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FDA committees recommend continued U.S. marketing for Trasylol

The Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery.

13 Sep 2007

Researchers question safety of Avandia and it's longterm use

Researchers in the U.S. say the long-term use of a medication used in patients with type 2 Diabetes and people with glucose intolerance, increases the risk for heart failure and heart attacks.

12 Sep 2007

Prescription labels focus on logos not instructions

The labels on most prescription drug containers highlight the pharmacy's name or logo rather than instructions on how to take the medication, reports a new study in the September 10 issue of the Archives of Internal Medicine.

12 Sep 2007

Novel angiogenic drugs could revolutionize treatment of peripheral arterial disease

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the market entry of novel angiogenic agents, including a future blockbuster drug from Genzyme, could revolutionize symptomatic treatment of peripheral arterial disease (PAD).

12 Sep 2007

Sanofi-aventis announces settlement of average wholesale price suits with DoJ relating to Anzemet

Sanofi-aventis announced today a civil settlement with the U.S. Department of Justice to resolve "Average Wholesale Price" (AWP) lawsuits under the federal False Claims Act relating to Anzemet(R) involving one of its predecessor companies, Aventis Pharmaceuticals Inc. (API).

11 Sep 2007

Validus Pharmaceuticals acquires bipolar drug Equetro from Shire

Validus Pharmaceuticals, Inc. has announced that it has acquired the unique Bipolar Disorder treatment, Equetro(R) (carbamazepine) extended release capsules, from Shire plc.

11 Sep 2007

Mylan receives tentative FDA approval for Topiramate capsules

Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules, 15 mg and 25 mg.

11 Sep 2007

GP prescribing of antibiotics in question

GPs prescribing antibiotics often rely on their personal preferences and experience, rather than clinical evidence, says new research launched at the British Pharmaceutical Conference (BPC) in Manchester.

11 Sep 2007

$52.5 million settlement against Sepracor approved

Judge Morris E. Lasker of the U.S. District Court for the District of Massachusetts has granted final approval of a $52.5 million settlement in two separate but related securities class actions against Sepracor Inc., a Massachusetts-based pharmaceutical company.

11 Sep 2007

Generic Coreg (carvedilol) approved in U.S.

The U.S. Food and Drug Administration has approved the first generic versions of Coreg (carvedilol). Coreg is a widely used medication that is FDA-approved to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.

10 Sep 2007

FDA warns Melanocorp for illegal sale of Melanotan II

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp's Web site.

5 Sep 2007

U.S. may learn from Quebec's prescription drug plan

A new study published in The Milbank Quarterly finds a number of similarities between Canadian drug coverage and that of the United States, despite their publicized differences.

5 Sep 2007

Revlimid receives approval in Switzerland for treatment of multiple myeloma

Celgene International Sarl has announced that it's oral cancer drug, Revlimid (lenalidomide) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

5 Sep 2007

New blood pressure drug Tekturna benefits heart failure patients too

A new blood pressure drug called Tekturna made by Novartis has been found to benefit heart failure patients also.

4 Sep 2007

FDA approves Acambis smallpox vaccine

Acambis plc (Acambis) has announced that the US Food and Drug Administration (FDA) has approved its ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine for protection against smallpox.

4 Sep 2007

Hamburg to become Europe's hub of drug discovery

Hamburg is on its way to becoming a leading hub of Europe's academic drug discovery, with the northern German city's town hall today announcing the foundation of European ScreeningPort GmbH, a company that will run a state-of-the-art drug discovery service centre.

4 Sep 2007

Abbott and AstraZeneca confirm Phase III clinical trials of Fenofibrate ABT-335 and Crestor as fixed-dose combination

Abbott and AstraZeneca confirmed they will advance the development of Abbott's next-generation fenofibrate ABT-335 and AstraZeneca's CRESTOR (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III clinical trials.

3 Sep 2007

Ranbaxy receives tentative approval for Galantamine tablets

Ranbaxy Laboratories Limited (RLL), has announced that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Galantamine Hydrobromide Tablets, 4mg (base), 8mg (base), and 12mg (base).

30 Aug 2007

FDA approves Somatuline Depot to treat acromegaly

The U.S. Food and Drug Administration has approved Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly, a rare and potentially life threatening disease in adults caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland located in the brain.

30 Aug 2007

FDA should amend the product information for irinotecan

Not everyone needs a genetic test before taking the cancer drug irinotecan, and the U.S. Food and Drug Administration should modify its prescription guidelines to say so, according to researchers at the University of North Carolina at Chapel Hill.

29 Aug 2007