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FDA fast tracks HIV protease inhibitor from Vertex and GSK

Vertex Pharmaceuticals has announced that its collaborator, GlaxoSmithKline (GSK), has received fast track designation for the HIV protease inhibitor (PI) 640385 (VX-385) from the United States Food and Drug Administration.

19 Jul 2005

FDA examines deaths of patients using pain patches

The U.S. Food and Drug Administration (FDA) is investigating reports of the deaths of patients who were using pain patches that contain the narcotic fentanyl.

18 Jul 2005

Way now clear for FDA approval of Plan B "morning-after" pill

Now that senators Patty Murray of Washington and Hillary Clinton of New York, have dropped their objections to acting FDA Commissioner Lester Crawford becoming the permanent commissioner, approval for the sale of the Plan B "morning-after" contraceptive without a prescription should be granted with the minimum of delay.

18 Jul 2005

Bioniche launches injection for varicose veins in the U.S

Bioniche Life Sciences has announced that its Pharma Division has launched Sotradecol(R) Injection (Sodium Tetradecyl Sulfate Injection) in the United States.

15 Jul 2005

Ranbaxy receives tentative FDA approval to manufacture and market Zidovudine tablets

India's Ranbaxy Laboratories has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Zidovudine Tablets USP, 300 mg.

15 Jul 2005

FDA panel says asthma drugs should stay on market but must carry warnings

The U.S. Food and Drug Administration (FDA) advisory panel has declared that three asthma drugs are safe enough to stay on the market, after concerns that in rare cases they raise the risk of severe asthma.

14 Jul 2005

ID Biomedical's flu vaccine granted fast track status

ID Biomedical Corporation announced today it has been advised by the United States Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) that the Company's Influenza Virus Vaccine (Fluviral) has been granted a Fast Track designation.

13 Jul 2005

Australian product promotes healing in venous stasis ulcers

Novogen has announced the results of a Phase II clinical trial of its investigational wound healing compound, Glucoprime, in venous stasis ulcers.

13 Jul 2005

Approval sought for Femara in early post-surgery use

Approval is being sought in the U.S. and Europe, by Swiss drug makerNovartis, for its breast-cancer drug Femara to be used immediately after surgery to help older women fight tumours.

12 Jul 2005

Vioxx safe enough for Canadian market says health panel

A canadian health advisory panel says that Merck's arthritis drug Vioxx should be allowed to go on sale again in the country, 10 months after the company withdrew the blockbuster painkiller over reports that it increased the risk of heart disease.

11 Jul 2005

New treatment for rosacea

Galderma Laboratories has announced FDA approval of a new product for the topical treatment of the inflammatory lesions of rosacea. MetroGel (metronidazole) Topical Gel, 1% will be available by prescription July 29, 2005. The new medication incorporates a higher concentration of metronidazole in a new, technologically advanced vehicle.

6 Jul 2005

Product claiming to protect against anthrax lacks credentials or approval

The U.S. Food and Drug Administration says Bio-Germ, a lotion being promoted by a Texas businessman lacks federal approval and could face scrutiny for claims made on its Web site.

5 Jul 2005

NitroMed have launched BiDil for the treatment of heart failure in black patients

NitroMed, Inc. announced today that BiDil® (isosorbide dinitrate/hydralazine hydrochloride) is being launched for the treatment of heart failure in black patients as an adjunct to current standard therapies.

4 Jul 2005

RxKinetix receives grant to develop thermostable vaccines with improved stability at non-refrigerated temperatures

RxKinetix Inc., a specialty pharmaceutical company has received a grant offer from the prestigious Grand Challenges in Global Health initiative. The grant will be used to develop thermostable vaccines with improved stability at non-refrigerated temperatures for use in the world's poorest countries.

30 Jun 2005

Medicaid beneficiaries living with HIV/AIDS in Mississippi are about to be denied access to medications

A law that takes effect tomorrow, July 1, limits Mississippi Medicaid beneficiaries to two brand-name drugs. But controlling HIV infection requires three drugs, and all of them are brand name.

30 Jun 2005

New drug candidate against HIV-infection

As a part of a research collaboration, scientists at the Sahlgrenska Academy at Gotenborg University, Sweden, have developed a new drug candidate against HIV-infection. The new substance, named alphaHGA, will be tested on patients this year.

30 Jun 2005

Old skin fungus drug has been found to be a possible cancer treatment

A drug that has been used for 40 years for the treatment of skin fungus has been found to be a possible cancer treatment, according to an international team of scientists. Leslie Wilson, professor of biochemistry and pharmacology at the University of California, Santa Barbara, said that the antifungal drug, griseofulvin, has been shown to inhibit the growth of cancer cells in his laboratory.

30 Jun 2005

Takeda Pharmaceuticals submits NDA for a new oral diabetes medication

Takeda Pharmaceuticals North America today announced that the company has submitted a New Drug Application (NDA) for a new oral medication that combines pioglitazone HCl and glimepiride, a sulfonylurea, to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes.

30 Jun 2005

European women soon to have access to new breast cancer drug

European women suffering from breast cancer will soon have access to the breast cancer drug Arimidex after British authorities granted approval for the drug to be used in a wider range of European women with breast cancer.

29 Jun 2005

Keep taking Viagra, it won't make you blind!

In a review of its popular impotence treatment Viagra, Pfizer announced on Monday that it had found no evidence of increased risk of blindness among patients taking the erectile dysfunction drug.

28 Jun 2005