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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

FDA approves only once-daily inhaled corticosteroid for children

Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has approved ASMANEX TWISTHALER 110 mcg (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age.

4 Feb 2008

New liquid treatment for wide-neck brain aneurysm tested at Jefferson Hospital

Neurological surgeons at Jefferson Hospital for Neuroscience are among the first surgeons in the United States using an FDA-approved liquid system for treating wide-necked brain aneurysms, which could eventually replace current treatments.

4 Feb 2008

New anti-HIV medication etravirine shows great promise

The AIDS Institute, a national public policy research, advocacy, and education organization, is encouraged with the FDA's approval of the first new non-nucleoside reverse transcriptase inhibitor (NNRTI) in nearly a decade.

4 Feb 2008

New Zealand warns of risk from anti-epileptic drugs

New Zealand's Ministry of Health drug regulation arm Medsafe is alerting health care professionals about a small increased risk of suicidal thoughts and behaviours in patients taking anti-epileptic medicines.

31 Jan 2008

Wyeth launches generic version of PROTONIX

Wyeth and its business partner, Nycomed, have announced the U.S. launch of Wyeth's own generic version of PROTONIX tablets, in response to the at-risk launch of generic pantoprazole tablets in the U.S. by Teva Pharmaceuticals USA, Inc. on December 21, 2007.

31 Jan 2008

MUSC spin-off to test wound-healing peptide gel

First-String Research, Inc. (FSR), a spin-off biotechnology company from the Medical University of South Carolina (MUSC), has begun the human clinical trial process for its unique, wound-healing peptide gel.

30 Jan 2008

M. D. Anderson, AstraZeneca form alliance to advance understanding of cancer-related pain

The University of Texas M. D. Anderson Cancer Center and AstraZeneca (NYSE:AZN) today announced that they will collaborate to help advance understanding of neuropathic pain caused by cancer chemotherapy, a side effect that often limits optimal therapeutic dosing in cancer treatments.

25 Jan 2008

Pharmacists believe drive-through windows contribute to delays, errors

Consumers who pick up their prescription medications at a pharmacy drive-through window might be jeopardizing their own safety in the name of convenience.

23 Jan 2008