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Avastin approved in Europe for advanced lung cancer

Avastin (bevacizumab), Roche's innovative anti-cancer drug, was approved today in Europe for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy.

26 Aug 2007

MedImmune licenses reverse genetics technology to Novartis

MedImmune, Inc. has announced that it has licensed its proprietary reverse genetics intellectual property to Novartis to support the development and construction of new vaccine strains to produce inactivated human seasonal, pre-pandemic and pandemic influenza vaccines.

24 Aug 2007

Risperdal approved for psychiatric conditions in children and adolescents

The U.S. Food and Drug Administration has approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17.

24 Aug 2007

UVA protection in sunscreens to be shown

The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

24 Aug 2007

Roche and WHO reinforce Tamiflu as primary H5N1 treatment

The World Health Organization (WHO) has reinforced that Tamiflu (oseltamivir) is the primary recommended antiviral of choice in managing patients infected with H5N1 in updated guidance published on the WHO website today.

24 Aug 2007

More informative labels proposed for sunscreens

The Food and Drug Administration (FDA) in the United States has proposed new regulation governing the development and testing of sunscreens; they also want warnings on the labels about the risk of skin cancer linked to sun exposure.

23 Aug 2007

Antipsychotic drug Risperdal approved for use in children

The Food and Drug Administration (FDA) in the U.S. has given approval for the antipsychotic drug Risperdal to be used to treat schizophrenia and bipolar disorder in children and teenagers.

23 Aug 2007

Warning - OTC diet supplement contains undeclared diet drug

Canadians are being warned that an over-the-counter (OTC) dietary supplement has been recalled because it contains a prescription drug used in the treatment of obesity.

21 Aug 2007

Watson Pharmaceuticals receives FDA approval for generic Duragesic

Watson Pharmaceuticals, Inc. announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for fentanyl transdermal system in the 25, 50, 75 & 100 mcg/hour strengths.

21 Aug 2007

Pharmion and MethylGene announce orphan drug designation for treatment of Hodgkin's lymphoma

Pharmion Corporation, along with its collaborator MethylGene Inc., today announced that the U.S. Food and Drug Administration (FDA) has designated the Companies' histone deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan Drug for the treatment of Hodgkin's lymphoma in the United States.

21 Aug 2007

Americans popping more pills

Americans are it seems popping more pills than ever, as according to an analysis of federal data, sales of leading painkiller medications soared by 90 percent in the eight years between 1997 and 2005.

21 Aug 2007

Once a year treatment for osteoporosis now available in the U.S.

A once-a-year treatment for the bone-thinning disease osteoporosis has been given approval by the Food and Drug Administration (FDA) in the United States.

20 Aug 2007

FDA approves updated labeling for Warfarin (Coumadin)

The U.S. Food and Drug Administration has announced the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug.

17 Aug 2007

Baxter awarded major contract for flu vaccine in the event of a pandemic

Baxter International Inc. has announced that Baxter's European subsidiary in the United Kingdom has entered into an advanced supply agreement with the Department of Health that contains an option to purchase pandemic influenza vaccine in the event the World Health Organization (WHO) declares a pandemic.

From Baxter International Inc. 17 Aug 2007

Strengthened warnings on some type 2 diabetes drugs

The U.S. Food and Drug Administration has announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood.

16 Aug 2007

Rotarix accepted for review by FDA

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis.

16 Aug 2007

FDA tells drug giant to come clean about Alzheimer's drug

The Food and Drug Administration (FDA) in the U.S. has warned a major drug company about misleading the medical profession over a drug for dementia.

15 Aug 2007

Roche files investigational new drug application for second Genmab antibody

Genmab A/S has announced that its partner Roche has filed an Investigational New Drug application (IND) with the US Food and Drug Administration for a Genmab antibody developed under the companies' collaboration.

13 Aug 2007

Mylan receives FDA approval for Verapamil Hydrochloride capsules

Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Verapamil Hydrochloride (HCl) Extended-release (ER) Capsules (PM), 100 mg, 200 mg and 300 mg.

13 Aug 2007

LifeCycle Pharma and Sciele Pharma announce FDA approval of new formulation of Fenofibrate

LifeCycle Pharma and Sciele Pharma announce FDA approval of fenofibrate in 120 mg. and 40 mg. dosage strengths. Sciele Pharma expects U.S. market launch by the end of 2007.

13 Aug 2007