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New painkiller was discovered in natural form in venomous snails in 1979

The natural form of Prialt – a new drug for severe pain approved this week by the U.S. Food and Drug Administration – was discovered at the University of Utah in 1979 by an incoming freshman studying toxins produced by cone snails.

30 Dec 2004

Information submitted via new drug applications could easily be made accessible to the public

A researcher at Oregon Health & Science University and the Portland Veterans Affairs Medical Center is calling upon the U.S. Food and Drug Administration (FDA) to share more information provided by pharmaceutical companies regarding their clinical drug trials.

28 Dec 2004

Lessons learned from troubles with COX-2 inhibitors

One of the nation’s leading cardiovascular medical researchers has issued a call for less aggressive direct-to-consumer advertising and better safety assurances of medications in a special article posted online by JAMA because of its relevance to the recent withdrawals and warning labels on the pain-relieving drugs known as COX-2 inhibitors.

28 Dec 2004

Update on world antimalarial drug supply

On 8 November, the World Health Organization (WHO) announced a shortfall of artemether + lumefantrine, an artemisinin-based combination therapy (ACT) used to treat malaria, for the period between November 2004 and March 2005

26 Dec 2004

Supply problem with the opiate painkiller, diamorphine

The UK Department of Health has advised the NHS that there is a supply problem with the opiate painkiller, diamorphine, and that stocks may rapidly reach a critical level in the next few weeks.

26 Dec 2004

FDA issues not approvable letter to Cellegy Pharmaceuticals

Cellegy Pharmaceuticals has announced receipt of a communication from the U.S. Food and Drug Administration in the form of a Not Approvable Letter for its product Cellegesic(TM) (nitroglycerin ointment).

26 Dec 2004

Public health advisory for the use of non-steroidal anti-inflammatory drug products

The Food and Drug Administration (FDA) has issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents.

23 Dec 2004

FDA approves Enablex for the treatment of overactive bladder

Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Enablex® (darifenacin) extended-release tablets (7.5mg and 15mg) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency.

22 Dec 2004

Pharmacogenomics, has the potential to spark a major, technology-driven restructuring of the health care and pharmaceuticals industries

Pharmacogenomics, the study of genetic variability in the way individuals respond to medicines, has the potential to spark a major, technology-driven restructuring of the health care and pharmaceuticals industries

21 Dec 2004

Arthritis drug caution advised by New Zealand experts

An expert New Zealand committee reviewing the safety of a group of arthritis drugs called COX-2 inhibitors has reinforced UK advice cautioning against their routine use where safe and effective alternatives are available.

21 Dec 2004

No increased cardiovascular risk seen in elderly patients taking Celebrex

The National Institutes of Health has reported in an Alzheimer's Disease prevention study that there was no increased cardiovascular risk seen in elderly patients taking Celebrex (400 mg daily) for up to three years.

21 Dec 2004

New advice on anti-inflammatory drugs called Cox-2 Inhibitors, including Celebrex

Patients who are taking Celebrex, Bextra and Arcoxia should make a non-urgent appointment with their GP to review their treatment. Patients who have established heart disease or who are at high risk of stroke will have their treatment changed.

21 Dec 2004

FDA issues advice on Naproxen

The FDA has released the following statement on NIH halting a clinical trial involving non-steroidal anti-inflammatory drugs in patients at risk of developing Alzheimer's Disease:

20 Dec 2004

Genzyme files for European approval of Myozyme for treatment of Pompe disease

Genzyme Corp. announced today that the European Medicines Agency (EMEA) has accepted its marketing authorization application for Myozyme(R) (alglucosidase alfa), an investigational enzyme replacement therapy for Pompe disease.

20 Dec 2004

Genetic markers implicated in fatal side effects of schizophrenia drug

Genaissance Pharmaceuticals today announced results from its CARING (Clozapine and Agranulocytosis Relationships Investigated by Genetics) study, reporting the discovery of genetic markers that the Company believes predict who is at risk of developing clozapine-induced agranulocytosis

20 Dec 2004

Advice for patients who have been taking Celebrex or Bextra

The recent announcement that Celebrex, a popular pain drug in the same family as Vioxx, has been found to pose an increased risk of heart problems is bound to leave many pain patients stunned, confused and worried.

20 Dec 2004

Potential safety risks with Celebrex

The Australian Therapeutic Goods Administration (TGA) has consulted today with the Chairs of its peak advisory committees, the Australian Adverse Drug Reactions Committee (ADRAC) and the Australian Drug Evaluation Committee (ADEC), about the latest research into the safety of the arthritis drug, Celebrex.

20 Dec 2004

Tentative approval for Topiramate Tablets

Ranbaxy Pharmaceuticals announced tentative approval from the U.S. Food and Drug Administration to manufacture and market Topiramate Tablets, 25 mg, 100 mg, and 200 mg. Total annual market sales for Topiramate were $1,184 million with sales of these three strengths of tablets totaling $1,129 million.

20 Dec 2004

Macugen approved for the treatment of neovascular (wet) age-related macular degeneration (AMD)

Eyetech Pharmaceuticals and Pfizer have announced that the U.S. Food and Drug Administration (FDA) approved Macugen (pegaptanib sodium injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD), an eye disease associated with aging that destroys central vision.

20 Dec 2004

Celebrex suspension

The National Institutes of Health (NIH) announced that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex™ Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI).

19 Dec 2004