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FDA approves Sprycel for treatment of adults with Ph+ CP-CML

The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

29 Oct 2010

Pfizer announces approval of Lyrica capsules for peripheral neuropathic pain

Pfizer Inc announced that the Japanese Ministry of Health, Labour and Welfare approved Lyrica (pregabalin) capsules for the treatment of peripheral neuropathic pain. This follows the recent approval in Japan of Lyrica for the treatment of postherpetic neuralgia on April 16, 2010. Lyrica is the first medication approved for peripheral neuropathic pain in Japan where it is co-promoted with Eisai Co., Ltd.

29 Oct 2010

Latuda tablets receive FDA approval for treatment of adults with schizophrenia

The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

29 Oct 2010

Tenofovir gel to prevent HIV transmission nearing approval

Anti HIV drug Tenofovir in its gel form is to be fast-tracked for approval by the US FDA. The announcement was made by Conrad, a nonprofit scientific organization based in Arlington, Virginia that works with reproductive health.

28 Oct 2010

Pro-Pharmaceuticals ships first commercial order of DAVANAT to PROCAPS in Colombia

Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has shipped its first commercial order of DAVANAT® to PROCAPS S.A., a large, international pharmaceutical company based in Barranquilla, Colombia. The $200,000 shipment of DAVANAT® will be used by PROCAPS to qualify its vial filling process.

28 Oct 2010

CCS presents new 2010 Atrial Fibrillation Guidelines

The Canadian Cardiovascular Society (CCS) presented its new 2010 Atrial Fibrillation Guidelines, the first update in six years, at the Canadian Cardiovascular Congress (CCC) in Montreal.

28 Oct 2010

Federal Government seizes prescription and OTC drug products from Tri-Med Labs

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized articles of prescription and over-the-counter (OTC) drug products from Tri-Med Laboratories Inc. in Somerset, N.J. earlier this month. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.

28 Oct 2010

Essential Pharmaceuticals to commence sales of cell media products acquired from Lifeblood Medical

Essential Pharmaceuticals, LLC, a private company dedicated to providing specialty reagents and solutions to the life sciences market, announced today that the Company will commence sales and distribution of three distinct animal-component-free products: serum replacement, cryopreservation and clinical pathology media, formerly sold under the LiforCell® name.

28 Oct 2010

B. Braun initiates voluntary recall of heparin injection products

B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant.

From B. Braun Melsungen AG 28 Oct 2010

Health Canada approves PRADAX anticoagulant for stroke prevention in AF patients

Boehringer Ingelheim Ltd. today announces that Health Canada has granted approval of PRADAX (dabigatran etexilate), an oral anticoagulant for the prevention of stroke and systemic embolism in adults with atrial fibrillation in whom anticoagulation is appropriate. PRADAX is the first innovative drug approved in Canada in more than two decades to reduce the risk of stroke in Canadians with atrial fibrillation.

28 Oct 2010

Reuters examines development progress of microbicide gel to prevent HIV

Reuters reports that the developers of a vaginal microbicide gel containing the antiretroviral tenofovir, which has been found to reduce "HIV infections in women by 39 percent," said the FDA last week granted fast-track approval designation to the gel.

28 Oct 2010

Prolonged use of glucosamine linked to greater risk of developing diabetes

High doses or prolonged use of glucosamine causes the death of pancreatic cells and could increase the risk of developing diabetes, according to a team of researchers at Universit- Laval's Faculty of Pharmacy. Details of this discovery were recently published on the website of the Journal of Endocrinology.

28 Oct 2010

Sandoz initiates voluntary recall of Methotrexate Injection

Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots.

28 Oct 2010

Glaxo to pay $750 million settlement for defective, unsafe medicines

The New York Times: "GlaxoSmithKline, the British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant — the latest in a growing number of whistle-blower lawsuits that drug makers have settled with multimillion-dollar fines." The 20 medicines that were produced with "questionable safety" measures included "Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet an acid reflux drug."

28 Oct 2010

£600 million cancer drug fund for UK cancer patients

Good news for cancer patients in England, the government has announced that it would fulfill a pledge to set up a drugs fund. Earlier the Department of Health promised the extra funding after a report revealed the low level of spending in the UK on cancer medication compared to the rest of Europe.

27 Oct 2010

US FDA cracks down on importation of unapproved new drugs for personal use

The United States Food and Drug Administration (“FDA”) is cracking down on the importation of unapproved new drugs with regards to personal use. Import Alert #66-41, “Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.” (“IA 66-41”) was most recently published on September 23, 2010. IA 66-41 contains a Red List, a list of importers whose products are automatically detained for FDA violations, of over 400 firms on the charge of importing misbranded unapproved new drugs. Benjamin England, founder of FDAImports.com, LLC and former FDA Compliance Officer, attorney, and Food and Drug Law expert states that “This Import Alert has been expanded to include importers and products of drugs imported strictly for personal use rather than just targeting foreign shippers, which is FDA's normal M.O.”

27 Oct 2010

Shionogi receives expanded approval for pediatric use of i.v. peramivir in Japan

BioCryst Pharmaceuticals, Inc. announced that its partner, Shionogi & Co., Ltd. has received approval for an additional indication for use of intravenous (i.v.) peramivir to treat children and infants with influenza in Japan. In January 2010, Shionogi received the world's first approval for i.v. peramivir and launched it under the commercial name RAPIACTA® in Japan.

27 Oct 2010

BTG selects inVentiv Commercial to provide sales and training for CroFab, DigiFab products

inVentiv Commercial, a division of inVentiv Health and the industry leader in outsourced sales teams to the pharmaceutical industry, announced today that it has been selected by international specialty pharmaceuticals company BTG International Inc to provide a sales team, as well as training and fulfillment services, for the company's CroFab® and DigiFab® products.

27 Oct 2010

Quebec recognizes value of ABILIFY for treating schizophrenia and related psychotic disorders

Bristol-Myers Squibb Canada is pleased to announce that Quebec has recognized the value of ABILIFY (aripiprazole) for the treatment of schizophrenia and related psychotic disorders in adults and has agreed to list ABILIFY as a reimbursed full benefit on the Quebec public drug plans as of October 14, 2010.

27 Oct 2010

B.C. pharmacists are authorized to administer flu shots

As British Columbians get ready for flu season, the BC Pharmacy Association is reminding patients that they can get their seasonal vaccination from their pharmacist.

27 Oct 2010