Pharmaceutical News

RSS

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

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