AstraZeneca RECENTIN BR24 Non-Small Cell Lung Cancer Trial Will Not Progress

27 February 2008 - ... AstraZeneca also announced that the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of RECENTIN at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study’s Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III... AstraZeneca's Press Release -

Aerocrine, Chest M.I. market and sell NIOX MINO in Japan

February 11, 2008 – Aerocrine AB (OMX Nordic Exchange: AERO) announces that the company has entered into a distribution agreement with Chest M.I. Inc. Chest will market and sell NIOX MINO® in Japan.Chest manufactures and sells a large range of products to measure lung function as well oxygen delivery systems for home use.
The company which was founded in 1965 is one of the largest companies in its field with over 50% share of the Japanese market.Chest has an impeccable reputation and impressive market coverage with over 10 local sales offices. Chest will apply for market authorization of NIOX MINO in Japan and then proceed to product launch... [PDF] Aerocrine's Press Release-

N30 Pharma, Successful Initiation of Human Studies with N30-201

Jan. 28, 2008 - N30 Pharma (N30), a biopharmaceutical company focused on the discovery, development, and commercialization of respiratory drugs that target endogenous s-nitrosothiols, announced today that it has successfully completed Phase 1 study of N30-201 in healthy volunteers.
N30 intends to develop N30-201 for the treatment of reactive and obstructive airway diseases, including Cystic Fibrosis and asthma... N30 Pharma's Press Release -

Glenmark, USD 15 million as milestone payments from Forest for Oglemilast, GRC 3886

February 06, 2008 – Glenmark Pharmaceuticals Ltd. [Glenmark], announced that its wholly owned Swiss subsidiary Glenmark Pharmaceuticals SA (GSA), has received a milestone of USD 15 Million from Forest Labs, which is Glenmark’s North American partner for Oglemilast (GRC 3886). This follows a favourable response from USFDA, allowing Forest to initiate an additional Phase II study in COPD for Oglemilast. Glenmark and Forest Labs are working together closely to initiate additional studies for further longer term development of Oglemilast, including a Phase II study in Asthma... [PDF] Glenmark Pharmaceuticals' Press Release -

BioMarck Pharmaceuticals, FDA Agreement on its Phase 2 Clinical Trial Plans

Jan. 29, 2008 - BioMarck Pharmaceuticals, a biopharmaceutical research and development company focused on new therapies for the treatment of respiratory diseases, announced that it has obtained agreement from the U.S. Food and Drug Administration (FDA) for its proposed plans for a Phase 2 trial of the novel respiratory drug, BIO-11006 Inhalation Solution.

Phase 1 studies of BIO-11006, an inhaled drug designed to combat the oversecretion of mucus and inflammation in diseases such as chronic obstructive pulmonary disease (COPD), asthma, and cystic fibrosis, were conducted on healthy volunteers and have demonstrated that the treatment is safe and well tolerated... [FLASH] BioMarck's Press Release -

ADVENTRX, Complete ANX-530 Pharmacokinetic Data at the 2008 American Association for Cancer Research Annual Meeting

Feb. 7, 2008 - ADVENTRX Pharmaceuticals, Inc. (Amex: ANX), announced that complete pharmacokinetic data from the Company's marketing-enabling bioequivalence clinical study of ANX-530 (vinorelbine emulsion) has been accepted for presentation at the 2008 American Association for Cancer Research (AACR) Annual Meeting, which takes place April 12 - 16, 2008 in San Diego, CA...
... ANX-530 is designed to reduce the incidence and severity of injection site reactions from intravenous delivery of vinorelbine tartrate. Vinorelbine tartrate works by disrupting microtubule formation and is a member of the vinca alkaloid class of antineoplastic agents. Vinorelbine is indicated as a single agent or in combination with cisplatin for treatment of advanced non-small cell lung cancer and has also shown activity in breast, ovarian, and other cancers...ADVENTRX's press Release-

Hana Biosciences, Top-Line Phase 1 Clinical Trial Data Demonstrating Alocrest to be Well-Tolerated With Promising Anti-Tumor Activity

Calif., Feb. 12, 2008 - Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the company has completed patient enrollment in its Phase 1 dose-escalation clinical trial of Alocrest(tm) (vinorelbine liposomes injection, OPTISOME(tm)). This trial was designed to assess the safety, tolerability and preliminary efficacy of Optisomal encapsulated vinorelbine, or Alocrest...
... Alocrest is a novel sphingomyelin/cholesterol liposome-encapsulated vinorelbine tartrate formulation. Vinorelbine, a semi-synthetic vinca alkaloid, is a microtubule inhibitor that has been approved for use as a single agent or in combination with cisplatin for the first-line treatment of advanced non-small cell lung cancer... Hana Biosciences' Press Release -

Bayer and Onyx , Update on Phase 3 Trial of Nexavar in Patients With Non-Small Cell Lung Cancer

Feb. 18, 2008 - Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that a Phase 3 trial evaluating Nexavar® (sorafenib) tablets in patients with non-small cell lung cancer (NSCLC) was stopped early following a planned interim analysis, when the independent Data Monitoring Committee (DMC) concluded that the study would not meet its primary endpoint of improved overall survival. The Phase 3 ESCAPE (Evaluation of Sorafenib, Carboplatin And Paclitaxel Efficacy in NSCLC) trial evaluated Nexavar when administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC). Safety events were generally consistent with those previously reported. However, higher mortality was observed in the subset of patients with squamous cell carcinoma of the lung treated with sorafenib and carboplatin and paclitaxel versus those treated with carboplatin and paclitaxel alone... Onyx's Press Release- Bayer HealthCare's Press Release-

Oncothyreon's PX-478, effective in preclinical model of human lung cancer

Feb 25, 2008 - Oncothyreon Inc. (Nasdaq - ONTY) (TSX - ONY) (the "Company") announced the presentation of data demonstrating the effectiveness of PX-478 in a preclinical model of human lung cancer at the 8th Annual Targeted Therapies of the Treatment of Lung Cancer meeting of the International Association for the Study of Lung Cancer in Santa Monica, California. The data were presented on February 22, 2008, by Jorg J. Jacoby, Ph.D., Instructor, University of Texas M.D. Anderson Cancer Center, Houston. Oncothyreon's PX-478 is a small molecule inhibitor of hypoxia inducible factor (HIF)-1 alpha currently in a Phase 1 trial in patients with advanced metastatic cancer and lymphoma.
The study employed a model of lung cancer in mice, which closely mimics the disease in humans. Treatment with oral PX-478 for five days resulted in significant inhibition of tumor growth, marked reduction in lymph nodes metastases, decreased volume of pleural effusions, and significantly improved survival. PX-478 was effective in models of both non-small cell lung cancer and small cell lung cancer that express HIF-1 alpha...Oncothyreon's Press Release-

Strativa Pharmaceuticals, Discontinuation of the Development Program for Pafuramidine

February 25, 2008 – Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE:PRX) announced that its development partner, Immtech Pharmaceuticals, Inc. (AMEX: IMM) has chosen to discontinue the development program for pafuramidine maleate, an investigative therapy...
...receiving recommendations from the Data Safety Monitoring Board, the Steering Committee for the pneumocystis pneumonia (PCP) study and others, and in consultation with the US Food and Drug Administration (FDA) and Immtech’s licensing partners, including Strativa, Immtech has chosen to discontinue the development program for pafuramidine... Par Pharmaceutical's Press Release-

VioQuest Pharmaceuticals, Clinical Trial Agreement for Novel Akt Inhibitor VQD-002 with the National Cancer Institute

February 26, 2008 – VioQuest Pharmaceuticals (OTCBB: VQPH) announced that the Company and the U.S. National Cancer Institute (NCI) Center for Cancer Research have entered into a Clinical Trial Agreement (CTA) for the Company’s product candidate VQD-002 (triciribine phosphate monohydrate or TCN-P). VQD-002 is a small molecule anticancer compound that inhibits activation of protein kinase B (PKB or AKT), a key component of the phosphoinosotide-3 kinase (PI3K) signaling pathway known to promote cancer cell growth and survival as well as resistance to chemotherapy and radiotherapy.

The agreement provides for the NCI to sponsor a clinical trial of VQD-002 in combination with erlotinib (Tarceva®), an epidermal growth factor receptor (EGFR) inhibitor. EGFR is overexpressed or amplified in a variety of tumor types and is a major target in the treatment of advanced lung cancer and other solid tumors. Recent reports have shown that the sensitivity of multiple types of solid tumors to EGFR inhibitors is dependent on inhibition of the PI3K pathway, suggesting that VQD-002 might be clinically useful to enhance response to erlotinib...VioQuest Pharmaceuticals' Press Release-

GSK's Volibris (ambrisentan), EMEA positive opinion for approval to treat class II and II pulmonary arterial hypertension (PAH)

Thursday 21st February 2008 - GlaxoSmithKline (GSK) announced that Volibris^® (ambrisentan) has received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the treatment of Pulmonary Arterial Hypertension (PAH) in patients classified as World Health Organisation (WHO) Functional Class II and III, to improve exercise capacity¹. Approval by the European Commission and Marketing Authorisation is expected to be granted by the end of April 2008.
Ambrisentan, a non-sulphonamide class endothelin receptor antagonist (ERA), is the first PAH medicine indicated for WHO Functional Class II patients in Europe...GSK's Press Release-

UCB and sanofi-aventis, FDA Approves XYZAL® (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies

February 19, 2008 - UCB and sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for XYZAL® (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. XYZAL® tablets received FDA approval on May 25, 2007 and both formulations are now approved for use in adults and children 6 years and older...Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies affect as many as 40 million people in the United States... UCB's press Release- [PDF] sanofi-aventis' Press release-

Pfizer and The Pfizer Foundation, to Support Cancer and Tobacco Control around the World

February 19, 2008 -The Pfizer Foundation announced a groundbreaking $33 million multi-year program to address the emerging challenges in cancer and tobacco control. The first round of the Global Health Partnerships grants has already been awarded to 15 non-governmental organizations (NGOs) in 26 countries around the world – from Algeria, China and Japan to Italy, Brazil and Argentina. The program reflects both the Pfizer Foundation and Pfizer’s global commitment to working with a diverse group of local NGO experts towards improving the diagnosis and treatment of cancer and reducing the disease’s incidence and burden.
Cancer accounts for one in eight deaths globally– more than AIDS, tuberculosis and malaria combined. In the 20^th century, the tobacco epidemic killed 100 million people worldwide... Pfizer's Press Release-

GlaxoSmithKline, EMEA positive opinion for the approval of Hycamtin® (topotecan) hard capsules for the treatment of relapsed small cell lung cancer

04 February 2008 - GlaxoSmithKline (GSK) announced that oral Hycamtin^™ (topotecan hard capsules) has received a positive opinion from the European Medicines Agency (EMEA) recommending marketing authorisation. GSK expects final approval by the European Commission and Marketing Authorisation for this indication in approximately two months. Topotecan capsules will be indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate...GlaxoSmithKline's Press Release-

Schering-Plough, ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children 4-11

Feb. 4, 2008 - Schering-Plough Corporation (NYSE: SGP) announced that the U.S. Food and Drug Administration (FDA) has approved ASMANEX (R) TWISTHALER (R) 110 mcg (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age. ASMANEX is an inhaled corticosteroid (ICS). ASMANEX 220 mcg was approved on March 31, 2005 by the FDA for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older... Schering-Plough's Press Release-

MedImmune submitted Biologics License Application to FDA for Motavizumab

Feb. 4 , 2008 - MedImmune announced it submitted to the U.S. Food & Drug Administration (FDA) on January 30 a Biologics License Application (BLA) for motavizumab, an investigational monoclonal antibody (MAb) derived from recombinant DNA technology. The motavizumab BLA is supported by clinical trial data from more than 6,000 patients in which safety and efficacy in prevention of serious disease caused by respiratory syncytial virus (RSV) in high-risk pediatric patients were evaluated...MedImmune's Press Release-

Pfizer Japan, Manufacturing and Marketing Authorization for Champix

January 28, 2008 - Pfizer Japan Inc. announced that on January 25, the company received manufacturing and marketing authorization for Champix^® Tablet 0.5 mg/1mg (varenicline tartrate), a smoking cessation aid for smokers dependent on nicotine.

Champix is Japan’s first oral smoking cessation aid developed for smoking cessation treatment. Current ‘Nicotine Replacement Therapy’ relieves withdrawal symptoms associated with smoking cessation by replacing tobacco with nicotine. Champix brings about a smoking cessation effect as a non-nicotine partial agonist¹ that binds to α₄β₂ nicotine receptors in the brain with strong affinity... Pfizer's Press Release-

CAS Medical Systems, Placement of 50th FORE-SIGHT Cerebral Oximeter

February 6, 2008 – CAS Medical Systems, Inc. (NASDAQ: CASM), a medical device company focused on innovative, non-invasive vital signs monitoring, announced the placement of its fiftieth revenue-generating FORE-SIGHT monitor in North America. The FORE-SIGHT monitor, which non-invasively and continuously measures absolute cerebral tissue oxygen saturation, was commercially introduced mid-2007...CAS Medical Systems' Press Release-

Masimo, New National Standard for CO Screening by Pulse CO-Oximetry

February 19, 2008 - Masimo (NASDAQ: MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, announced that the National Fire Protection Association (NFPA) has included Carbon Monoxide (CO) screening by Pulse CO-Oximetry as part of a new national healthcare standard for firefighters potentially exposed to Carbon Monoxide poisoning. NFPA's consensus codes and standards serve as the worldwide authoritative source on fire prevention and public safety—virtually every building, process, service, design, and installation in society today is affected by NFPA documents... Masimo's press Release -

Sanofi Pasteur and Statens Serum Institut , development and marketing of a new vaccine against Tuberculosis

LYON, France, February 14, 2008 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that it has signed a collaborative research and license agreement with the Statens Serum Institut of Denmark (SSI) for the development and marketing of a new vaccine against tuberculosis (TB), a disease that causes the death of two million people, worldwide, each year... [PDF] Sanofi Pasteur' Press Release-

TOPIGEN's TPI ASM8 , European Phase 2 Clinical Study of TPI ASM8 in Patients With Asthma

January 29, 2008 - TOPIGEN Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specialized in developing products for respiratory disorders, announced the initiation of patient dosing in clinical protocol TPI ASM8-205, a Phase 2 safety and efficacy study in asthma with one of its lead product candidates, TPI ASM8. This study builds on prior pharmacodynamic and safety data in a three-day study of TPI ASM8 in an allergen challenge model and will be conducted in collaboration with leading clinical research centers across Europe, including the UK, Netherlands, France and Italy. TPI ASM8 is a novel, inhaled anti-inflammatory, RNA-targeting drug intended for the management of moderate to severe asthma... [PDF] TOPIGEN's Press Release-

GlaxoSmithKline and TB Alliance, Tuberculosis Drug Discovery Program

January 24, 2008 - GlaxoSmithKline (GSK) and the Global Alliance for TB Drug Development (TB Alliance) have renewed their joint research program with the goal to improve the treatment of tuberculosis (TB), which is caused by the bacillus Mycobacterium tuberculosis (M.tb). The research collaboration, initiated in 2004, currently includes a portfolio of early projects which may ultimately yield new medicines that attack M.tb, including drug-resistance strains... TB Alliance's Press Release-

Sepracor and Nycomed : exclusive development, marketing and commercialization agreement for ciclesonide in the U.S.

Jan. 28, 2008--Sepracor Inc. (Nasdaq: SEPR) and Nycomed announced an exclusive development, marketing and commercialization agreement for ciclesonide in the United States. Ciclesonide, Nycomed's proprietary corticosteroid, has a unique activation mechanism and is the active ingredient in ALVESCO HFA (hydrofluoroalkane) Inhalation Aerosol MDI (metered-dose inhaler) for the treatment of asthma and in OMNARIS AQ Nasal Spray for the treatment of allergic rhinitis. The broad ciclesonide franchise complements Sepracor's respiratory portfolio and further leverages the company's commercial infrastructure with both OMNARIS AQ and ALVESCO HFA projected to be launched in 2008... Sepracor's Press Release - Nycomed's Press Release-

EPIX Pharmaceuticals, Collaboration with Cystic Fibrosis Foundation Therapeutics

Jan. 23, 2008 - EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced that it has received a $1.25 million milestone payment from Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation. This milestone marks EPIX and CFFT's successful completion of the development of a validated model of a full-length Cystic Fibrosis Transmembrane conductance Regulator (CFTR) ion channel protein. A mutation in the CFTR gene that codes for this channel is one of the key factors that ultimately lead to the symptoms, complications and premature mortality in people with cystic fibrosis... EPIX' Press Release-