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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

New guideline for using ESAs drugs in cancer patients

An updated joint guideline by the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO) advises physicians about the appropriate use of erythropoiesis-stimulating agents (ESAs), a class of drugs that stimulate the bone marrow to produce more red blood cells, to treat cancer patients with chemotherapy-induced anemia.

27 Oct 2010

Bivalent oral polio vaccine produces better immune response than more commonly used trivalent vaccine, study says

The bivalent oral polio vaccine (bOPV) was found to induce a significantly higher immune response than the existing trivalent oral polio vaccine (tOPV), according to a study published on Tuesday in the journal Lancet, Reuters reports.

27 Oct 2010

Study finds association between KRAS p.G13D mutations and cetuximab treatment in colorectal cancer

Even though the cancer-treatment agent cetuximab is not considered effective treatment for KRAS (a gene)-mutated metastatic colorectal tumors, new research indicates that patients with colorectal cancer not responding to chemotherapy and a certain variation of this gene who were treated with cetuximab had longer overall and progression-free survival than patients with other KRAS-mutations, according to a study in the October 27 issue of JAMA.

27 Oct 2010

Study finds anti-obesity drug reduces brain’s response to appetizing foods

Scientists have revealed that an anti-obesity drug changes the way the brain responds to appetising, high-calorie foods in obese individuals. This insight may aid the development of new anti-obesity drugs which reduce the activity in the regions of the brain stimulated by the sight of tasty foods.

27 Oct 2010

Jamieson releases flu-fighting formula with echinacea

Jamieson Laboratories, Canada's largest manufacturer of advanced natural-health products, announced the release of FluShield™, a clinically proven flu-fighting formula that is made with a patented, next-generation echinacea extract known as LPx3.

27 Oct 2010

CYP2C19 gene variant can increase risk of cardiovascular events in patients treated with clopidogrel

An analysis of data from previously published studies indicates that use of the antiplatelet drug clopidogrel for patients who have common genetic variants of a certain gene and are undergoing a procedure such as coronary stent placement have an associated increased risk for major adverse cardiovascular events, particularly development of blood clots in stents, according to a study in the October 27 issue of JAMA.

27 Oct 2010

Glaxo to pay $750 million in defective drug settlement

GlaxoSmithKline Plc, one of the world’s largest pharmaceutical companies, has agreed to pay $750 million to settle a U.S. government false-claims lawsuit over the sale of defective drugs. The lawsuit first filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the London-based company came to a settlement finally. Eckard, 51, said, “This is not something I wanted to do, but because of patient safety it was necessary.” Being the one to bring this to notice she would receive $96 million from the settlement money. She had warned the company earlier but was fired because of her efforts.

26 Oct 2010

Strativa enters amended agreement with Sobi for Nascobal Vitamin B12 Nasal Spray

Strativa Pharmaceuticals today announced that it has entered into an amended and restated license and supply agreement with Swedish Orphan Biovitrum (Sobi) covering the European development and commercialization rights of Strativa's Nascobal (cyanocobalamin) Vitamin B12 Nasal Spray. Strativa acquired the worldwide rights to Nascobal from QOL Medical, LLC in March 2009, which included a pre-existing agreement with Sobi.

26 Oct 2010

Shire receives Paragraph IV Notice Letter from Watson for INTUNIV tablet

Shire plc , the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 4 mg guanfacine hydrochloride extended release tablet, INTUNIV.

26 Oct 2010

India's Trade Minister says EU will take steps to prevent seizure of generic medicines

"India believes a row with the European Union over seizures of generic drugs will be settled without litigation, Trade Minister Anand Sharma said on Wednesday," Reuters reports (Lynn, 10/20).

26 Oct 2010

Pharmaceutical News

Reuters examines development progress of microbicide gel to prevent HIV

Prolonged use of glucosamine linked to greater risk of developing diabetes

Sandoz initiates voluntary recall of Methotrexate Injection

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

£600 million cancer drug fund for UK cancer patients

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

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

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

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

B.C. pharmacists are authorized to administer flu shots

New guideline for using ESAs drugs in cancer patients

Bivalent oral polio vaccine produces better immune response than more commonly used trivalent vaccine, study says

Study finds association between KRAS p.G13D mutations and cetuximab treatment in colorectal cancer

Study finds anti-obesity drug reduces brain’s response to appetizing foods

Jamieson releases flu-fighting formula with echinacea

CYP2C19 gene variant can increase risk of cardiovascular events in patients treated with clopidogrel

Glaxo to pay $750 million in defective drug settlement

Strativa enters amended agreement with Sobi for Nascobal Vitamin B12 Nasal Spray

Shire receives Paragraph IV Notice Letter from Watson for INTUNIV tablet

India's Trade Minister says EU will take steps to prevent seizure of generic medicines

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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