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Wyeth victorious in Philadelphia diet drug case

Wyeth has announced that the jury in the cases of Janice Kydd v. Wyeth and Kathy Huber v. Wyeth in the Philadelphia Court of Common Pleas found in favor of Wyeth. The verdict came at the close of the first (damages) phase of this bifurcated (two-phase) trial.

23 Apr 2005

Suicide link with epilepsy drugs examined

The U.S. Food and Drug Administration (FDA), is asking 14 drug manufacturers to check their data for any evidence that epilepsy drugs trigger suicidal thoughts or behaviour.

22 Apr 2005

Emergency contraceptive Plan B now available over the counter in Canada

The emergency contraceptive drug Plan B will now be available over the counter in all of Canada as Health Canada yesterday ended the prescription requirement for Paladin Labs Inc.'s contraceptive.

20 Apr 2005

Canada approves use of cannabis spray for MS sufferers

In a world first Canada has taken the lead in approving the use of a cannabis spray that relieves pain in multiple sclerosis sufferers.

20 Apr 2005

Fast Track designation for Terlipressin in type 1 hepatorenal syndrome

Protein Design Labs, Inc. and privately held Orphan Therapeutics, LLC today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to the development of terlipressin for the treatment of patients with type 1 hepatorenal syndrome (HRS).

20 Apr 2005

Halozyme Therapeutics receives FDA clearance for Cumulase

Halozyme Therapeutics has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Cumulase for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States for cumulus removal in the IVF process.

20 Apr 2005

New chemical reaction that could greatly accelerate pharmaceutical production

University of Toronto researchers have a developed a new chemical reaction that could greatly accelerate pharmaceutical production, while also cutting costs and toxic by-products.

19 Apr 2005

Patients' lives at risk from substandard drugs

Global action is needed to counter the dangers of substandard life-saving drugs that are putting patients' lives and health at risk, according to heart specialists writing in the new (19 April) issue of Europe's leading cardiology journal, the European Heart Journal.

19 Apr 2005

Cost-effectiveness of drugs may vary across borders

A study published in the journal Value in Health reviews variations in estimates of cost-effectiveness of pharmaceuticals from country to country. Data showed that the results seen in one country are not necessarily applicable in another and that decision makers need to interpret data from other countries very carefully.

19 Apr 2005

Pfizer voluntarily withdraws Bextra from New Zealand market

Pharmaceutical company Pfizer is voluntarily withdrawing the Cox-2 medicine Bextra from the New Zealand market following a request from Medsafe to suspend distribution and marketing, and will recall supplies of Bextra progressively from wholesale and pharmacy shelves over the next few days.

12 Apr 2005

FDA issues public health advisory for antipsychotic drugs

The Food and Drug Administration (FDA) has issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., “off-label”) use of certain drugs called “atypical antipsychotic drugs.”

12 Apr 2005

FDA wants warnings put on antipsychotic drugs

The Food and Drug Administration (FDA) has issued a public health advisory to health care providers, patients, and caregivers to alert them to new safety information about the use of certain unapproved or off label drugs which come under the category of “atypical antipsychotic drugs.”

11 Apr 2005

Significant progress in pSivida BioSilicon drug delivery evaluation

Global nanotechnology company pSivida Limited has announced that its evaluation of selected compounds from an undisclosed top five global pharmaceutical company has progressed successfully.

11 Apr 2005

FDA approves Ambien CR for treatment of insomnia

Sanofi-aventis announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Ambien CR (zolpidem tartrate extended release) CIV. Ambien CR is the controlled-release formulation of zolpidem, the world's leading sleep aid.

11 Apr 2005

Giuliani report calls for moratorium on prescription drug importation

As the nation tightens its borders against possible future terrorist attacks, it risks undermining security and safety by opening them to non-FDA approved prescription drugs from other countries, according to a comprehensive report released today in New York City by Giuliani Partners, headed by former New York City Mayor Rudy Giuliani.

11 Apr 2005

Increased scrutiny of new multiple sclerosis-fighting drugs after Tysabri withdrawal

The removal of Tysabri from the market soon after its introduction is expected to increase scrutiny of other similar drugs in development for multiple sclerosis (MS), says ECRI, a leading, independent health services research agency.

11 Apr 2005

Bextra withdrawn from market, strong warnings on popular painkillers

The U.S. Food and Drug Administration (FDA) has issued warnings that most popular painkillers can hurt the heart, stomach and skin, and they have told pharmaceutical giant Pfizer to withdraw Bextra a top selling painkiller.

10 Apr 2005

Test of new HIV drug

A study under way at UAB aims to determine whether the first of a new class of HIV drugs is safe and effective in preventing the virus from entering healthy cells.

10 Apr 2005

Race to market cancer vaccine

In a race to market the first vaccine against the virus that causes cervical cancer and genital warts drug manufacturers Merck & Co Inc. and GlaxoSmithKline plc are in head-to-head competition.

7 Apr 2005

pSivida moves to full development programme of pancreatic cancer product

pSivida Limited has announced that it has initiated a full development programme of its proprietary BrachySil product in a second key cancer indication. Development has commenced to evaluate the efficacy and safety of this novel brachytherapy product in pancreatic cancer, with the clinical programme scheduled to commence before the end of 2005.

7 Apr 2005