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The U.S. Food and Drug Administration (FDA) has issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved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

Bioniche receives funding to scale-up E. coli O157:H7 vaccine production

Bioniche Life Sciences Inc. has announced that it has secured a $5 million commercial loan from the Business Development Bank of Canada (BDC) in support of the scale-up of vaccine production at its Belleville, Ontario facility.

8 Feb 2008

FDA to stop the marketing of unapproved injectable colchicine

The U.S. Food and Drug Administration has announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout.

7 Feb 2008

U.S. FDA approval of generic Fosamax

The U.S. Food and Drug Administration today approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of a person's bones.

6 Feb 2008

New European cosmetic regulation to strengthen product safety and to cut red tape

The European Commission has proposed to simplify the European law on cosmetics and: 27 transposing national pieces of legislation representing over 3500 pages of legal text will be replaced by one single regulation.

5 Feb 2008

Study of successful drug targets could hasten development of new medications

Guidance from an innovative computational approach could speed up the process and cut down the cost of new drug development, researchers from the University of Chicago Medical Center and Columbia University suggest in a study to be published in the February 2008 issue of Genome Research, available early online.

5 Feb 2008

New FDA advisory on Chantix (varenicline)

The U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.

5 Feb 2008

Antiepileptic drug warning from FDA

The U.S. Food and Drug Administration today issued new information to health care professionals to alert them about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions.

5 Feb 2008

European regulatory agencies should employ full-time statisticians

European regulatory agencies should employ full time statisticians to enable competent licensing and labelling decisions to be made, argue leading statisticians in an open letter to this week's BMJ.

5 Feb 2008

USA Today examines possible reasons for five-year low of FDA drug approval rate

USA Today on Monday examined how some pharmaceutical industry analysts cite "more cautious regulators and less innovation by drug makers" as reasons for the low rate of new drug approvals in 2007 (Schmit, USA Today, 2/4).

4 Feb 2008