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Caraco Pharmaceutical Labs announces FDA approval to market generic Metaglip

Caraco Pharmaceutical Laboratories, Ltd., has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl).

15 Jan 2008

Minister predicts role for stem cell biologists in re-shaped pharmaceutical industry

Stem cell research should have a bright future and could play an important role in tomorrow's pharmaceutical industry, Spain's Minister for Health told an international conference of stem cell biologists on January 11.

15 Jan 2008

FDA approves Tysabri to treat Crohn's disease

The U.S. Food and Drug Administration has approved Tysabri (natalizumab) for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies.

14 Jan 2008

U.S. Food and Drug Administration approves new genetic breast cancer test

The U.S. Food and Drug Administration has approved a test that helps in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer. The TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients.

14 Jan 2008

Morphotek announces agreement for development of antibodies to treat prostate cancer

Morphotek, Inc., a subsidiary of Eisai Co., Ltd., has announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the development of therapeutic antibodies to a cancer-associated protein identified by NCI researchers.

10 Jan 2008

Bio-identical hormone replacement therapies targeted by FDA

The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency.

10 Jan 2008

FDA says claims about benefits of bio-identical hormone replacement therapy are false and misleading

Health officials in the United States have issued a warning regarding so-called "bio-identical" hormone therapy (BHRT).

10 Jan 2008

New meningitis vaccine a potential new weapon against the deadly disease

In a joint venture British and Canadian researchers have found that a new type of meningitis vaccine offers immunity to infants as young as six months from the deadly disease.

9 Jan 2008

NicOx extends ophthalmology agreement with Pfizer

NicOx S.A. has announced it has signed an extension of its March 2006 collaboration agreement, which grants Pfizer Inc the exclusive right to apply its proprietary nitric oxide-donating technology to drug discovery research in the field of ophthalmology.

9 Jan 2008

Analysis defines impact of Medicare Part D

The most thorough study to date of the impact of the Medicare Prescription Drug Benefit (Part D) found that this benefit led to a 13.1 percent decrease in out-of-pocket expenses for patients and a 5.9 percent increase in prescription use.

9 Jan 2008

Magen BioSciences licenses dermatology compounds from Lilly

Magen BioSciences, Inc., a privately held specialty pharmaceutical company focused on developing pharmaceuticals to treat diseases of the skin, announced today that it had acquired the rights to a series of novel pre-clinical compounds from Eli Lilly and Company.

8 Jan 2008

FDA warnings appeared to effectively increase perception of risks involved with antidepressant treatment

U.S. Food and Drug Administration warnings regarding the risk of suicidal thoughts and behaviors in children and adolescents taking antidepressants appear to have had modest and targeted effects on the intended populations, according to a report in the January issue of Archives of General Psychiatry.

8 Jan 2008

Baxter to develop recombinant Factor IX proteins to treat hemophilia B

Baxter International Inc. has announced that it has initiated pre-clinical programs to develop recombinant Factor IX proteins to treat hemophilia B.

From Baxter International Inc. 7 Jan 2008

Experts say far too much is spent on needless indigestion drugs

According to two experts in Britain the National Health Service (NHS) is needlessly spending at least 100m pounds per year on indigestion drugs.

7 Jan 2008

Takeda submits NDA for Alogliptin (SYR-322) in the U.S.

Takeda Pharmaceutical Company Limited (Takeda) has announced that Takeda Global Research & Development Center, Inc. submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes.

7 Jan 2008

Daiichi Sankyo, Lilly submit NDA for investigational antiplatelet drug, Prasugrelin U.S.

Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA).

7 Jan 2008

New flu vaccine protects against all strains including bird flu

A new flu vaccine which protects against all strains of influenza has had promising results in trials.

6 Jan 2008

Watson Pharmaceuticals launches generic Biaxin

Watson Pharmaceuticals, Inc. has announced it has launched Clarithromycin Extended-Release Tablets, USP in the 500 mg strength.

4 Jan 2008

Prescription drug ads on television minimize risk information

Prescription drug ads on television first hit the airwaves just over a decade ago, but a new University of Georgia study finds that most of them still do not present a fair balance of information, especially when it comes to the risk of side effects.

4 Jan 2008

Sanofi Pasteur enters agreement eith Crucell for next-generation biologicals against rabies

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has signed an exclusive collaboration and commercialization agreement with Crucell N.V. for Crucell's rabies monoclonal antibodies (MAbs), next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.

4 Jan 2008