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Health Canada approves VIBATIV for treating complicated skin and skin structure infections

Astellas Pharma Canada, Inc. announced today that Health Canada has approved VIBATIV(TM) (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

1 Oct 2009

Addrenex submits a sNDA to the FDA for Clonicel

Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

1 Oct 2009

Diamyd Medical signs agreement with Inclinix to conduct global Phase III program

Diamyd Medical announces today that the company has signed an agreement with Inclinix Inc., North Carolina, for accelerated recruitment of children and adolescents recently diagnosed with type 1 diabetes in the US Phase III study of the diabetes vaccine Diamyd(R).

1 Oct 2009

Scientific Advisory Board to provide guidance to support the development of FST-100

Foresight Biotherapeutics announced today the formation of its scientific advisory board to provide guidance to the company for the development of it’s lead product FST-100, a novel formulation of dexamethasone that includes povidone-iodine. Foresight’s Scientific Advisory Board is comprised of leaders in the field of Ophthalmology.

1 Oct 2009

CVS Caremark to offer vouchers worth $3 million for free seasonal flu shots

With the unemployment rate currently at the highest in over two decades, CVS Caremark today announced it has begun to provide 100,000 free seasonal flu shots to the unemployed as part of its efforts to help keep Americans healthy this flu season. The initiative kicks off today at The Work Place, a member of the Massachusetts Career One-Stop Initiative in Boston.

1 Oct 2009

FDA releases first draft guidance on Risk Evaluation and Mitigation Strategies for select drugs

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

1 Oct 2009

Study aims to discover effective antibiotics to fight against hard-to-treat microbes

Scientists are reporting discovery of a much sought after crack in the armor of a common microbe that infects the stomachs of one-sixth of the world's population, causing stomach ulcers and other diseases. They identified a group of substances that block a key chemical pathway that the bacteria need for survival.

1 Oct 2009

Cutting Edge Information hopes to see ill patients have speedier access to potential cures

The FDA has approved the first set of vaccines aimed at preventing H1N1 infection after an approval process of less than four months. Cutting Edge Information is currently analyzing the lessons learned that may emerge for both the Food and Drug Administration (FDA) and life science firms after this crisis experience.

1 Oct 2009

USPTO allows BioMarin's claims covering the approved administration of sapropterin dihydrochloride with food

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the United States Patent and Trademark Office has allowed claims covering the approved administration of Kuvan® (sapropterin dihydrochloride) with food, based on the discovery that food increases the bioavailability of Kuvan. The company expects that the patent, which expires in 2024, will officially issue later this year.

1 Oct 2009

Drug companies take immediate measures to deliver millions of H1N1 vaccines

Drug companies are sprinting ahead in a race against the clock to deliver millions of doses of vaccine for the H1N1 influenza virus before cooler weather ushers in the 2009-2010 flu season. A two-part cover story in the current issue of Chemical & Engineering News, ACS' weekly newsmagazine, focuses on that topic and efforts to develop antiviral drugs for flu infections.

1 Oct 2009

FDA completes inspection of Hovione's API plant in Loures, Portugal

Hovione's API plant in Loures, Portugal has just successfully passed a pre-approval inspection by FDA

1 Oct 2009

Researchers stress the importance of ensuring quality psychiatric treatment in general practice settings

Fifty-nine percent of all prescriptions filled for psychotropic medications are written by general practitioners, according to a research report published this month in Psychiatric Services.

1 Oct 2009

Medicaid members to receive cover for administration cost of the H1N1 vaccine from WellCare

WellCare Health Plans, Inc. (NYSE: WCG) announced it will cover the full cost of administration of the H1N1 vaccine as a preventative care benefit for Medicare Advantage, Medicare private fee-for-service (PFFS) and Medicaid plan members when it becomes available to the public.

1 Oct 2009

Bristol-Myers announces availability of ERBITUX for metastatic colorectal cancer treatment

Bristol-Myers Squibb Canada is pleased to announce that the Ontario government has made ERBITUX(TM) (cetuximab) available to patients suffering from metastatic colorectal cancer. This decision makes Ontario the second province, after British Columbia, to introduce funding for this important treatment option and represents encouraging news for those patients who rely on provincial drug coverage and stopped responding to standard treatments for metastatic colon cancer.

1 Oct 2009

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

Pharmaceutical News

Health Canada approves VIBATIV for treating complicated skin and skin structure infections

Addrenex submits a sNDA to the FDA for Clonicel

Diamyd Medical signs agreement with Inclinix to conduct global Phase III program

Scientific Advisory Board to provide guidance to support the development of FST-100

CVS Caremark to offer vouchers worth $3 million for free seasonal flu shots

FDA releases first draft guidance on Risk Evaluation and Mitigation Strategies for select drugs

Study aims to discover effective antibiotics to fight against hard-to-treat microbes

Cutting Edge Information hopes to see ill patients have speedier access to potential cures

USPTO allows BioMarin's claims covering the approved administration of sapropterin dihydrochloride with food

Drug companies take immediate measures to deliver millions of H1N1 vaccines

FDA completes inspection of Hovione's API plant in Loures, Portugal

Researchers stress the importance of ensuring quality psychiatric treatment in general practice settings

Medicaid members to receive cover for administration cost of the H1N1 vaccine from WellCare

Bristol-Myers announces availability of ERBITUX for metastatic colorectal cancer treatment

Swine flu vaccine distribution plan for Pennsylvania

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

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

Update from BioCryst Pharmaceuticals regarding intravenous peramivir

CBR Pharma reports on M&A in the biopharmaceutical industry

Inspirion Delivery Technologies completes Pre-IND meeting with the FDA

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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