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FDA approves TREANDA (bendamustine hydrochloride) for chronic lymphocytic leukemia

Cephalon, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA (bendamustine hydrochloride) for Injection for the treatment of patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow disease, on March 20, 2008.

7 Apr 2008

FDA approves Rotarix

The U.S. Food and Drug Administration has announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children.

4 Apr 2008

Proteolix's Carfilzomib granted orphan drug designation

Proteolix, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to carfilzomib, a selective blocker of proteasome activity for the treatment of multiple myeloma.

3 Apr 2008

Prednisone tablets less variable than marketed drugs

The U.S. Pharmacopeial (USP) Convention has announced results of a study comparing the dissolution variability of USP Prednisone Lot P Reference Standard tablets to two marketed drugs.

2 Apr 2008

Naglazyme approved in Japan

BioMarin Pharmaceutical Inc. has announced that AnGes MG, Inc. (AnGes), BioMarin's marketing and distribution partner in Japan, has received approval for its Marketing Application for Naglazyme(R) (galsulfase) from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with Mucopolysaccharidosis VI ( MPS VI).

1 Apr 2008

FDA deadlines may compromise drug safety by rushing approval

Many medications are approved by the U.S. Food and Drug Administration on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found.

28 Mar 2008

Free drug samples may burden patients' pockets

Following free drug sample receipt, patients who receive these samples have significantly higher out-of-pocket prescription costs than those who don't, according to the first study to look at the out-of-pocket cost associated with free-sample use, published in the March 24, 2008, issue of Medical Care.

25 Mar 2008

PharmAthene signs agreement to acquire biodefense vaccines business from Avecia

PharmAthene, Inc., a biodefense company specializing in the development and commercialization of medical countermeasures against biological and chemical threats, and Avecia Biologics Limited, a contract manufacturer of biopharmaceuticals, has announced that the companies have entered into a definitive sale and purchase agreement under which PharmAthene will acquire all of the assets and intellectual property related to Avecia's biodefense vaccines business.

24 Mar 2008

EpiCept announces opinion by European Regulatory Authority on Ceplene

EpiCept Corporation has announced that the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued, as expected following the trend vote announced last month, a negative opinion regarding the marketing authorization application (MAA) for Ceplene (histamine dihydrochloride) for the remission maintenance and prevention of relapse of patients with Acute Myeloid Leukemia (AML) in first remission.

24 Mar 2008

Taking correct medications on time easier with a pill card

Free, online instructions for creating a pill card -- an illustrated medication schedule -- using only a personal or laptop computer and printer are now available from the Agency for Healthcare Research and Quality, a part of the US. Department of Health and Human Services.

24 Mar 2008

Solcara helps AstraZeneca manage media interactions

Solcara has been helping AstraZeneca manage its interactions with the media through the use of Solcara Communications Centre.

20 Mar 2008

NicOx signs agreement for commercial manufacture of Naproxcinod drug substance

NicOx S.A. (Euronext Paris: COX) has announced it has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of naproxcinod drug substance (or active pharmaceutical ingredient, API).

20 Mar 2008

Genomas awarded $1.2 million to develop DNA-guided system for management of statin therapy

Genomas, a biomedical company advancing DNA-guided medicine and personalized healthcare, has announced the award of a Fast-Track Phase I-II Small Business Innovation Research (SBIR) Grant totaling $1.2 million.

20 Mar 2008

Asthma medicines often not prescribed as guidelines recommend

More than a decade after national guidelines were issued for asthma treatment, some patients still don't receive prescriptions for the inhalers that experts say offer the safest and most effective long-term control of the disease, a new study suggests.

20 Mar 2008

FDA sends approvable letter for Ceftobiprole as treatment of complicated skin infections

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), has announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

19 Mar 2008

Reasonable Rx: Solving the drug price crisis

The mounting U.S. drug price crisis can be contained and eventually reversed by separating drug discovery from drug marketing and by establishing a non-profit company to oversee funding for new medicines, according to two MIT experts on the pharmaceutical industry.

18 Mar 2008

A new inhaled TB vaccine

A new tuberculosis vaccine successfully tested at the University of North Carolina at Chapel Hill is easier to administer and store and just as effective as one commonly used worldwide.

17 Mar 2008

Investigational drug Debio-025 tested for preventing muscle fiber death in muscular dystrophy

An investigational antiviral drug currently undergoing human trials in Europe for treating Hepatitis C infections may have potential to reduce muscle cell damage in Duchenne and other forms of muscular dystrophy (MD).

17 Mar 2008

FDA steps towards Chinese presence

In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

17 Mar 2008

Watson Pharmaceuticals files application for generic LYBREL

Watson Pharmaceuticals, Inc. has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth.

14 Mar 2008