October 24, 2007 — Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for its first-in-class antibiotic Tygacil® (tigecycline) for the treatment of patients with community-acquired pneumonia (CAP)... 
October 16, 2007 – Tomophase Corporation announced that it will display the first cross-sectional images of excised human bronchial tissue using their proprietary optical coherence tomography (“OCT”) system at the CHEST meeting in Chicago, October 22nd through October 24th... The Tomophase OCT System enables the interventional pulmonologist to clearly visualize sub-epithelial tissue structures in the airway. The system, which is not yet FDA-approved, utilizes a near-infrared emitting probe in a catheter which is integrated with a conventional video bronchoscope... Tomophase' Press Release-
Oct 17, 2007 - Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced that its lead product candidate, picoplatin, has been granted orphan medicinal product* designation for the treatment of small cell lung cancer (SCLC) by the European Commission. This designation is based on a recommendation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA)... Poniard Pharmaceuticals' Press Release-
Oct. 17 , 2007 - Pharmion Corporation (Nasdaq: PHRM) announced the initiation of an international pivotal Phase 3 clinical trial evaluating amrubicin, the Company's third-generation synthetic anthracycline, in the treatment of second-line small cell lung cancer (SCLC). The randomized, controlled, multi-center study will compare amrubicin to topotecan, the only approved chemotherapy for second-line treatment of SCLC in the US and EU. Enrollment in the study of 480 patients is underway... Pharmion's Press Release-
October 16, 2007 - Dey, L.P. , a subsidiary of Mylan Inc. (NYSE: MYL), announces three clinical data presentations will be given at CHEST 2007, the annual scientific assembly of the American College of Chest Physicians (ACCP) on Wednesday, October 24, 2007 at the McCormick Place Convention Center in Chicago. Data will be presented from two safety studies that were included as part of the New Drug Application (NDA) filing to the U.S. Food and Drug Administration (FDA) for Perforomist™ Inhalation Solution. The third presents results from a Phase IIIb study of the concomitant use of Perforomist™ Inhalation Solution with tiotropium for the treatment of COPD... Dey's Press Release-
Oct 16, 2007 - Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Thomas, McNerney & Partners, LLC, announced that Altair Therapeutics Inc., a new venture capital-funded biotechnology company, has been created to focus on the discovery, development and commercialization of Isis' antisense drugs to treat asthma and other respiratory conditions. Isis has granted an exclusive worldwide license to Altair for the development and commercialization of ISIS 369645, an inhaled inhibitor of the IL-4/IL-13 signaling pathways for the treatment of asthma... Isis' Press Release-
October 15, 2007 - Telik, Inc. (Nasdaq: TELK) announced that the U.S. Food and Drug Administration (FDA) has removed the partial hold on TELCYTA®(canfosfamide HCl, TLK286) clinical trials. This action follows a complete review of TELCYTA data by the agency and permits the resumption of TELCYTA clinical development...TELCYTA, a tumor-activated small molecule product candidate in clinical development for the treatment of advanced ovarian cancer and non-small cell lung cancer... Telik' Press Release-
Oct 15, 2007 - Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process on the Phase III trial design of the company's pivotal study with ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) for the treatment of non-small cell lung cancer in the first-line setting... Abraxis BioScience's Press Release-
Oct. 15, 2007- Critical Therapeutics (Nasdaq: CRTX) announced the start of patient enrollment in the LEUKO study, a randomized, double-blind, placebo-controlled efficacy trial to examine the effects of ZYFLO(R) (zileuton tablets) used in the treatment of adults with Chronic Obstructive Pulmonary Disease (COPD). The purpose of this trial is to examine the effectiveness of ZYFLO at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or a worsening of their COPD symptoms... Critical Therapeutics' Press Release-
October 12, 2007 - Physicians & TB controllers around the country can now quickly and accurately detect M. tuberculosis infection with today's U.S. Food and Drug Administration (FDA) approval of QuantiFERON(R)-TB Gold In-Tube (QFT(TM)). This blood test detects cellular immune responses to proteins specifically associated with tuberculosis (TB) infection... Cellectis' Press Release [PDF]-
Calif., Oct 11, 2007 - Threshold Pharmaceuticals, Inc. (Nasdaq: THLD) announced that, as part of a planned interim analysis, it would stop enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of glufosfamide in patients with recurrent, sensitive small cell lung cancer... Threshold Pharmaceuticals' Press Release-
October 11, 2007 - Oridion Systems, Ltd. - (SWX: ORIDN) introduces Smart Capnography(TM), a major step forward in improving patient safety. This new launch takes place at this week's American Society of Anesthesiologists in San Francisco, CA. Smart Capnography combines Oridion's most advanced Microstream(R) technology with its new SARA(TM) software for improved alarm management... Oridion's Press Release [PDF]-
October 10, 2007 – Proteolix, Inc. and South Texas Accelerated Research Therapeutics (START) announced the enrollment of the first patient in a Phase 1 clinical trial to study Proteolix’s investigational drug, carfilzomib (PR-171)....
Oct 10, 2007 - Nektar Therapeutics (Nasdaq: NKTR) announced that preclinical data for its proprietary product candidate NKTR-102 (PEG-irinotecan) will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Therapeutics in San Francisco, California on October 25, 2007. The presentations will highlight new results from preclinical trials of NKTR-102 in mouse models of colorectal, lung and breast cancers... Nektar's Press Release-
October 9, 2007 - Broncus Technologies, Inc., a medical device company investigating the airway bypass procedure for the treatment of emphysema, announced that the results of its open-label Exhale® Drug-Eluting Stent feasibility study have been published in the October issue of the Journal of Thoracic and Cardiovascular Surgery. Positive results include a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure... Broncus' Press Release-
respectively, will be presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, which will be held October 22-26, 2007 in San Fran cisco... Exelixis' Press Release -
Oct 9, 2007 - MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), announced positive results from a Phase IIa clinical study of MN-221, its novel intravenous product candidate for the treatment of status asthmaticus* (acute severe asthma attack)... MediciNova's Press Release -
October 5, 2007 - PTC Therapeutics, Inc. (PTC), a biopharmaceutical company focused on the discovery, development and commercialization of small-molecule drugs targeting post-transcriptional control mechanisms, today announced encouraging data from a Phase 2 clinical trial of PTC124 in pediatric patients with cystic fibrosis (CF) due to a nonsense mutation... PTC Therapeutics' Press Release -
Oct. 4, 2007--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced that it has completed patient enrollment in TIGER-1, the first of two planned pivotal Phase 3 clinical trials with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis*(CF)... Inspire's Press Release -
Oct. 4 /PRNewswire/ -- MedImmune, Inc. announced results from two important studies presented at the 2007 Infectious Diseases Society of America (IDSA) 45th Annual Meeting adding to the body of knowledge about respiratory syncytial virus* (RSV). RSV is a viral pathogen that produces annual outbreaks usually between fall and spring. While RSV typically manifests cold-like symptoms in healthy children, it can prove to be a very serious respiratory illness for premature infants and is the leading cause of respiratory infections for newborns each year... MedImmune 's Press Release -
Oct. 4, 2007--Gilead Sciences, Inc. (Nasdaq:GILD) announced detailed results of its Phase III AIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation, an investigational therapy in development for the treatment of people with cystic fibrosis* (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). In this study, a 28-day treatment course of aztreonam lysine improved respiratory symptoms as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome (PRO) tool. Aztreonam lysine also improved pulmonary function in this study, as measured by relative improvement of forced expiratory volume in one second (FEV1), a standard measure of lung function... Gilead's Press Release -
October 02, 2007 - -At Medtrade 2007, Invacare Corporation (NYSE:IVC) will be launching a series of products and programs that will help providers remain profitable in the new home medical equipment (HME) environment... The Invacare Respiratory Division will introduce the new Invacare® XPO2™ extremely portable oxygen concentrator. The XPO2 is the latest introduction to Invacare's proven line of innovative home oxygen technologies... Invacare's Press Release -
October 1, 2007 - Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, announced that Novelos, in collaboration with the Medical University of South Carolina (MUSC), was awarded a $150,000 competitive grant by the National Institutes of Health (NIH) under Phase I of the Small Business Technology Transfer (STTR) program. This grant will support further scientific development of NOV-002, Novelos' lead compound in pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track... Novelos' Press Release [PDF] -
October 1, 2007 - Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the initiation of a Phase I clinical trial to assess the safety and tolerability of an oral single dose of the R(+) isomer of zileuton in healthy subjects. R(+) zileuton combined in equal proportion with its mirror image isomer, S(-) zileuton, comprise racemic zileuton, which is the pharmaceutical ingredient in ZYFLO® (zileuton tablets) and ZYFLO CR(TM) (zileuton) extended-release tablets...In addition to asthma, the successful development of the R(+) isomer may also allow for possible development opportunities in other diseases - such as Chronic Obstructive Pulmonary Disease.. Critical Therapeutics' Press Release -
Oct. 1, 2007 - Emphasys Medical Inc. announced the submission of a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) requesting regulatory approval to market the Emphasys endobronchial valve, the Zephyr(R) EBV, in the United States. The Zephyr EBV is a minimally invasive and potentially reversible treatment option intended to help patients with emphysema breathe easier...Emphasys Medical's Press Release -
Oct. 1, 2007 , 2007 - Discovery Laboratories, Inc. (NasdaqGM:DSCO) today announces that its new Surfaxin(r) (lucinactant) process validation batches have demonstrated acceptable stability at six months under Discovery Labs' comprehensive stability testing protocol. This six-month stability data will be included, along with other data and information, in a formal response to the U.S. Food and Drug Administrations' (FDA) April 2006 Approvable Letter for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants... Discovery Laboratories' Press Release [PDF] -
Oct. 1 , 2007 - FASgen's fatty acid synthase inhibitor (FASi) compounds, led by FAS031, have demonstrated efficacy against every solid tumor xenograft cell line tested, in both orthotopic and flank models: 4 lung tumor cell lines (H460; A549; H1975; LX7); two ovarian; breast; and, colon. In many cases the tumors were eradicated entirely. The compounds have been shown in extensive preclinical studies to be remarkably safe and orally available... FASgen's Press Release -
