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Lexicon files investigational NDA for LX2931 in rheumatoid arthritis

Lexicon Pharmaceuticals, Inc. has announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for LX2931, an oral drug candidate for rheumatoid arthritis and other autoimmune conditions.

13 Nov 2007

FDA strengthens warnings for erythropoiesis-stimulating agents

The U.S. Food and Drug Administration has approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia.

13 Nov 2007

FDA approves new nonprescription allergy drug Zyrtec-D

The Food and Drug Administration (FDA) has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescription use in adults and children 12 years of age and older. This drug combines an antihistamine with a nasal decongestant.

13 Nov 2007

Seattle Post-Intelligencer examines reactions of people who participated in Merck's canceled HIV vaccine

The Seattle Post-Intelligencer on Friday examined the reaction of volunteers in the Seattle arm of Merck's recently halted HIV vaccine trial. According to the Post-Intelligencer, participants who were interviewed on the condition of anonymity have voiced "decidedly mixed feelings" about participating in the trial because of safety concerns (Paulson, Seattle Post-Intelligencer, 11/9).

12 Nov 2007

Potential block buster on the horizon - new vaccine to control high blood pressure

A vaccine that would help people control their blood pressure is showing promise in early trials.

7 Nov 2007

Bavarian Nordic updates on vaccine project pipeline

In a business update, Danish-based biopharmaceutical company Bavarian Nordic, reported a number of developments in its vaccine project pipeline.

6 Nov 2007

Bayer Pharmaceuticals agrees to a marketing suspension of Trasylol

The U.S. Food and Drug Administration (FDA) has announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

5 Nov 2007

Fewer U.S. residents purchase prescription drugs from Canada, in part because of Medicare drug benefit

Online drug sales in 2006 from Canadian pharmacies to U.S. consumers dropped about 50%, from $420 million Canadian dollars in 2005 to $211 million Canadian dollars last year, according to data from IMS Health, the Philadelphia Inquirer reports.

5 Nov 2007

Big question over new blood-clot buster drug Prasugrel

New research has revealed that the drug Prasugrel produced by drug company Eli Lilly increases the risk of serious bleeding when compared to the standard therapy.

5 Nov 2007

FDA requests recall of True Man Sexual Energy and Energy Max

The U.S. Food and Drug Administration yesterday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients.

5 Nov 2007

Fabre Kramer Pharmaceuticals receives FDA decision on Gepirone ER for major depressive disorder

Fabre-Kramer Pharmaceuticals Inc. (FKP) and GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the new drug application for gepirone extended- release (ER) tablets, submitted for the treatment of adults with major depressive disorder.

5 Nov 2007

HRT breast cancer case thrown out of court

A woman who claimed hormone replacement therapy (HRT) caused her breast cancer has had her case thrown out of court.

4 Nov 2007

Review of controversy surrounding the human papillomavirus (HPV) vaccine

In an article appearing in the current issue of Clinical Pharmacology & Therapeutics, experts from the University of Pennsylvania Center for Bioethics and Johns Hopkins Berman Institute of Bioethics review the controversy surrounding the human papillomavirus (HPV) vaccine debate, and its effects on ethical and public health issues.

2 Nov 2007

Merck Serono and EPFL announce neuroscience, oncology and drug delivery partnership

Merck Serono, a division of Merck KGaA, and EPFL (Ecole Polytechnique Fédérale de Lausanne), one of the two Swiss Federal Institutes of Technology, announced the signing of a research collaboration agreement in the areas of Neuroscience, Oncology and Drug Delivery. Under this agreement, three Merck Serono-endowed Chairs will be created at EPFL: in neurodegenerative diseases, such as Alzheimer's and Parkinson's; in cancer, in the framework of the Swiss Institute for Experimental Cancer Research (ISREC); and in innovative drug delivery technologies, for instance nanoparticle vaccines.

1 Nov 2007

Pharmacies, drug wholesaler file lawsuit against Abbott over price of antiretroviral Norvir

Four pharmacy chains and one pharmaceutical wholesaler on Monday filed a lawsuit against Abbott Laboratories over the price of its antiretroviral drug Norvir, the Wall Street Journal reports.

30 Oct 2007

Transplant rejection drug boosts the risk of birth defects

Authorities in the United States have issued a warning with regard to a drug used to prevent the rejection of transplanted organs.

30 Oct 2007

Tasigna gets the green light in the U.S. to treat Chronic Myeloid Leukemia

The Food and Drug Administration (FDA) in the U.S. has given approval for a new drug to treat chronic myeloid leukemia (CML).

30 Oct 2007

FDA issues communication on ongoing safety review of Aprotinin injection

Last week, FDA was notified that a Canadian research group stopped a study on Trasylol because the drug appeared to increase the risk for death compared to the other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding.

28 Oct 2007