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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

Diovan (valsartan) granted pediatric exclusivity by FDA

Diovan (valsartan) has been granted pediatric exclusivity by the US Food and Drug Administration (FDA) based on studies conducted in children with high blood pressure.

13 Aug 2007

Special nasal cream will bust deadly superbugs

A special cream enriched with bacteria-busting viruses has been developed by scientists in Britain and it could eradicate deadly superbugs such as MRSA from hospitals.

13 Aug 2007

Actavis receives FDA OK for generic Inderal capsules

Actavis Group has announced that it has received approval from the U.S. Food & Drug Administration to market Propranolol Hydrochloride extended-release capsules. Distribution of the product will commence immediately.

13 Aug 2007

Sanofi pasteur ships doses of Fluzone influenza vaccine for the 2007-2008 season

Sanofi pasteur, the vaccines division of the sanofi-aventis Group, has begun shipment of influenza vaccine (Fluzone, Influenza Virus Vaccine) in the United States for the 2007-2008 season.

13 Aug 2007

FDA taking no chances when it comes to drug safety

These days the U.S. Food and Drug Administration (FDA) is taking no chances when it comes to the safety of new drugs.

13 Aug 2007

Biomira and Merck KGaA sign agreements on Stimuvax

Biomira Inc. has announced the signing of amended and restated collaboration and supply agreements related to Stimuvax with Merck KGaA of Darmstadt, Germany.

12 Aug 2007

90 percent of seniors now have prescription drug coverage

More than 90 percent of Americans age 65 and older now have prescription drug coverage, compared to more than 75 percent who were covered in 2004, according to a University of Michigan analysis. And poor seniors are as likely to have coverage as the rich.

12 Aug 2007

GSK receives FDA 'not approvable letter' for Advair for COPD

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).

9 Aug 2007

Court says terminally ill have no right to experimental drugs

An appeals court in the United States has ruled that terminally ill patients do not have a constitutional right to experimental drugs not approved by regulators.

8 Aug 2007

Cannabis mouth spray eases pain of cancer patients

Canadian health authorities have given approval for a new cannabis-based painkiller for use with cancer patients.

8 Aug 2007

U.S. stocks up again on bird flu vaccine

The Department of Health and Human Services in the United States has ordered more doses of the avian flu vaccine from the international pharmaceutical giant GlaxoSmithKline (GSK).

7 Aug 2007

New drugs to combat bioterrorism

The University of Illinois at Chicago College of Pharmacy has received a grant from the U.S. Department of Defense to develop new drugs to combat agents of bioterrorism.

7 Aug 2007

FDA approves maraviroc, an antiretroviral drug for use in adult HIV patients.

The U.S. Food and Drug Administration (FDA) has approved maraviroc, an antiretroviral drug for use in adult HIV patients. Maraviroc, sold under the trade name Selzentry, is the first in a new class of drugs designed to slow the advancement of HIV and received priority review by the FDA.

7 Aug 2007

GlaxoSmithKline receives bulk H5N1 antigen order for the US national stockpile

GlaxoSmithKline has announced that HHS has placed another order to purchase bulk H5N1 antigen for the US national stockpile of pre-pandemic vaccines.

6 Aug 2007

Money for medicine

Last week, it was announced that drug addicts in England are to be given shopping vouchers for complying with treatment programmes. In this week's British Medical Journal, two experts debate whether it is acceptable for people to be paid to adhere to medication.

3 Aug 2007

FDA, DoD collaborate on regulated drugs, biologics, and medical devices

Data from the U.S. Military Health System will soon help the U.S. Food and Drug Administration make decisions affecting the safety and use of FDA-regulated products for all Americans.

3 Aug 2007