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FDA Avandia recommendation welcomed by Endocrinologists

The American Association of Clinical Endocrinologists (AACE), along with the rest of the medical community, has watched with concern the debate regarding usage of GlaxoSmithKline's rosiglitazone (Avandia) in diabetes and the question of whether it increases cardiovascular risk.

1 Aug 2007

QIAGEN acquires Digene

QIAGEN completed the acquisition through a tender offer and subsequent merger of Digene with and into a wholly owned subsidiary of QIAGEN. At the completion of the merger, Digene will become a wholly owned subsidiary of QIAGEN's affiliate QIAGEN North American Holdings, Inc.

From QIAGEN Manchester Limited 1 Aug 2007

Coated aspirin doesn't guarantee problem-free use

Some people take aspirin without ever having a problem with their stomach. Others develop low-grade stomach pain or get an ulcer.

31 Jul 2007

Biota increases damages claim against GlaxoSmithKline

Australian company Biota has filed its updated Particulars of Loss and Damage in its suit against GlaxoSmithKline (GSK) for failing to support the influenza drug, Relenza, discovered by Biota and licensed to GSK in 1990.

31 Jul 2007

Majority of FDA panel votes in favor of Avandia

GlaxoSmithKline has welcomed the nearly unanimous recommendation of an U.S. Food and Drug Administration's (FDA) advisory committee to support Avandia's (rosiglitazone maleate) continued availability to patients in the U.S.

30 Jul 2007

Takeda responds to FDA recommendation on Actos

Following a joint meeting today of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, Takeda Global Research & Development (TGRD) underscores its position that ACTOS(R) (pioglitazone HCl) offers a proven safety profile regarding the risk of cardiovascular disease.

30 Jul 2007

Avandia too risky says expert

One of the members of the advisory panel set up to discuss the future of the diabetes pill Avandia says it should be removed from the market because it is too risky and offers no advantage over other alternatives.

30 Jul 2007

Polypill cure-for-all could become a killer

Doctors in Britain are warning that offering all men over 50 and all women over 60 a pill to protect them against heart disease and stroke, will only serve to encourage an unhealthy lifestyle.

30 Jul 2007

Europe approves MIRCERA to treat anaemia

Roche has announced that the European Commission has approved its innovative drug MIRCERA to treat anaemia associated with chronic kidney disease (CKD).

27 Jul 2007

Merck appoints David Kelley, M.D., to key role in growing Diabetes and Obesity franchise

Merck & Co., Inc. has announced that David E. Kelley, M.D., has been named vice president, franchise integrator for Diabetes & Obesity. Dr. Kelley joins Merck after 20 years on staff at the University of Pittsburgh, where he most recently served as professor of medicine and director of the Obesity & Nutrition Research Center.

24 Jul 2007

FDA panel will help decide fate of drug Evista for preventing breast cancer

Before the osteoporosis drug Evista is approved for breast cancer in the U.S. the Food and Drug Administration (FDA) will take the advice of an advisory panel.

23 Jul 2007

Cannabis drug for MS - don't hold your breath!!

Medicine regulators have been accused of dragging their feet over a cannabis drug for people with multiple sclerosis.

23 Jul 2007

Wyeth wins case of Lisa Dean v. Wyeth

Wyeth has announced that the jury in the case of Lisa Dean v. Wyeth in U.S. District Court found in favor of Wyeth.

23 Jul 2007

IDM Pharma plans to amend NDA for Mifamurtide (L-MTP-PE) for the treatment of osteosarcoma

IDM Pharma, Inc. has announced that it has recently met with the U.S. Food and Drug Administration (FDA) and informed the FDA that the Company intends to take immediate action to supplement the data in its current New Drug Application (NDA) for mifamurtide (L-MTP-PE), formerly known as Junovan, which is being reviewed for the treatment of children and adolescents with non-metastatic osteosarcoma.

23 Jul 2007

European watchdog warns about dangers of Acomplia

The European Medicines Agency has warned consumers that the weight loss drug Acomplia heightens the risk of suicide among those taking anti-depressants.

21 Jul 2007

Schering-Plough announces licensing of Acadesine

Schering-Plough Corporation has announced the worldwide licensing of acadesine, an investigational, potentially first-in-class adenosine regulating agent (ARA), from PeriCor Therapeutics, Inc., a privately held, specialty biopharmaceutical company.

20 Jul 2007

Tibotec Pharmaceuticals submits NDA for investigational HIV treatment

Tibotec Pharmaceuticals Ltd. has announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for TMC125 (etravirine), an investigational non- nucleoside reverse transcriptase inhibitor (NNRTI), being studied for use with other antiretroviral (ARV) agents as a treatment for people infected with HIV- 1.

19 Jul 2007

GSK's Cervarix receives positive opinion in Europe

GlaxoSmithKline has announced that its cervical cancer candidate vaccine received a positive opinion from the European Committee for Human Medicinal Products (CHMP) for the prevention of precancerous lesions (high grade cervical intraepithelial neoplasia - CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus types 16 and 18.

19 Jul 2007

Lupin receives approval for Amlodipine tablets

Lupin Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base).

18 Jul 2007

FDA approves Extina for seborrheic dermatitis

Stiefel Laboratories, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Extina (ketoconazole) Foam, 2% for the treatment of seborrheic dermatitis.

18 Jul 2007