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FDA seizes Heparin from Cincinnati manufacturer

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.

7 Nov 2008

FDA approves Ranexa for the treatment of chronic angina

CV Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa(R) (ranolazine extended-release tablets) for the treatment of chronic angina.

7 Nov 2008

Fenfluramine shown to have serious long-term effects

Fenfluramine, the appetite suppressant drug banned in the US in 1997 due to fears over its links to heart conditions, has been shown to have serious long-term effects.

6 Nov 2008

SALVAT submits complete response to FDA approvable letter for CETRAXAL

SALVAT announced today the submission of the response to the FDA Approvable Letter for CETRAXAL (Ciprofloxacin 0.2% Otic Solution in Single Dose Containers).

6 Nov 2008

NCPA statement on Florida study about prescription drug prices

Health Service Online has published a study called "Variation in Drug Prices at Pharmacies: Are Drug Prices Higher in Poor Areas," by Walid F. Gellad.

6 Nov 2008

Investigational drug, MK-677 shows promise for reducing age-related frailty

Researchers at the University of Virginia Health System report that a daily single oral dose of an investigational drug, MK-677, increased muscle mass in the arms and legs of healthy older adults without serious side effects, suggesting that it may prove safe and effective in reducing age-related frailty.

5 Nov 2008

Medicaid policies vary widely for biologic disease-modifying antirheumatic drugs

Patients with inflammatory diseases such as rheumatoid arthritis now have many more treatment options than in the past, including biologic disease-modifying antirheumatic drugs (DMARDs).

5 Nov 2008

New drug tricks the body into burning off fat

French scientists have found a drug they say tricks the body into burning off fat - and it even works on a high-fat diet.

5 Nov 2008

Anti-frailty pill for seniors in the pipeline

An 'anti-frailty' pill for seniors could be in the pipeline - the pill which increases muscle mass in arms and legs of older adults is the brainchild of researchers at the University of Virginia Health System.

5 Nov 2008

Mylan receives final approval for generic version of antiepileptic Keppra

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets, 250 mg, 500 mg and 750 mg. Levetiracetam Tablets are the generic version of UCB Pharma's Keppra.

4 Nov 2008

SurModics acquires drug delivery assets of PR Pharmaceuticals

SurModics, Inc. announced today that it has acquired a portfolio of intellectual property and collaborative drug delivery projects from PR Pharmaceuticals, Inc., a drug delivery company specializing in injectable, biodegradable sustained release formulations.

4 Nov 2008

Call to explore broader use of human papillomavirus vaccines

A call to explore a broader use of HPV (human papillomavirus) vaccines and the validation of a simple oral screening test for HPV-caused oral cancers are reported in two studies by a Johns Hopkins Kimmel Cancer Center investigator.

4 Nov 2008

Anti-VEGF drugs for retinal diseases could have serious side effects

Scientists at Schepens Eye Research Institute have found that reducing the levels of vascular endothelial growth factor (VEGF), which is best known as a stimulator of new blood vessel growth, in adult mice causes the death of photoreceptors and Muller glia -- cells of the retina that are essential to visual function.

3 Nov 2008

Genentech submits application to FDA for Avastin in the most aggressive form of brain cancer

Genentech has announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin (bevacizumab) as a therapy for people with previously treated glioblastoma. If accepted by the FDA, the application would be considered for an accelerated approval that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.

3 Nov 2008

FDA accepts Arana's anti-inflammatory IND

Biotechnology company Arana Therapeutics Limited today announced that lead anti-inflammatory compound, ART621 has successfully passed review of its rheumatoid arthritis Investigational New Drug (IND) application by the US Food and Drug Administration (FDA).

2 Nov 2008

Pfizer's Toviaz (fesoterodine fumarate) receives FDA approval for the treatment of overactive bladder

Pfizer Inc has announced that the U.S. Food and Drug Administration (FDA) approved Toviaz (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms.

2 Nov 2008

GlaxoSmithKline believes there is no liver safety issue with Avandia (rosiglitazone maleate)

GlaxoSmithKline today issued the following response to a petition filed by Public Citizen to the U.S. Food and Drug Administration (FDA) on Avandia (rosiglitazone maleate), a highly effective therapy for treating type 2 diabetes when used in the appropriate patient population.

31 Oct 2008

GSK to acquire Genelabs Technologies

GlaxoSmithKline and Genelabs Technologies, Inc announced today that they have entered into a definitive agreement pursuant to which GSK will acquire Genelabs for approximately $57 million (pounds Sterling 35 million) through a tender offer of $1.30 per share in cash. This strategic acquisition will strengthen GSK's effort to develop and deliver novel therapies against the hepatitis C virus (HCV).

29 Oct 2008

FDA grants tentative approval for 75th generic anti-retroviral drug

The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush's Emergency Plan for AIDS Relief (PEPFAR).

29 Oct 2008

FDA warns Bayer HealthCare on over-the-counter aspirin product

The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

28 Oct 2008