-70-medicines-development-asthma">PhRMA's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-22094196941091279122012-02-13T13:44:00.000-08:002012-02-13T13:44:38.451-08:00Quanterix : to Collaborate With the Forsyth Institute and Beth Israel Deaconess Medical Center to Develop Tuberculosis Test<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Quanterix" border="0" height="179" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjt3oQOoJmb1UUP8FPL92hWEnqkdLDr-y7zEtSbrtEAPNOgMLG4ubyTx2Hwv4cmsHMvL4AIyzi53sXSxROLpu8917gHIDVTgLplu3VNyAEindpGURk5sNUOqFUSBYkn4rl7jwWOvIzoX-K0/s200/quanterix.gif" width="200" /></a></div>
Feb. 9, 2012 - <i>Partnership to Develop Innovative Pathogen Detection Test </i>-<br />
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<a href="http://www.quanterix.com/">Quanterix Corporation</a>, a company enabling a new generation of molecular diagnostic tests based on its revolutionary Single Molecule Array (SiMoA™) technology, announced that it will apply its cutting-edge technology towards the development of an improved test to aid in the diagnosis of active tuberculosis (TB). In collaboration with the <a href="http://www.forsyth.org/">Forsyth Institute</a> and <a href="http://www.bidmc.org/">Beth Israel Deaconess Medical Center (BIDMC)</a>, Quanterix will validate novel low abundance protein biomarkers that may be useful for identifying individuals with active disease. Through this strategic partnership, Quanterix will continue to expand its infectious disease applications to include the development of a fast and simple test that will provide accurate diagnosis of active TB in high-burden countries.<br />
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"The Forsyth Institute has utilized a proteomics-based approach to identify a panel of novel M. tuberculosis markers present in the urine of human patients with active TB, but conventional protein detection platforms lack the analytical sensitivity to reliably detect these proteins in urine or blood. Using SiMoA, we are routinely able to improve the sensitivity of existing immunoassays by more than 1,000-fold, enabling accurate measurement of analytes that have previously been considered undetectable. Applying our technology to evaluate biomarkers that could not otherwise be detected will allow us to address a variety of important unmet medical needs, including the development of an improved test for the diagnosis of active tuberculosis," said David Duffy, Ph.D., Vice President of Research at Quanterix... <a href="http://www.quanterix.com/news/pressReleases/GatesTBRelease.html">Quanterix 's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-82414747570836535652012-02-07T14:52:00.000-08:002012-02-07T14:52:49.496-08:00PhRMA : More Than 50 Medicines in Development for COPD, Third Leading Cause of Death in U.S.<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:right; float:right; margin-left:1em; margin-bottom:1em"><img border="0" alt="Pharmaceutical Research and Manufacturers of America PhRMA" height="60" width="194" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhFQ3eo7H5cQs8U3SPIGSO_wh4wP5_ecZu69NuB5eVcQ_yTW01PhHZwcFCc-poV7FDiYpuVCledFwD5kIqrqbgrLUGCul69iQJswQDCLQl2QMqvCkr2fbuiu2I44IA37OdLNGjXoTFtsu4f/s200/PhRMA.gif" /></a></div>
February 2, 2012 — America’s biopharmaceutical research companies are working on 54 medicines to treat <a href="http://lungposition.blogspot.com/search/label/Chronic%20Obstructive%20Pulmonary%20Disease%20%28COPD%29">chronic obstructive pulmonary disease (COPD)</a>, according to a report released by the <a href="http://www.phrma.org/">Pharmaceutical Research and Manufacturers of America (PhRMA)</a>. These exciting therapies are in late-stage development, meaning they are either in clinical trials or awaiting review by the Food and Drug Administration (FDA). <br />
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Today, more than 13 million American adults suffer from COPD, one of the most common lung diseases in the U.S. A chronic, progressive lower respiratory disease that encompasses two main conditions – chronic bronchitis and emphysema – COPD is characterized by obstructed airflow to the lungs that interferes with normal breathing. People with COPD may be limited in their ability to work, exercise and perform routine activities.<br />
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According to the National Institutes of Health (NIH), the number of patients with COPD is increasing. In addition to those who have been diagnosed with the disease, 12 million Americans likely have COPD without knowing it.<br />
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“Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease,” said PhRMA President and CEO John J. Castellani. “The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treating respiratory diseases such as COPD offer great hope to improve and save the lives of future patients.”... <a href="http://www.phrma.org/media/releases/more-than-50-medicines-in-development-for-copd-third-leading-cause-of-death-in-us">PhRMA's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-49813291768831929122012-01-26T14:23:00.000-08:002012-01-26T14:23:43.769-08:00Uptake Medical : Australian Therapeutic Goods Administration Approval of InterVapor for Patients With Severe Emphysema<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:left; float:left;margin-right:1em; margin-bottom:1em"><img border="0" alt="Uptake Medical" height="37" width="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjDdthtbanGzJzruNfLzZhOuBgfPRHxfMv-4Oqpu7pHEbrMZjAJpY0Hk0BKscT7Gs_L9jcqc3fdB3qV_dtF3pdK4YwKtFGQPfPvXjdeDCHJVcULX9VO4pJhQLMxxKGL0rbicGAN5oFQ-SBZ/s200/Uptake+Medical.jpg" /></a></div>
Dec. 21, 2011 – <a href="http://www.uptakemedical.com/">Uptake Medical®</a> announced that it received <a href="http://www.tga.gov.au/">Australian Therapeutic Goods Administration (TGA)</a> approval for its InterVapor™ System for endoscopic lung volume reduction for the treatment of severe emphysema. InterVapor is the first non-surgical, endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body’s natural healing processes without leaving implants or foreign materials in the lung.<br />
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Clinical efficacy of InterVapor has been established by the multi-center VAPOR trial which showed a reduction in lung volume as well as statistical and clinical significance in lung function improvement (FEV1) and health-related quality of life (SGRQ) at six months.<br />
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“Our involvement with Uptake Medical and InterVapor goes back to the first usage in patients, and we are delighted to see the TGA approval,” commented Professor Gregory Snell, head of lung transplant services at the Alfred Hospital in Melbourne, Australia. “InterVapor has continued to demonstrate clinical efficacy and safety and we look forward to offering InterVapor to our patients.”... <a href="http://www.uptakemedical.com/uptake-medical-announces-tga-approval-of-intervapor-for-patients-with-severe-emphysema">Uptake Medical's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-19902127205607466082012-01-19T15:09:00.000-08:002012-01-19T15:18:37.206-08:00NovaBiotics : plans for cystic fibrosis drug after EU grants orphan status<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img alt="NovaBiotics" border="0" height="49" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhZLALJ-VgiAmwSvTTUVpIxkkb0eB1-68BhkMBYeMD-hz9yNk94hwxU5FNBXvaUUWLMa3aWZH_TvjR0Dmw-IItCmzu1473dulPctnaOk-0VpZBm7DwpMOg-vhOuojyqqj_PANeS8uQWUE_R/s200/NovaBiotics.jpg" width="200" /></a></div>
<i>20th December 2011</i> - <b>NovaBiotics reveals plans for cystic fibrosis drug after EU grants orphan status</b> -<br />
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Bolstered by the an EU orphan drug designation for its drug candidate for cystic fibrosis, Lynovex (cysteamine), UK-based <a href="http://www.novabiotics.co.uk/">NovaBiotics </a>revealed to <a href="http://www.scripintelligence.com/researchdevelopment/NovaBiotics-reveals-plans-for-cystic-fibrosis-drug-after-EU-grants-orphan-status-324987">Scrip</a> that it plans to begin a first-in-man, safety/tolerability and evidence of efficacy study of the product in 2012, followed by other trials in 2013.<br />
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The company announced that the <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000263.jsp&mid=WC0b01ac0580028e30">Committee on Orphan Medicinal Products (COMP)</a> of the <a href="http://www.ema.europa.eu/">European Medicines Agency (EMA)</a> has granted orphan status to the novel dual mucolytic-antibacterial drug for the treatment of <a href="http://lungposition.blogspot.com/search/label/Cystic%20Fibrosis">cystic fibrosis</a> and added that it is "currently in discussions with a number of interested parties with a view to licensing or co-developing the drug".<br />
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NovaBiotics stated it would "now progress with follow-on orphan applications for paediatric use and also applications for orphan drug designation in the US".<br />
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"This novel drug candidate is expected to be tested in patients in 2012," the biotech firm highlighted. It told Scrip that the study slated for next year would test Lynovex when used in conjunction with conventional inhaled ABX (antibiotic) therapies in the first instance. In 2013, NovaBiotics said it would initiate a second and third trial to further assess efficacy.<br />
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The company confirmed that it intends to partner the product, and "as per our core business model [this is] most likely after the second clinical study". With respect to its finances, it said: "NovaBiotics remains fully equity funded (still pre-revenue) and this is how development has been/will be funded in the short-term for Lynovex, but as the programme develops towards final clinical studies, revenue from Novexatin and Luminaderm commercialisation deals will be reinvested into the Lynovex programme."... <a href="http://www.novabiotics.co.uk/News/Press.html#CFREVEAL">NovaBiotics' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-71675827249132981132012-01-16T05:39:00.000-08:002012-01-16T05:39:35.011-08:00GSK: Professor Rob Horne discusses the MyAsthma programme<iframe width="480" height="270" src="http://www.youtube.com/embed/ZJXQhe1TkhE?fs=1" frameborder="0" allowFullScreen=""></iframe>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-48951789704629228002012-01-16T05:32:00.000-08:002012-01-16T05:40:38.128-08:00Novartis : Becoming Christopher a fictional video trailer about living with Cycstic Fibrosis<iframe width="480" height="270" src="http://www.youtube.com/embed/-Z5lOrmfjKg?fs=1" frameborder="0" allowFullScreen=""></iframe>Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-85982206191715509592012-01-12T14:58:00.000-08:002012-01-12T14:58:58.438-08:00Geron : Phase 2 Trial of GRN1005 in Brain Metastases From Lung Cancer<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="Geron" border="0" height="49" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgvlGACpQjEmDPdtzofIaUlDNsKXt_XoyT9LJ3hPuWQIxsiDP3Di8W9ezfaSEUyEFbZn09zoGsHToHHtCObL4ZufIEv5FktUyQg8SikTDtrbcrGjxiC7iRQLUcARc9HqEuuRp_eUtsihr5c/s200/geron.gif" width="121" /></a></div>
December 22, 2011 - <a href="http://www.geron.com/">Geron Corporation (Nasdaq: GERN)</a> announced the initiation of GRABM-L (GRN1005 Against Brain Metastases - Lung cancer), a Phase 2 clinical trial to evaluate GRN1005 in patients with brain metastases arising from non-small cell lung cancer (NSCLC). GRN1005 is the company's lead LRP-directed peptide-drug conjugate (LRP-directed PDC) and consists of the cytotoxic drug paclitaxel linked to a peptide (Angiopep-2) that targets the LRP receptor to cross the blood-brain barrier (BBB) and to target tumors in the brain.<br />
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"With the treatment of the first patient in the GRABM-L study, we have initiated both of the planned Phase 2 clinical trials of GRN1005 in patients with cancer metastases in the brain, a significant unmet medical need for which there are currently no approved drug therapies," said Stephen M. Kelsey, M.D., Geron's Executive Vice President, Head of R&D and Chief Medical Officer. "We have been encouraged by the preliminary evidence of anti-tumor activity against brain metastases observed in the Phase 1 study of GRN1005, and we hope to confirm these results in our Phase 2 trials."<br />
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<i>Phase 2 Clinical Trial Design (GRABM-L) </i><br />
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The purpose of the Phase 2 study is to assess the efficacy, safety and tolerability of GRN1005 in patients with brain metastases from NSCLC. The trial plans to enroll 50 patients.<br />
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GRN1005 will be administered at a dose of 650 mg/m2 by intravenous (IV) infusion every three weeks. The primary efficacy endpoint for the trial is overall (intra-cranial and extra-cranial disease) objective response rate. Key secondary endpoints include duration of overall objective response, duration of overall progression-free survival and six month overall survival....<a href="http://ir.geron.com/phoenix.zhtml?c=67323&p=irol-newsArticle&ID=1642217&highlight=">Geron's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-88422638240370788172012-01-06T01:26:00.000-08:002012-01-06T01:26:23.150-08:00Orchid Pharma : successful completion of Phase I study of its novel PDE4 inhibitor molecule, OCID 2987<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear:right; float:right; margin-left:1em; margin-bottom:1em"><img border="0" alt="Orchid Pharma" height="59" width="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgsGxWV0w_MfQl5jRQKPFsuifuqKP256XQiwgYU1p9o9UQ89_QF5y7sCR81a9KyJVy3DfAVlVBFwEw_PoIg8pNpqiuCzfDiJg380R3ibIYZ2F-N6F3N2lYJEQcqsinpZsG8WTIb-ltJw-i6/s200/Orchid+Pharma.jpg" /></a></div>
January 02, 2012 - The Chennai-based global pharma major, <a href="http://www.orchidpharma.com/">Orchid Chemicals & Pharmaceuticals (Orchid)</a> stated that it has successfully completed in Europe a Phase I trial of its orally administered PDE4 (phosphodiesterase 4 inhibitor) molecule OCID 2987 positioned for the treatment of inflammatory disorders including <a href="http://lungposition.blogspot.com/search/label/Chronic%20Obstructive%20Pulmonary%20Disease%20%28COPD%29">COPD (Chronic Obstructive Pulmonary Disease)</a>.<br />
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The Phase I study was conducted to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of OCID 2987 at escalating single or repeated doses on healthy male volunteers. OCID 2987 was well tolerated up to the highest doses administered in both single and repeat dose studies and did not demonstrate a potential for nausea/emesis, a common unacceptable side-effect with most PDE4 inhibitors. There were no serious adverse events or any cardiac safety concerns reported in the study... <a href="http://www.orchidpharma.com/mc_mediareleases_details.aspx?id=25">Orchid Pharma's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-41740532143511396722011-12-12T09:45:00.000-08:002011-12-12T09:45:39.221-08:00Almirall and BioFocus : collaboration to find new hit compounds against key targets<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img alt="BioFocus a Galapagos company" border="0" height="99" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj5JfgoFNPk0pqQ9zKRkQX9HPMXQRso9Yf5pEOj4B4JACrRb5f3KW67v-WERVlSQtf7w9C6MKv0G58Yw_qQdV6TknlxLhyJU5GJFJApWtR5SOWcuVFDl9JJ5yJE65VOe1eh5ObHvr75Ggyc/s200/BioFocus.gif" width="200" /></a></div>
November 15, 2011 - <i>Targets are related to the treatment of respiratory and inflammatory conditions</i> -<br />
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The pharmaceutical company <a href="http://www.almirall.es/">Almirall S.A.</a> and <a href="http://www.biofocus.com/">BioFocus</a>, an integrated drug discovery partner, announced they have entered into a collaboration agreement to find new hit compounds against key targets of interest to Almirall. These compounds will be used to support projects aimed at the treatment of respiratory and inflammatory conditions.<br />
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Under the terms of the collaboration, BioFocus will apply its screening technologies and compound collections to an undisclosed number of Almirall projects.<br />
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Almirall" border="0" height="61" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgH_dEexy00A1DO8Kc3Hx9H_aJUOo7eR5z6kvZVx0-IynwT4xSg7QPq7kflpbqHNznUm_1owVnVlSfb4XoHXB7hbsz7Gtf3ZqIn3CU20H7iSFLZkRTFw7wMXGEsUCVtWsv2RG6-ZB-_joAJ/s200/almirall.jpg" width="200" /></a></div>
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“We have been impressed by the depth of the BioFocus technology platforms, the size, content and diversity of the available compound decks and the obvious strength and experience of the scientists that will be engaged on our projects working on respiratory and inflammatory conditions”, said Dr. Bertil Lindmark, CSO, Executive Director R&D of Almirall.<br />
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“We are delighted to form a drug discovery alliance with one of Europe’s leading research-based pharmaceutical companies,” added Dr. Kate Hilyard, VP Biological Sciences, BioFocus... <a href="http://www.biofocus.com/news,almirall-and-biofocus-announce-collaboration-to-find-new-hit-compounds-against-key-targets_213.htm">BioFocus' Press Release</a> - <a href="http://www.almirall.es/webcorp2/cda/comunicacion_detalle_noticia.jsp?id=1595">Almirall's Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-74904147722154488042011-11-24T11:30:00.001-08:002011-11-24T11:36:54.581-08:00Selecta Biosciences : Phase 1 Clinical Study of SEL-068, a First-in-Class Synthetic Nicotine Vaccine for Smoking Cessation and Relapse Prevention<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" alt="Selecta Biosciences" height="60" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgjIKD7TPUSAbXaeBRRooas4LHDXPaPqPseLemxnIP3zJZ7apNRH-aLW9LldRAVLmXxu1tTH_pxAQRPxRr_MazzXW7LezdtMqXZ8mAa04iJMp1rrm1sXg4lDFCiFK6UflrZGBN_mOhPv3Ix/s200/Selecta+Biosciences.gif" width="200" /></a></div>
November 21, 2011 - <i>First Clinical Program for Selecta's Synthetic Vaccine Particle Platform with Broad Potential for a Range of Therapeutic Applications Including Infections, Cancer, Allergies, and Autoimmune Diseases</i> –<br />
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<a href="http://www.selectabio.com/">Selecta Biosciences, Inc.</a>, a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention. SEL-068 is the first product candidate to enter clinical evaluation from Selecta's proprietary Synthetic Vaccine Particle (SVP™) Platform, and has the potential to become the first nanoparticle vaccine that is synthetically engineered, distinct from conventional biological vaccine manufacturing processes.<br />
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"This is the first time ever that a fully integrated synthetic, nanoparticle vaccine is being tested in human clinical trials and is a very important milestone in the translation of Selecta's SVP technology," said Ulrich von Andrian, Ph.D., M.D., Edward Mallinckrodt Jr. Professor of Immunopathology at Harvard Medical School and Selecta co-founder. "Selecta has demonstrated its ability to rationally design immunotherapeutics and induce a robust targeted immune response. SVP technology will revolutionize the way vaccines will be designed, produced and applied."<br />
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The Phase 1 clinical study of SEL-068 is a double-blind, placebo-controlled, ascending dose study in healthy, non-smoking and smoking volunteers. In addition to safety, the study will evaluate the vaccine's potency through the measurement of concentrations of nicotine-specific antibodies. Selecta expects to report initial results from this Phase 1 study in the first half of 2012.<br />
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Because SEL-068 is fully synthetic, the immune response is entirely focused on nicotine and avoids off-target responses to biological carriers typically used with other vaccine technologies. The resulting high antibody concentrations induced by SEL-068 have the potential to absorb inhaled nicotine, preventing it from reaching the brain and triggering the addictive response... <a href="http://www.selectabio.com/news/recent-news/Selecta-Biosciences-Initiates-Phase-1-Clinical-Study-of-SEL-068.cfm">Selecta Biosciences' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-2083443511454922242011-11-17T14:55:00.001-08:002011-11-17T15:06:38.912-08:00Quest Diagnostics : Launch of Simplexa(TM) Direct Test for Influenza and Respiratory Viruses in Europe<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="84" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiDilblo-4uKGXxBWwAvF4G9FWWBe22bSa2D3pg4IX2LgABfmgXgRA2x1ZIF__Rb3c6nogvPtj7e7beaB4cBe8-ndjHAc-BvW9-hzp8GPvKcwnlloGv6Uq5GMmph2mY4pCeRlzS8G10wI2A/s200/Quest+Diagnostics.gif" width="200" /></a></div>
Nov. 1, 2011 - <i>Focus Diagnostics product eliminates nucleic-acid sample extraction with proprietary technology, for faster testing</i> -<br />
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<a href="http://www.questdiagnostics.com/">Quest Diagnostics Incorporated (NYSE: DGX)</a>, the world's leading provider of diagnostic testing, information and services, announced the CE mark and European availability of the Simplexa Flu A/B & RSV Direct test on the 3M(TM) Integrated Cycler. The new test, from the company's <a href="http://www.focusdx.com/">Focus Diagnostics</a> business, uses a proprietary technique to eliminate nucleic-acid sample extraction, a time-consuming process required by other molecular test products, for faster results reporting.<br />
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"Simplexa Direct chemistry employs a novel technology that overcomes a critical limitation found in most molecular test kits on the market: the need for extraction of nucleic acids," said Maurice Exner, Ph.D., vice president of research and development, Focus Diagnostics. "With this advance, molecular testing will be far easier and faster for labs to perform than before. We believe the Simplexa Direct method is an important step toward enabling a greater range of healthcare professionals to access quality molecular testing. We look forward to introducing our first Simplexa Direct product, for influenza and respiratory syncytial virus testing, to laboratories in Europe."
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<a imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img alt="Focus Diagnostics" border="0" height="103" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh89cBK4X4CvyaGTGgcl8c9D0zVEngJopc9wfayO8Ph2tXWJzRr8EW2Fqn8U4EU4nqgrPpJEgeFduJnO5yZtAuuozh5s_s0DT4UyKlmDpvcOY5q_iIHspkd0mqYkKx-yY__IT8WPuOqH2Y7/s200/Focus+Diagnostics.jpg" width="166" /></a></div>
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Nucleic-acid extraction is a process requiring specialized molecular equipment and trained personnel. It involves extracting DNA or RNA from a blood, plasma or other specimen type for testing. The nucleic-acid extraction process, used in most commercial molecular test kits, can add approximately 60 to 90 minutes to total testing time. Focus Diagnostics has replaced the process with a proprietary reaction-mix technique. The company expects to use the proprietary technology in future Simplexa products.<br />
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Simplexa Flu A/B & RSV Direct is an addition to the influenza and respiratory franchise of award-winning FDA-cleared and CE-marked assays available through Focus Diagnostics... <a href="http://ir.questdiagnostics.com/phoenix.zhtml?c=82068&p=irol-newsArticle&ID=1624357&highlight=">Quest Diagnostics' Press Release</a> - <a href="http://www.focusdx.com/press-releases/quest-diagnostics-announces-launch-of-simplexa%E2%84%A2-direct-test-for-influenza-and-respiratory-viruses-in-europe/">Focus Diagnostics' Press Release</a> -Unknownnoreply@blogger.comtag:blogger.com,1999:blog-6973237269577109710.post-40140906573265485532011-11-07T14:57:00.000-08:002011-11-07T14:57:44.975-08:00VentriPoint : Clinical Studies of Pulmonary Arterial Hypertension Application of Right Heart Analysis System<div class="separator" style="clear: both; text-align: center;">
<a imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" alt="VentriPoint" height="37" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjOoRIwcGYgNDsfAx85vRWkKz9nE7nSsSQx-7xWJckTrjg5ymsfhs-Jz9D5O7JuJqpBotkItMiosOjCqhiAWfs3hqDgVN0BvASOFEx0JAZ9NUnL4WAGxid2qDmxllepNz_mYlZ-w3Bldl-s/s200/VentriPoint.gif" width="200" /></a></div>
Nov. 1, 2011 - <i>The University of Chicago Completes First Patient</i> -<br />
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<a href="http://www.ventripoint.com/">VentriPoint Diagnostics</a> (TSX VENTURE:VPT)(PINK SHEETS:VPTDF) announces the University of Chicago has secured a VentriPoint Medical System (VMS™) and has begun the clinical evaluation of the database for patients with Pulmonary Arterial Hypertension (PAH).<br />
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The study will be led by four highly regarded cardiac specialists from the University of Chicago; Dr. Roberto Lang, former President of the American Society of Echocardiography and Director of the Echo Lab; Dr. Mardi Gomberg, expert clinician and researcher in the field of pulmonary hypertension; Dr. Amit Patel, Director of Cardiac MRI; and Dr. Benjamin Freed, Lead Cardiologist.<br />
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"I expect that an assessment of RV volume and function using the VMS™ will become part of the routine clinical ultrasound evaluation for patients at risk for PAH," stated Dr. Roberto Lang. "A simple way to detect and monitor PAH is gravely needed and this methodology will be extremely useful to quantify interventions (therapeutic and surgical) performed on the right ventricle," Dr. Lang added.<br />
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It is anticipated this first clinical study will take four to six weeks and will verify the accuracy of the system in patients known to have PAH. If successful, a multicenter clinical trial will be initiated to compare VMS™ with MRI as part of a submission to the FDA as part of a 510K submission.<br />
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Dr. George Adams, VentriPoint President and CEO stated, "The Company will leverage the success of the VentriPoint technology with congenital heart disease to address the needs of a significantly larger population of patients at risk for pulmonary hypertension."<br />
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The VMS™ is for investigational use only in the United States and approved for clinical use in Canada and Europe... <a href="http://www.ventripoint.com/documents/11.11.01UCH.pdf">[PDF] VentriPoint Diagnostics' Press Release</a> -Unknownnoreply@blogger.com