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US advisory committee recommends approval of Rotarix

The US Advisory Committee on Vaccines and Related Biological Products issued a positive recommendation today on the use of rotavirus vaccines, potentially bringing greater protection to children in the US from this common and sometimes fatal cause of severe diarrhea.

21 Feb 2008

Wyeth wins Maryland thimerosal autism case

Wyeth has announced that The Honorable Stuart R. Berger of the Circuit Court for Baltimore City in Baltimore, Maryland, has granted Wyeth's motion for summary judgment in the case of Blackwell, et al. v. Sigma Aldrich, Inc., et al - an alleged vaccine injury case claiming that Jamarr Blackwell's exposure to thimerosal-containing vaccines caused him to become autistic.

20 Feb 2008

FDA approves XYZAL (levocetirizine dihydrochloride) for allergies and chronic idiopathic urticaria

UCB and sanofi-aventis have announced that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for XYZAL (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria.

20 Feb 2008

Barr receives approval for generic Mirapex tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

20 Feb 2008

Australian neuroscientist tests Chantix

UQ pharmacy graduate Dr Selena Bartlett is starting clinical trials of a new drug that could potentially curb addictions such as smoking, drinking, gambling even depression.

20 Feb 2008

Vaccinex antibody licensed to GlaxoSmithKline

EUSA Pharma (Oxford, UK), a Vaccinex collaboration partner, has announced that it has licensed OP-R003, a human anti-interleukin-6 antibody discovered by Vaccinex, to GlaxoSmithKline.

18 Feb 2008

NIH and EPA announce new chemical toxicity testing agreement

Testing the safety of chemicals ranging from pesticides to household cleaners will benefit from new technologies and a plan for collaboration, according to federal scientists from the National Institutes of Health (NIH) and the U.S. Environmental Protection Agency (EPA), who today announced a new toxicity testing agreement.

17 Feb 2008

FDA issues good reprint practices on unapproved uses of drugs and devices

The U.S. Food and Drug Administration (FDA) has issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

17 Feb 2008

Problems with blood thinning drug could originate in China

Following a warning from the the U.S. Food and Drug Administration (FDA) that it had received reports of 4 deaths and over 300 incidents of health problems associated with a blood thinning drug, it has now been revealed that U.S. regulators never inspected the Chinese plant that makes Baxter International's heparin.

14 Feb 2008

Warning about deaths and serious reactions linked to blood thinning drug heparin

The Food and Drug Administration (FDA) in the United States says the production of a popular blood thinning drug has been halted temporarily after more than 300 reports of health problems associated with the drug.

13 Feb 2008

Fake antimalarial drugs analysis highlights threat to global health

A unique collaboration between scientists, public health workers and police has led to the arrest by the Chinese authorities of alleged traders of fake anti-malarial drugs in southern China and the seizure of a large quantity of drugs.

13 Feb 2008

Baxter's multiple-dose vial Heparin linked to severe allergic reactions

The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

11 Feb 2008

Botox under investigation

Health authorities in the United States say they are investigating reports of serious side effects linked with treatments involving Botox.

11 Feb 2008

Ranbaxy receives tentative approval for Esomeprazole Magnesium delayed-release capsules

Ranbaxy Laboratories Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration for Esomeprazole Magnesium Delayed-Release Capsules, 20 mg (base) and 40 mg (base).

8 Feb 2008

Novel drug shows promise in limiting heart attack damage

A novel drug designed to lessen muscle damage from a heart attack has passed initial safety tests at the Duke Clinical Research Institute.

8 Feb 2008

Merck to pay over $650 million for fraudulent price reporting and kickbacks claims

Merck & Company has agreed to pay more than $650 million to resolve allegations that the pharmaceutical manufacturer failed to pay proper rebates to Medicaid and other government health care programs and paid illegal remuneration to health care providers to induce them to prescribe the company's products, the Justice Department has announced.

8 Feb 2008