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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

Indevus submits new drug application for NEBIDO

Indevus Pharmaceuticals, Inc. has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NEBIDO (testosterone undecanoate) intramuscular injection, a long-acting testosterone therapy intended to treat male patients with primary and secondary hypogonadism.

29 Aug 2007

FDA approves cobas TaqScreen WNV test for West Nile virus

The U.S. Food and Drug Administration has announced approval of a second test for the detection of West Nile virus (WNV) in blood and organs.

29 Aug 2007

FDA approves new Roche direct detection of West Nile Virus in donated human blood

Roche Diagnostics announced that the US Food & Drug Administration (FDA) has approved its biologics license application for the company's test for direct detection of West Nile Virus in donated human blood and plasma.

From Roche Sequencing and Life Science 29 Aug 2007

Seroquel XR tablets approved in Netherlands for the treatment of schizophrenia

AstraZeneca today announced the Netherlands regulatory authority MEB (Medicines Evaluation Board) has approved Seroquel XR (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients.

29 Aug 2007

FDA grants orphan drug designation to TREANDA

Cephalon, Inc. announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company's investigational therapy, TREANDA (bendamustine HCl), for the treatment of chronic lymphocytic leukemia (CLL).

29 Aug 2007

Avicena signs distribution agreement with RITA Corporation for dermaceutical compounds

Avicena Group, Inc., a late-stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases as well as dermaceutical products announced today that it has signed an exclusive worldwide distribution agreement with RITA Corporation, a leading supplier of specialty chemicals to the personal care industry.

29 Aug 2007

FDA approves Evithrom (human thrombin)

The U.S. Food and Drug Administration has approved Evithrom (human thrombin), a blood-clotting protein used to help control bleeding during surgery.

28 Aug 2007

Pharmacist Services Technical Advisory Coalition awarded grant from Community Pharmacy Foundation

The Pharmacist Services Technical Advisory Coalition (PSTAC), an alliance of seven national pharmacy organizations, has recently been awarded a grant from the Community Pharmacy Foundation to support an educational campaign on Current Procedural Terminology (CPT) codes used for Medication Therapy Management Services (MTMS) provided by pharmacists.

28 Aug 2007

IDM Pharma receives not approvable letter for Mifamurtide for treatment of osteosarcoma

IDM Pharma, Inc. ( NASDAQ:IDMI ) announced today that it received a not approvable letter from the U.S. Food and Drug Administration (FDA) after completing the review of the new drug application (NDA) for the investigational drug mifamurtide (L-MTP-PE), formerly known as Junovan, for the treatment of non-metastatic osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.

28 Aug 2007