Masimo Rainbow SET Pulse CO-Oximetry Effective as a Universal Screening Tool to Identify Cases of Unsuspected CO Poisoning in ERs

March 19, 2008 – Masimo, the inventor of Pulse CO-Oximetry and Measure-Through-Motion & Low Perfusion Pulse Oximetry, reported that a new clinical study, recently published in the Journal of Emergency Medicine, found the Masimo Rainbow SET Rad-57 Pulse CO-Oximeter to be "a safe, easily applied tool at triage that can identify cases of unsuspected elevated levels of carbon monoxide (CO) poisoning" that would otherwise have gone undetected.

Researchers at the Rhode Island Hospital, where the study was conducted, also concluded that universal SpCO® screening may prevent morbidity through early identification and treatment intervention, stating that: "we can point to several cases during our study period in which patient outcomes were different based upon availability of SpCO, recorded at triage."

The study titled "Noninvasive Pulse CO-Oximetry Screening in the Emergency Department Identifies Occult Carbon Monoxide Toxicity" was conducted over a nine-month period on more than 10,850 patients presenting to the Emergency Department at the Rhode Island Hospital in Providence, Rhode Island, by a research team of emergency medicine physicians from the Warren Alpert Medical School at Brown University and the Emergency Department of Rhode Island Hospital, headed by Dr. Selim Suner... Masimo's Press Release -

Lilly : US$4.4 Million to the WHO for MDR-TB Program Expansion

Mar 12, 2008 - Eli Lilly and Company announced its four-year grant of US$4,384,000 to the World Health Organization (WHO) for scaling up its global capacity to manage multi-drug resistant tuberculosis (MDR-TB) programs.

The grant covers four activities, starting with the technical assistance the WHO will provide to developing countries that the Global Fund to Fight AIDS, Tuberculosis and Malaria operations do not cover. The WHO will provide assistance to some 25 countries in their clinical management of MDR-TB, infection control, laboratory facilities and community outreach. Second, the WHO will conduct workshops for health care personnel so they can better design and manage TB programs, for laboratory technicians so they can test for first and second line drug susceptibility, and for administrative personnel to record and report on TB incidence in their countries. A third component is support for training global MDR-TB experts so they can expand training in developing countries, run workshops in infection control, and strengthen laboratories for proper diagnosis and treatment. Finally, the grant will support the field-testing and evaluation of a new information system to record and report on MDR-TB rates in two countries... Lilly's Press Release -

Nereus Pharmaceuticals : Clinical Trail of NPI-2358 in Non-Small Cell Lung Cancer Following Encouraging Phase 1 Data

March 20, 2008 - Nereus Pharmaceuticals, Inc., a pioneer in drug discovery from marine microbial sources, announced that enrollment has begun in a Phase 1b study evaluating the vascular disrupting agent (VDA) NPI-2358 in combination with standard chemotherapy in patients with non-small cell lung cancer (NSCLC). This study follows on positive outcomes in a Phase 1 single-agent clinical trial assessing the safety, pharmacokinetics, pharmacodynamics (PK/PD) and efficacy of NPI-2358 in various tumor types.
The open-label Phase 1b study will assess escalating doses of NPI-2358 in combination with docetaxel in patients with NSCLC who previously failed at least one chemotherapy regimen. The existing preclinical and clinical data suggests that VDAs may be complementary or synergistic with chemotherapeutics and anti-angiogenesis agents due to the different targets and mechanisms of action. NPI-2358 has a dual effect on tumors: It selectively attacks existing tumor blood vessels leading to hemorrhagic tumor necrosis without affecting normal vasculature, and it has a direct apoptotic effect on tumors cells. NPI-2358 in combination with chemotherapeutic agents in human xenograft models of NSCLC and other cancers was markedly more effective than either treatment alone... Nereus' Press Release -

Masimo : Schiller AG Adopts its Rainbow SET as Their Technology Platform of Choice for Patient Monitoring Devices Worldwide

March 25, 2008 – Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, announced an agreement with Switzerland-based Schiller, a leading European manufacturer and supplier of electrocardiographs, spirometers, patient monitors and external defibrillators, to integrate the Masimo Rainbow SET technology platform as the foundational technology of choice for all their patient monitoring solutions worldwide.

Masimo Rainbow SET, an upgradeable noninvasive technology platform featuring the accuracy and reliability of Masimo SET Measure-Through Motion and Low Perfusion pulse oximetry, is revolutionizing patient monitoring by significantly expanding pulse oximetry's ability to capture, track and monitor blood constituents that previously required invasive procedures. The first and only technology platform capable of continuously and noninvasively measuring total hemoglobin (SpHb™) and oxygen content (SpOC™) (both pending FDA clearance), in addition to carboxyhemoglobin (SpCO™), methemoglobin (SpMet™), pleth variability index (PVI™), oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate—Masimo Rainbow SET is helping to advance patient safety and improve care worldwide... – Masimo's Press Release -

Accuray : CyberKnife Radiosurgery Used to Treat Lung Tumors at 90 Percent of Centers Worldwide

March 26, 2008– Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced that approximately 90 percent of CyberKnife centers worldwide are now treating lung cancer with the CyberKnife^® Robotic Radiosurgery System*. The number of lung cancer patients is growing significantly as well, with more than 5,000 individuals receiving CyberKnife treatments to date.

Lung cancer deaths are predicted to increase dramatically, according to a recent report from the World Health Organization (WHO). Lung cancer is expected to become more prominent in the underdeveloped world as a result of an anticipated rise in the use of tobacco products, which is the primary cause of approximately 80 percent of all lung cancer. The WHO “Report On The Global Tobacco Epidemic” projects that lung cancer incidence will increase from 18 million cases in the 20th century to 180 million cases in the 21st century worldwide. The majority of lung cancer cases are expected to be concentrated in 10 countries: China (30 percent of all cases), India (10 percent), Indonesia, Russia, the United States, Japan, Brazil, Bangladesh, Germany and Turkey... Accuray 's Press Release -

Actavis : approval of generic Wellbutrin SR and Zyban tablets in the U.S.

March 27, 2008 - Actavis Group, the international generic pharmaceuticals company, announced that it has received two separate approvals from the U.S. Food & Drug Administration to market Bupropion Hydrochloride extended-release tablets (SR). Distribution of the products will commence immediately...
...Bupropion Hydrochloride extended-release tablets (SR), available in 150mg strength, are the generic equivalent to Zyban and are indicated as an aid to smoking cessation treatment... Actavis' Press Release -

Merck Statement on the FDA Early Communication of an Ongoing Safety Review of Montelukast (SINGULAIR™)

March 27, 2008 - Merck & Co., Inc. issued the following statement in response to the FDA Early Communication of an Ongoing Safety Review of Montelukast (SINGULAIR™) that was posted today on the FDA website.

SINGULAIR has been marketed in the US for 10 years and millions of patients have been prescribed SINGULAIR in the US and around the world. Merck voluntarily updated the worldwide product label for SINGULAIR in October 2007 to include "suicidal thinking and behavior" and included similar changes to the patient product information. These actions were based on a very limited number of post-marketing adverse event reports that Merck has received. Since that time, Merck has worked with the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians.

Information from post-marketing reports is incorporated by Merck into the product label and patient product information as appropriate to help inform healthcare practitioners and patients. The fact that an adverse event has been reported to Merck and to regulatory agencies does not reflect a conclusion that the post-marketing event is caused by SINGULAIR. In general, a post-marketing adverse event may be caused by underlying disease, genetic condition, the medication, concomitant medications or background event that may occur in any population... Merck's Press Release -

Kamada : Advancement in its Phase II Trial with Aerosolized AAT to treat CF: First Group of Patients Completes Treatment

March 19, 2008 - Kamada, a biopharmaceutical company developing, manufacturing and marketing specialty, life-saving therapeutics, announces of an advancement in the company's Phase II clinical trial to test the efficacy of its aerosolized AAT (Alpha-1 Antitrypsin) product delivered via an optimized eFlow electronic nebulizer (PARI Pharma) to treat Cystic Fibrosis (CF). The first group of patients has completed treatment with a satisfactory safety profile and with no special adverse events. The trial is ongoing, according to original planned timelines, with the company's aim to complete it by the end of 2008... Kamada 's Press Release -

EpiCept, Myriad Genetics, Azixa

Mar 06, 2008 - EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced that it has earned a milestone payment from Myriad Genetics, Inc., for progress due to patient dosing in a Phase II trial being conducted by Myriad for Azixa(TM) (MPC-6827) in melanoma that has spread to the brain. Azixa is an apoptosis inducer with vascular disrupting activity licensed as part of a series of compounds by EpiCept to Myriad as part of an exclusive, worldwide development and commercialization agreement.

The milestone payment is in conjunction with progress made in a Phase II trial of Azixa in patients with melanoma. Myriad had previously announced the initiation of two additional Phase II trials for Azixa in patients with non-small-cell lung cancer that has spread to the brain and glioblastoma multiforme brain cancer...

...Myriad has completed two Phase 1 clinical trials of Azixa in a total of 66 patients, one in patients with advanced or metastatic cancers and the other in patients with known brain metastases. In Phase I data previously reported by Myriad, Azixa appeared to have a biological effect on patients' cancers from many different primary tumors, including non-small-cell lung cancer, which is consistent with the mechanism of the drug candidate.... EpiCept's Press Release -

Poniard Pharmaceuticals : Additional data presentation on picoplatin overcoming platinum resistance in small cell lung cancer

March 19, 2008 - Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced that preliminary data from a Phase 1 trial of an oral formulation of picoplatin in patients with solid tumors will be presented at the 2008 American Association for Cancer Research meeting to be held from April 12-16 in San Diego, CA. In addition, preclinical data of picoplatin overcoming platinum resistant small cell lung cancer cells in platinum resistant cell lines will also be presented at a separate poster presentation... Poniard's Press Release -

AstraZeneca : Phase III Studies Of The Investigational Drug Vandetanib (ZACTIMA®) In Non-Small Cell Lung Cancer (NSCLC)

March 12, 2008 – AstraZeneca (NYSE: AZN) announced that it has completed patient enrollment in two pivotal Phase III studies for vandetanib, the company’s investigational, once-daily oral anti-cancer drug, for the second-line treatment of non-small cell lung cancer (NSCLC). The two studies – ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer) and ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) – are the second and third of four ongoing studies to complete enrollment. Data from the studies are expected later this year and the broad development program is on track for a first regulatory submission in 2008... AstraZeneca's Press Release -

SPO Medical : Shipping PulseOx 6000(TM) and PulseOx 6100(TM)

February 26, 2008 - SPO Medical Inc. (SPOM), a leading developer of biosensor and microprocessor technologies for use in portable monitoring devices, today announced its first commercial shipments of its recently announced professional pulse oximeters; the PulseOx 6000(TM) and PulseOx 6100(TM)... [PDF] SPO Medical's Press Release -

MicroDose Technologies : Global License to Merck & Co., Inc., for Use of the MicroDose Inhaler with Merck's Proprietary Products

March 3, 2008 - MicroDose TechnologiesInc. (MicroDose) announced that it has entered into a global license agreement with Merck & Co., Inc., through an affiliate, for use of MicroDose's proprietary dry powder inhaler (DPI) with Merck compounds. This agreement follows the successful completion of an exploratory study evaluating the MicroDose DPI technology.... [PDF]MicroDose Technologies' Press Release -

Mpex Pharmaceuticals : MP-376, Granted U.S. Orphan Drug Status for the Treatment of Cystic Fibrosis

March 4, 2008 – Mpex Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Mpex orphan drug designation for levofloxacin solution for inhalation for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. Levofloxacin is the active pharmaceutical ingredient in MP-376, the company’s proprietary levofloxacin solution for inhalation.

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa. Chronic pulmonary infections are difficult to eradicate and are implicated as the major cause of deterioration of pulmonary function and associated morbidity and mortality in CF patients. Chronic infection is associated with pulmonary exacerbations due to bacterial overgrowth, and a decrease in lung function over time from inflammation triggered by bacteria and their toxins... Mpex Pharmaceuticals' Press Release -

Arriva Pharmaceuticals : Phase 2b Development of Lead Inhaled Protein rAAT Replacement Therapy for Hereditary Emphysema

Feb. 28, 2008 - Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti- inflammatory therapies for treating respiratory diseases, completed a financing of 6 million USD led by new Investor Nordic Biotech II K/S and with participation by MPM BioVentures. Since its founding in 1997, Arriva has now raised a total of 81 million USD.
"Key financing from Nordic Biotech II KS and from our earlier lead investor, MPM Capital, allows us to continue the development of recombinant alpha-one antitrypsin for hereditary emphysema," said Sue Preston, CEO, Arriva Pharmaceuticals. "With a committed, experienced management team, we are now focused on the clinical development of our lead and pipeline products."... [PDF]Arriva Pharmaceuticals' Press Release -

Cell Therapeutics : European Marketing Authorization Application for XYOTAX

March 4, 2008- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) who have ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The application is based on a positive opinion CTI received from the EMEA's Scientific Advice Working Party, which agreed to review the application based on the existing results of the phase III clinical trials of XYOTAX, known as the STELLAR trials... Cell Therapeutics' Press Release -

Allegro Diagnostics : to Develop and Commercialize Lung Cancer Molecular Diagnostics Based on Gene Expression

March 7, 2008 - Allegro Diagnostics, a leader in the field of molecular diagnostics for lung cancer, has announced completion of $4 million in Series A financing. Kodiak Venture Partners led the round and was joined by Catalyst Health Ventures and Boston University. Allegro Diagnostics will develop and commercialize products based on gene expression technology developed by Jerome Brody, MD and Avrum Spira, MD, MSc within the Pulmonary Center at the Boston University School of Medicine. Jerome Brody, MD, formerly head of the Pulmonary Center, has joined Allegro Diagnostics as the company's Chief Scientific Officer.

"We are truly fortunate to have a team with world class science and financial backing from outstanding venture partners," said Dan Rippy, President and CEO of Allegro Diagnostics. "The Series A financing will enable us to take our first product, based on intellectual property developed at the Boston University School of Medicine, into the clinic to provide earlier, more accurate diagnosis of suspected lung cancer for patients and their doctors. The clinical community considers earlier identification of lung cancer a major unmet need in treating the disease, so our diagnostic should provide significant benefit."... Allegro Diagnostics' Press Release -

AstraZeneca : Long-Term SYMBICORT® Use In Children With Persistent Asthma

March 17, 2008 – A new study analyzed long-term use of the maintenance combination asthma therapy, SYMBICORT® (budesonide/formoterol fumarate dihydrate), in treating persistent asthma in children 6 to 11 years old. The study examined the safety of SYMBICORT in children for 26 weeks and also included efficacy measures. For children previously treated with inhaled corticosteroid, either alone or in combination, the study showed that long-term treatment with SYMBICORT resulted in significantly greater improvements in lung function and reduced healthcare resource utilization, compared with budesonide dry powder inhaler (DPI) alone. In the study, SYMBICORT also had a safety profile similar to its monocomponent, budesonide, which is an approved asthma medication for children. Results were presented today at the American Academy of Allergy, Asthma & Immunology Annual Meeting held in Philadelphia, March 14-18, 2008... AstraZeneca's Press Release -

Apieron : FDA Clearance of the Insight™ eNO System to Assist Physicians with Patient Asthma Management

MARCH 17, 2008 - Apieron, Inc. announced that the Insight eNO system has received clearance to market by the U.S. Food and Drug Administration.

The Insight eNO system measures exhaled nitric oxide (eNO) which is a well established indicator of airway inflammation and asthma control. The Insight system is a highly accurate device, expressly designed for the physician’s office. It is non-invasive, safe, easy to use, and provides results in less than a minute. Apieron’s unique biosensor detects trace amounts of nitric oxide molecules in a single human breath utilizing a proprietary technology. Current methods and techniques used to diagnose, monitor and treat asthma are costly, time-consuming and cumbersome. Physician office measurement of eNO is a much awaited breakthrough in medical technology that provides physicians with a reliable tool to measure their patients’ respiratory inflammation better than ever before. Measurement of eNO has also been shown to optimize medication therapy and improve compliance among patients with asthma... Apieron's Press Release -

Genaera : MedImmune Initiation of Phase 2A Trial of Antibody Targeting Interleukin-9 in Patients with Asthma

March 18th, 2008 -- Genaera Corporation (NASDAQ: GENR) reported that development partner, MedImmune, has initiated its fourth phase 2a clinical trial of MEDI-528, an anti-IL-9 monoclonal antibody (MAb) targeting interleukin-9 (IL-9), in patients with asthma. This clinical trial is designed to assess the potential of MEDI-528 in patients with stable asthma and exercise-induced bronchoconstriction. Genaera and MedImmune entered into a research collaboration and licensing agreement for this program in 2001.MedImmune is currently evaluating MEDI-528 in patients with asthma in a series of phase 2 clinical trials. The goal of the current phase 2a trial is to assess the safety and tolerability of multiple fixed escalating doses of MEDI-528 in adult patients with stable asthma and exerciseinduced bronchoconstriction... Genaera's Press Release - MedImmune's Press Release -

MAP Pharmaceuticals : Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate

March 24, 2008 - MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that in a pharmacokinetic clinical trial Unit Dose Budesonide (UDB) demonstrated lower systemic drug exposure when compared to the currently marketed conventional nebulized budesonide. UDB is MAP Pharmaceuticals' proprietary nebulized formulation of budesonide, currently in Phase 3 clinical development, for the potential treatment of pediatric asthma. UDB is designed to be administered more quickly and to provide efficacy at lower doses than conventional nebulized budesonide, which is the current leading treatment for pediatric asthma.

The clinical trial was a randomized, open label, cross-over study evaluating the pharmacokinetic profile of two doses of UDB given twice daily in 32 adults with mild to moderate asthma. A 0.135 mg dose of UDB was compared as an alternative to a 0.25 mg dose of conventional nebulized budesonide given twice daily, and a 0.25 mg dose of UDB was compared as an alternative to a 0.5 mg dose of conventional nebulized budesonide given twice daily... MAP Pharmaceuticals ' Press Release -

GlobeImmune, Initiation of a Phase 2a Clinical Trial of GI-4000 in Patients with Non-Small Cell Lung Cancer

March 19, 2008 - GlobeImmune, Inc. announced the initiation of a Phase 2a clinical trial at Memorial Sloan Kettering Cancer Center (MSKCC) to evaluate GlobeImmune’s GI-4000 Tarmogen® for the treatment of non-small cell lung cancer (NSCLC) patients with tumors having mutations in the ras gene.
Molecular profiling of NSCLC tumors :
“NSCLC patients with tumors positive for mutated ras have a worse survival compared to patients with other NSCLC types in the setting of traditional therapy," said Dr. Christopher G. Azzoli, Principal Investigator for the Phase 2a study at MSKCC. "Furthermore, these patients may not benefit from treatment with selective tyrosine kinase inhibitors. Better treatments for lung cancer with mutated ras are greatly needed... GlobeImmune's Press Release -

Tongjitang to Enhance Product Portfolio with a Leading Pulmonary Disease Treatment in China

March 20, 2008 -Tongjitang Chinese Medicines Company (NYSE: TCM) , a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that it has signed a definitive purchase agreement to acquire Qinghai Pulante Pharmaceutical Co. Ltd. ("Pulante"), a privately owned plant-based pharmaceutical company...
...Pulante is located in Xining in the Qinghai province of China and was founded in 2000. It develops, manufactures, markets, and distributes SFDA-approved Tibetan recipe-originated medicines in China. Pulante’s major revenue-generating product, Chongcao Qingfei Capsules, is an OTC product which alleviates the symptoms of respiratory diseases, and targets patients with Chronic Obstructive Pulmonary Disease ("COPD"), a common disease among more than 300 million smokers in China. In 2007, Pulante generated revenue of approximately RMB40 million and was profitable. Pulante’s manufacturing facility in Xining is a GMP-certified manufacturing facility. ... Tongjitang's Press Release -

AlphaMed Pharmaceuticals has successfully expressed a humanized version of the therapeutic protein alpha 1- antitrypsin (AAT)

March 6, 2008 - AlphaMed Pharmaceuticals Corporation announced that the Company has successfully expressed a humanized version of the therapeutic protein alpha 1- antitrypsin (AAT). AlphaMed scientists expressed their recombinant AAT utilizing the Company’s proprietary production system in yeast. The yeast has been genetically altered to produce a molecule “virtually identical” to that which is manufactured by the human body.
“This marks a major milestone for this company and AAT research” stated Joseph McGuirl, AlphaMed’s CEO, “AlphaMed is the first company to develop an AAT molecule with glycosylation that resembles the human protein that is naturally secreted from the liver. The Company has begun to develop products to treat a variety of diseases including hereditary emphysema, COPD, asthma and cystic fibrosis.” Joseph McGuirl joined AlphaMed in July, 2007 and is the former Head of Licensing and Development for Hoffmann- LaRoche... AlphaMed Pharmaceuticals' Press Release -

Universal Detection Technology , Anti-Microbial Product Line Designed to Eliminate MRSA

February 26, 2008 - Universal Detection Technology (OTCBB: UDTT ), (Frankfurt:PO8.F ), a developer of early-warning monitoring technologies to protect people from bioterrorism and other infectious health threats and provider of counter-terrorism consulting and training services, commented on the recent report of a fatality caused by Methicillin-resistant Staphylococcus (MRSA) induced pneumonia of a student in Western Washington University. UDT recently launched a new hub for online sales and marketing of anti microbial products that eliminate harmful bacteria such as MRSA.
The 20 year old student was admitted to the intensive care unit at St. Joseph Hospital in Washington on February 14th after experiencing two weeks of coughing that progressed to fever, vomiting and coughing up blood. Doctors gave him antibiotics, but they were unable to help the young man, who eventually died.
Pneumonia caused by MRSA is a recent phenomenon, only being recognized as a confirmed strain 5 years ago. Adding to this growing concern is the fact that over the last number of years, the MRSA bug has been moving out of nursing home and hospital settings and into public places such as schools. This is the second reported death of a student from MRSA in the last year. MRSA is responsible for more than 94,000 serious infections and nearly 19,000 deaths each year... Universal Detection Technology's Press Release -

ArQule, Phase 1/2 Clinical Trial Program of ARQ 197 in Non-Small Cell Lung Cancer

March 13, 2008--ArQule, Inc. (NASDAQ: ARQL) announced the commencement of patient dosing in a Phase 1/2 clinical trial program of ARQ 197 administered in combination with erlotinib in patients with advanced non-small cell lung cancer (NSCLC). ARQ 197 is an orally available, small molecule inhibitor of the c-Met receptor tyrosine kinase. Erlotinib, marketed as Tarceva(R), is an inhibitor of the EGFR (epidermal growth factor receptor) tyrosine kinase... ArQule's Press Release -

Novelos Therapeutics, Pivotal Phase 3 Lung Cancer Trial

March 13, 2008 - -Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos has reached the target enrollment of 840 patients in the pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy... [PDF] Novelos' Press Release -

Abbott, Genentech, Roche and OSI, Collaboration on Molecular Test for Lung Cancer Therapy Response

March 7, 2008 -Abbott's FISH Technology Provides Analytical Tool with Potential to Assess Clinical Response to Lung Cancer Treatment in Patients with Non-Small-Cell Lung Cancer - Abbott (NYSE: ABT) announced that its molecular diagnostics business has entered into an agreement with Genentech, Inc., F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals, Inc. to develop a gene test to potentially assess the clinical benefit of Tarceva® (erlotinib), an oral tablet indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Under the agreement, Abbott will develop a test to detect extra copies of the epidermal growth factor receptor (EGFR) gene using its proprietary fluorescence in situ hybridization (FISH) technology in NSCLC... Abbott's Press Release -

Luminex and Abbott, Agreement for Global Distribution of the xTAG Respiratory Viral Panel

02/28/08 - Luminex Molecular Diagnostics, a division of Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexing solutions, has signed a global sales and distribution agreement with Abbott's (NYSE: ABT) molecular diagnostics business. Under the terms of the agreement, Abbott will have exclusive rights to distribute Luminex's new xTAGTM Respiratory Viral Panel (RVP) worldwide outside the United States and semi-exclusive rights in the United States.

Based on Luminex's xMAP® multiplexing technology, xTAG RVP was created by Luminex Molecular Diagnostics, in partnership with a team of leading virologists and infectious disease specialists. In a matter of hours from a single patient sample, the test allows doctors to detect the presence or absence of several viruses and subtypes at once... Luminex's Press Release -

Quidel's QuickVue RSV Test : FDA Grants CLIA Waiver

Feb. 29, 2008--Quidel Corporation (NASDAQ:QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, announced that the U.S. Food and Drug Administration (FDA) granted CLIA waiver for the QuickVue(R) RSV test for the qualitative detection of respiratory syncytial virus (RSV). The waiver makes the QuickVue RSV test more widely available for use, especially in physician offices and clinics where waived tests are used most frequently. The QuickVue RSV test is simple and accurate, with high sensitivity and specificity.

Respiratory syncytial virus is recognized by the American Academy of Pediatrics as the leading cause of pneumonia and bronchiolitis among children two years of age and younger. RSV is a common virus with symptoms that often resemble the common cold.(1) The QuickVue RSV test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients... Quidel's Press Release -

Altor BioScience , Tissue Factor Antagonists from Genentech

February 12, 2008 - Altor BioScience Corporation (Altor) announced it has entered into an agreement with Genentech, Inc. for exclusive, worldwide rights to develop and commercialize a class of antibody-based Tissue Factor antagonists. Altor plans on initiating a multi-center, Phase II clinical study later this year, using the lead therapeutic antibody known as ALT-836 for the treatment of Acute Respiratory Distress Syndrome (ARDS) and Acute Lung Injury (ALI)... Altor BioScience's Press Release -

Introgen's p53 Immunotherapy INGN 225 in Patients with Small Cell Lung Cancer

Feb. 13, 2008--Introgen Therapeutics, Inc. (NASDAQ:INGN) and Moffitt Cancer Center today announced that a randomized, controlled study of INGN 225, Introgen's immunotherapy product has been initiated in patients with metastatic small-cell lung cancer (termed extensive stage SCLC).

Introgen and Moffitt previously announced that the National Institutes of Health National Cancer Institute awarded a grant of approximately $1.3 million to fund the trial based upon the promising results of previous clinical studies in small-cell lung cancer patients.
INGN 225 is a p53 immunotherapy using a patient's own cells to stimulate an anti-tumor immune response to fight cancer. The immunotherapeutic targets the p53 tumor suppressor molecular abnormality found in over half of all solid cancers... Introgen's Press Release -

Inspire, Second Phase 3 Cystic Fibrosis Trial

Feb 13, 2008 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the initiation of TIGER-2, its second pivotal Phase 3 clinical trial with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF).

TIGER-2 (Transport of Ions to Generate Epithelial Rehydration) is a 24-week, double-blind, placebo-controlled, randomized study comparing 60 mg of denufosol inhaled three times daily to placebo in approximately 350 CF patients with FEV1 (Forced Expiratory Volume in one second) greater than or equal to 75% of predicted normal. The trial's primary efficacy endpoint is change from baseline in FEV1 (liters) at the 24-week timepoint. Secondary endpoints include other lung function parameters, pulmonary exacerbations, requirements for concomitant CF medications and quality of life... Inspire's Press Release -

Expression Pathology, Research in Identifying Biomarkers of Lung Cancer Metastasis and Survival

February 19, 2008 - Expression Pathology Inc. (EPI), a leader in tissue proteomics, announced that researchers at Tokyo Medical University, using the company’s tissue microproteomics technologies, identified protein biomarkers associated with lung cancer metastasis, which were further studied for correlation to clinical outcomes. The researchers used EPI’s Liquid Tissue® reagents and Director™ laser microdissection slides to analyze formalin-fixed paraffin-embedded (FFPE) tissue samples by mass spectrometry... [PDF] Expression Pathology's Press Release -

Biothera’s Imprime PGG with Avastin Against Cancer

February 28, 2008 – Biothera’s Imprime PGG™ increased the effectiveness of Avastin® (bevacizumab), a monoclonal antibody approved for the treatment of metastatic colorectal, breast and non-small cell lung cancer, according to a new preclinical study published in the current issue of Clinical Cancer Research.

Researchers in the Tumor Immunobiology Program of the James Graham Brown Cancer Center, University of Louisville, Kentucky, studied the synergistic effects of Imprime PGG in combination with Avastin in a xenograft mouse model where human ovarian cancer cells were implanted into the mice. In the treatment group receiving both Imprime PGG and Avastin, 86% of the mice survived 100 days compared with only 43% in the group receiving Avastin alone... Biothera 's Press Release -

Response Genetics, ResponseDX Tests to Select Institutions

March 5, 2008 - Response Genetics, Inc. (NASDAQ: RGDX) announced that its ResponseDX: Lung™ and ResponseDX: Colon™ tests are now available to select medical institutions and practice groups through its CLIA-registered laboratory. ResponseDX: Lung™ and ResponseDX: Colon™ are PCR-based tests that help guide therapeutic treatment decisions in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The tests are in their initial launch phase and are available only to pre-qualified institutions at this time... Response Genetics' Press Release -

Gilead, Aztreonam Lysine 75 mg Powder for Nebuliser Solution, a Potential New Treatment for Cystic Fibrosis

Mar 07, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) announced the submission of a Marketing Authorisation Application (MAA) for marketing approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency (EMEA). Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow(R) Nebuliser (PARI GmbH)... Gilead Sciences' Press Release -

Alnylam, First Human Proof of Concept for an RNAi Therapeutic with GEMINI Study

Feb 29, 2008 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced that it has achieved human proof of concept with an RNAi therapeutic, a first for the industry. Results from the company's GEMINI trial with ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV), showed statistically significant anti-viral efficacy. In the Phase II experimental infection study, treatment with ALN-RSV01 led to a decreased RSV infection rate, an increase in the number of subjects who remained free of infection, and was safe and well tolerated. Results from GEMINI are being presented at the International Symposium on Respiratory Viral Infections in Singapore... Alnylam's Press Release -

Aerocrine, NIOX MINO: a New Hand-Held Device to Measure Airway Inflammation in Asthma

4 March, 2008 - NIOX MINO® Set to Dramatically Improve Airway Inflammatory Disease Management through Personalized Inflammation Control.
Aerocrine, Inc. (STO:AEROB) announced that NIOX MINO, a hand-held point-of-care device for the measurement of airway inflammation, has been 510(k) cleared by the U.S. Food and Drug Administration (FDA). Physicians in the U.S. now have a highly accurate, non-invasive and convenient technology that is appropriate for use in a doctor’s office, ultimately helping them improve how they treat asthma patients.NIOX MINO provides accurate, reproducible and immediate measurement of fractional exhaled nitric oxide (FENO), a validated method for assessing asthma-related airway inflammation. NIOX MINO is the first hand-held device to measure airway inflammation—an underlying cause of inflammatory airway diseases—helping physicians improve patient outcomes and reduce healthcare expenditures... [PDF] Aerocrine's Press Release -