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Swine flu vaccine distribution plan for Pennsylvania

The Pennsylvania Department of Health today discussed the state's distribution plans for the new pandemic H1N1 vaccine.

1 Oct 2009

EMD Serono submits NDA for Cladribine Tablets in the U.S.

EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).

1 Oct 2009

Poll reveals that 43% of American adults undecided about getting the swine flu vaccine

According to a new Consumer Reports poll, 43 percent of American adults say they're on the fence about getting the swine flu vaccine and just 34 percent of those polled plan on getting the swine flu vaccine when it becomes available. Additionally, a mere 35 percent of parents say they'll definitely have their children vaccinated. The Centers for Disease Control and Prevention recommends that all children over the age of 6 months get the vaccine.

1 Oct 2009

Update from BioCryst Pharmaceuticals regarding intravenous peramivir

BioCryst Pharmaceuticals, Inc. today announced that it has delivered a written response to the request for proposal (RFP) announced on September 21, 2009 from the U.S. Department of Health & Human Services (HHS) for the supply of intravenous (i.v) peramivir for the treatment of critically ill influenza patients under Emergency Use Authorization (EUA). BioCryst management intends to provide an update once the RFP process has reached a conclusion.

1 Oct 2009

CBR Pharma reports on M&A in the biopharmaceutical industry

The history of the pharmaceutical industry is closely linked to the business practices of the combination and purchase of corporations. From the creation of the combined entity of Warner-Lambert in 1955, to the purchase of Warner-Lambert by Pfizer in 2000, to the recent acquisition of Wyeth, pharmaceutical and biotech companies have expanded their pipelines, portfolios, and sales forces through mergers and acquisitions (M&A).

30 Sep 2009

Inspirion Delivery Technologies completes Pre-IND meeting with the FDA

Inspirion Delivery Technologies, LLC ("IDT") announced today that last week the Company completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to determine the clinical and regulatory pathway to advance its abuse deterrent, extended release formulation of oxycodone.

30 Sep 2009

Emergent BioSolutions receives NIAID funding support for dmPA7909 anthrax vaccine candidate

Emergent BioSolutions Inc. announced today that it was awarded a cooperative agreement from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to further the development of one of Emergent’s advanced anthrax vaccine candidates known as dmPA7909.

30 Sep 2009

Amicus Therapeutics to initiate Phase 1 study of AT2220

Amicus Therapeutics today announced it plans to initiate a Phase 1 study of AT2220 (1-deoxynojirimycin HCl), its investigational drug in development for the treatment of Pompe Disease.

30 Sep 2009

Caraco enters into a consent decree with the FDA regarding its drug manufacturing operations

Caraco Pharmaceutical Laboratories, Ltd. announced today that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's drug manufacturing operations. The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area facilities.

30 Sep 2009

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

30 Sep 2009

Sun Pharma Global issues notice to Labopharm regarding its generic versions of Ryzolt

Labopharm Inc. today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.

30 Sep 2009

Orphan drug designation for pixantrone applied by Cell Therapeutics

Cell Therapeutics, Inc. ("CTI") announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL.

30 Sep 2009

IDRI and Academia Sinica sign Memorandum of Understanding

On behalf of The Lilly TB Drug Discovery Initiative, the Infectious Disease Research Institute (IDRI) today signed a Memorandum of Understanding (MOU) with Academia Sinica, a research institution based in Taiwan, to collaborate in target-based screening for the discovery of new tuberculosis (TB) drugs.

30 Sep 2009

Mellow Hope granted H1N1 license by SFDA

The issuer's China based operating subsidiary Mellow Hope through its exclusive business partner Zhejiang Tianyuan Bio-pharmaceutical Co., Ltd has been granted H1N1 license on September 24, 2009 by SFDA (China Authority) http://eng.sfda.gov.cn/eng. Mellow Hope is the exclusive agent of Zhejiang Tianyuan Bio-pharmaceutical Co., Ltd for International marketing and sales.

30 Sep 2009

FDA's Structured Product Labeling to be discussed

The Center for Business Intelligence (CBI) is pleased to announce the full agenda for their forum on FDA's Structured Product Labeling (SPL R4). The inaugural program will be chaired by Theresa Brunone, Assistant Director, GlaxoSmithKline. The conference will take place in Washington, DC, on December 8-9, 2009.

30 Sep 2009

Non-human primate study results of Restanza released

Advanced Life Sciences Holdings, Inc., today announced positive top-line results from a pivotal, non-human primate study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) demonstrating statistical significance at a 90% survival rate against an inhaled lethal dose of plague.

30 Sep 2009

Tβ4 therapy in EAE mice improves neurological functional recovery

REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers at the Henry Ford Health System in Detroit, Michigan, demonstrated for the first time that Tβ4 treatment of EAE (experimental autoimmune encephalomyelitis – an animal model for multiple sclerosis) significantly improves neurological functional recovery.

30 Sep 2009

Sanofi-aventis announces study results comparing efficacy of Lantus to detemir

Sanofi-aventis announced today results of a head-to-head study providing further evidence on the efficacy of once-daily, 24-hour basal insulin Lantus(R) (insulin glargine (rDNA) injection) compared to twice-daily insulin detemir. The study was presented during the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna.

30 Sep 2009

SATAI invests $1.045 million in Azaya Therapeutics

SATAI (www.satai.us) and the South Texas Regional Center of Innovation and Commercialization (www.strcic.com) today announced an investment of $1.045 million in Azaya Therapeutics, Inc. through the Texas Emerging Technology Fund (ETF) for the commercialization of Azaya’s proprietary Protein Stabilized Nanoparticle (PSN) technology platform to produce targeted, safer and more effective formulations of chemotherapy pharmaceuticals for the treatment of cancer.

30 Sep 2009

New anticoagulant therapy has fewer side-effects than warfarin

In an article reviewed by F1000 Medicine Faculty Members Robert Ruff, Brian Olshansky and Luis Ruilope, the blood-thinner dabigatran is shown to protect against stroke, blood clotting and major bleeding as effectively as warfarin, but with fewer side effects.

30 Sep 2009