SkyePharma : exclusive License Agreement with Kyorin for Development and Distribution of Flutiform in Japan

22 April, 2008 - SkyePharma PLC (LSE: SKP) announces that it has entered into an exclusive Development, Distribution and License Agreement for Flutiform(TM), its lead development product for the treatment of asthma, with Kyorin Pharmaceutical Co., Ltd., a subsidiary of Kyorin Co., Ltd. for Japan. SkyePharma will receive signing, development and approval milestones worth several millions of pounds plus a high mid-single digit royalty on sales.The development costs associated with obtaining approval for the Japanese market will largely be met by Kyorin, which is responsible for clinical trials and regulatory submissions. Development is expected to take several years... SkyePharma's Press Release -

eResearchTechnology, Inc. and nSpire Health, Inc. : Alliance to Deliver Integrated Cardiac Safety and Pulmonary Trial Services

April 14, 2008 - eResearchTechnology, Inc. (eRT), (Nasdaq: ERES), and nSpire Health, Inc. announced today their alliance to provide integrated Cardiac Safety and Pulmonary Core Lab Services to clinical researchers worldwide.
eResearchTechnology is a leading provider of centralized electrocardiographic (ECG), eClinical technology, ePRO, and other services to the pharmaceutical, biotechnology, medical device, and related industries.

nSpire Health is a leading provider of respiratory clinical trials services, including Cardiopulmonary Exercise Testing, High Definition Pulmonary Diagnostics Systems, Spirometry, and Home Monitoring... nSpire Health's Press - eResearchTechnology's Press release -

Alnylam : ALN-RSV01 in Adult Lung Transplant Patients Naturally Infected with Respiratory Syncytial Virus (RSV) Infection

April 9, 2008- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced it has initiated a Phase II clinical trial to assess the safety and tolerability of aerosolized ALN-RSV01 versus placebo in adult lung transplant patients naturally infected with RSV. As a secondary objective, this trial will be the first to evaluate the anti-viral activity of ALN-RSV01 in a naturally acquired RSV lower respiratory tract infection... Alnylam's Press Release -

Critical Therapeutics : Phase I Clinical Trial of the R(+) Isomer of Zileuton

April 8, 2008- Critical Therapeutics, Inc. (Nasdaq: CRTX) announced the results of its 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 CR(TM) (zileuton) extended-release tablets... Critical Therapeutics' Press Release -

bioMerieux & University of Sunderland : Collaboration in New Research Significantly Improving the Identification of Pseudomonas aeruginosa

April 3, 2008 . A team of researchers from the University of Sunderland and bioMérieux, a leading company in the field of in vitro diagnostics, have achieved a new step in the fight against Pseudomonas aeruginosa, a bacterium responsible for deadly healthcare-associated infections, which kills tens of thousands of people throughout the world every year .

Researchers at the University of Sunderland’s Pharmacy School, Professor Paul Groundwater and Dr. Roz Anderson, in collaboration with Prof. John Perry of Freeman Hospital in Newcastle, Prof. Arthur James of Northumbria University and Sylvain Orenga of bioMérieux have discovered a new technique for the highly specific detection of Pseudomonas aeruginosa, which primarily infects the lungs of patients with cystic fibrosis. It is also a major cause of infection among patients with immune deficiencies, such as patients with AIDS and cancer or those suffering from burns... bioMérieux's Press Release -

TaiGen : Positive Data From the Phase II Study of Nemonoxacin (TG-873870) in Community-Acquired Pneumonia

2008/04/07 - -TaiGen Biotechnology Co., Ltd. announced today that the nemonoxacin phase II top-line data in community-acquired pneumonia (CAP) met the primary endpoint of non-inferiority versus levofloxacin, the leading quinolone on the market. Nemonoxacin is a novel non-fluorinated quinolone that has a broad spectrum of activity against gram-positive and gram-negative bacteria and atypical pathogens. Importantly, nemonoxacin possesses the first-in-class activity against MRSA (both hospital- and community-acquired) and vancomycin-resistant pathogens... TaiGen Biotechnology's Press Release -

Aeolus Pharmaceuticals : AEOL 10150 Protects Lungs from Fractionated Radiation

April 15, 2008 -Aeolus Pharmaceuticals, Inc. (OTCBB: AOLS) reported data published in the peer-reviewed journal, Free Radical Research, show the Company’s lead compound, AEOL 10150, provided statistically significant protection of the lungs of Fisher 344 rats exposed to fractionated radiation in a study led by Zeljko Vujaskovic, M.D. Ph.D. of Duke University. The study also demonstrated that the compound reduced markers for tissue hypoxia, angiogenesis, inflammation and oxidative stress in rats studied in this experiment.

The primary objective of this study was to determine whether administration of AEOL 10150 reduces the severity of long-term lung injury induced by fractionated radiation.. [PDF] Aeolus Pharmaceuticals' Press Release -

AVEO’s Novel Triple VEGF Receptor Inhibitor... Clinical Activity and Tolerability in other Solid Tumors including Colon and Lung Cancers

April 14, 2008 – AVEO Pharmaceuticals, Inc., a biotechnology company leveraging breakthrough discoveries in cancer biology to discover, develop and commercialize targeted oncology therapies, today announced that their novel oral triple VEGF receptor inhibitor AV-951 shows clinical activity in multiple advanced solid tumor types including renal, colon and lung cancers and is well tolerated according to new data from the expanded Phase 1 clinical trial of the company’s lead product candidate. Partial response or stable disease was observed across all patients with renal cell carcinoma, and overall, one-third of patients across all tumor types achieved tumor shrinkage during treatment with AV-951... AVEO Pharmaceuticals' Press Release -

Idera Pharmaceuticals : Preclinical Data of its Toll-Like Receptor - Targeted Compounds at AACR Meeting

Apr 09, 2008 - Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced that preclinical data from its Toll-Like Receptor (TLR) programs will be presented at the 2008 Annual Meeting of the American Association for Cancer Research (AACR) being held in San Diego, CA, April 12-16, 2008...
... Abstract 2078 entitled "Antitumor activity of IMO-2055, an agonist of TLR9, in combination with erlotinib and bevacizumab in non-small cell lung cancer xenografts in mice" will be presented by Idera. In the study, IMO-2055, a TLR9 agonist, was evaluated in combination with erlotinib and bevacizumab in preclinical mice models... Idera Pharmaceuticals' Press Release -

Kamada : New Orphan Drug Designation by the FDA, for its Aerosolized AAT for the treatment of Bronchiectasis

April 8th, 2008 - Kamada, a biopharmaceutical company which develops, manufactures and markets specialty life-saving therapeutics, announces today that the company was granted an Orphan Drug Designation to its Aerosolized Alpha-1 Antitrypsin (AAT) product to treat Bronchiectasis.
Kamada's aerosolized AAT product for treating Bronchiectasis, a lung disease that results in the distortion of one or more of the conducting bronchi or airways, is currently undergoing Phase II clinical trials... Kamada's Press Release -

Yale and Asuragen : a microRNA Can Reduce Lung Cancer Growth

March 25, 2008 - -A microRNA (miRNA) molecule known as let-7 substantially reduced cancer growth in multiple mouse models of lung cancer as reported by researchers at Yale University School of Medicine and Asuragen, Inc. in the journal Cell Cycle.

Cancer afflicts 1.5 million people a year in the United States alone, and lung cancer is the most common and deadly form of cancer worldwide. This study indicates a direct role for a miRNA in cancer progression and introduces a new therapeutic paradigm that features the treatment of cancer with a naturally occurring small RNA... [PDF] Asuragen's Press Release - [PDF] Mirna Therapeutic's Press Release -

Aradigm : Trial of Lung Rx's Inhaled Treprostinil

April 8, 2008--Aradigm Corporation (OTCBB: ARDM) announced it initiated a bridging clinical trial of inhaled treprostinil utilizing its AERx Essence(R) pulmonary delivery system. The trial in healthy volunteers is being conducted in the United Kingdom to evaluate aerosol delivery by assessing lung distribution, pharmacokinetics and safety of inhaled treprostinil delivered by the AERx Essence system versus delivery with the Nebu-Tec OPTINEB*-ir nebulizer.
The latter device was used by Lung Rx, Inc. (Lung Rx), a wholly owned subsidiary of United Therapeutics Corporation, in the recently concluded TRIUMPH (TReprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension) study of inhaled treprostinil in patients with Pulmonary Arterial Hypertension (PAH)... Aradigm's Press Release -

KaloBios : Phase 1/2 Trial of Humaneered Monoclonal Antibody KB001 for Treatment of Pseudomonas Infections in Cystic Fibrosis Patients

March 31, 2008 – KaloBios Pharmaceuticals, Inc., a privately held biopharmaceutical company, announced the initiation of a Phase 1/2 clinical trial of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of P. aeruginosa infections. The trial is being conducted in conjunction with the Cystic Fibrosis Foundation and its affiliated organizations.
The blinded, placebo-controlled trial, which is being conducted at over 10 sites across the United States, will enroll up to 48 patients with cystic fibrosis who will receive either one of two dose levels of KB001 or placebo. Endpoints for the trial include safety, reduction of P. aeruginosa bacteria, and inflammatory markers... KaloBios' Press Release -

Kamada : Phase III Clinical Trial with Intravenous AAT

April 02, 2008 - Kamada, a biopharmaceutical company developing, producing and marketing a line of specialty, life-saving therapeutics, announced that it has successfully met the primary endpoint in the Phase III US clinical trials with its intravenous Alpha-1 Antitrypsin (AAT). The product is used to treat hereditary AAT deficiency which leads to Congenital Emphysema... Kamada's Press Release -