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FDA approves Xiaflex drug for treatment of Dupuytren's contracture

The U.S. Food and Drug Administration (FDA) has approved Xiaflex, a new drug to treat Dupuytren's contracture (or disease) that was discovered and developed by Marie A. Badalamente, Ph.D., and Lawrence C. Hurst, M.D., in the Department of Orthopaedics at Stony Brook University Medical Center.

4 Feb 2010

Study: Generic nifedipine product not bioequivalent to Adalat XL

An extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics.

4 Feb 2010

National consensus reached on Joint Technical Statement for drug products

A pan-Canadian initiative was announced today that will ultimately have a major impact on patient safety by reducing preventable medication errors.

4 Feb 2010

Repligen receives USPTO Notice of Allowance for patent covering a recombinant form of Protein A

Repligen Corporation announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering a recombinant form of Protein A which is identical in structure to the commercial form of Protein A from Staphylococcus aureus which is used in the production of many of the world's approved monoclonal antibodies. The patent, which will remain in force until 2028, covers a new Repligen proprietary product which is now available in commercial quantities.

4 Feb 2010

New vaccine to prevent malaria infection shown promise to protect young children

A new vaccine to prevent the deadly malaria infection has shown promise to protect the most vulnerable patients - young children - against the disease, according to an international team of researchers led by the University of Maryland School of Medicine's Center for Vaccine Development (CVD) and the Malaria Research and Training Center at the University of Bamako in Mali, West Africa.

4 Feb 2010

New York Times examines WHO process for getting H1N1 vaccines to countries in need

The New York Times examines the WHO's role as a "clearinghouse" for getting the H1N1 (swine flu) vaccine to lower income nations. Though H1N1 has died down in North America and many wealthier nations "are trying to get rid of their [vaccine] surpluses," the virus continues to circulate in regions of North Africa, Central Asia and Eastern Europe, according to the newspaper.

3 Feb 2010

Study shows Cymbalta reduces chronic low back pain

In a new study, 60 mg of Cymbalta® (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo.

3 Feb 2010

FDA approves Labopharm's OLEPTRO antidepressant for MDD

Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.

3 Feb 2010

Drug company CEOs under pressure

Dow Jones Newswires/The Wall Street Journal on Severin Schwan, chief executive of Swiss pharmaceutical company Roche Holding AG: "'It is difficult to gauge the impact of the planned U.S. healthcare reform on the pharmaceutical industry,' Schwan told reporters at a media conference to detail 2009 earnings. 'On the one hand, more U.S. citizens will be getting access to healthcare, which is positive. At the same time, pressure on drug prices will certainly increase,' he added." The wire service adds that he also said "decisions on generic biosimilars will be key" (Greil, 2/3).

3 Feb 2010

AMPYRA for MS: Acorda Therapeutics announces wholesale pricing and patient assistance program

Acorda Therapeutics, Inc. today announced the wholesale acquisition cost (WAC) for AMPYRA™ (dalfampridine) Extended Release Tablets will be $1,056 per 30-day supply (60-count pill bottle), an annual cost of $12,850. AMPYRA was approved on January 22, 2010 by the U.S. Food and Drug Administration (FDA) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA is expected to be available in March 2010.

3 Feb 2010

Louisiana residents can now save money with free prescription drug cards

The Saints are going to the Super Bowl and we couldn't be any happier. We wanted to throw out a small lagniappe for our fellow Louisiana residents and offer the free drug card program titled the WhoDatDrugCard.com . This card is available to all residents and can save you as much as 75% off your medication purchase at over 2,000 pharmacies statewide.

3 Feb 2010

New weight-loss supplement burns calories

A new weight-loss supplement tested by the University of Oklahoma Health and Exercise Science Department has the potential to burn as many calories as a 20-minute walk, according to Joel T. Cramer, assistant professor of exercise physiology.

3 Feb 2010

Research retraction underscores the safety and efficacy of MMR vaccines

The Lancet, a premier British medical journal, today retracted a study published in 1998 that drew a link between the measles, mumps and rubella (MMR) vaccine and increased incidence of autism.

3 Feb 2010

Study linking autism and vaccines is retracted by medical journal

The Lancet has formally retracted a controversial paper published 12 years ago that purported the measles-mumps-rubella vaccine causes autism.

3 Feb 2010

Hundred millions for biotech-licence

Apeiron Biologics AG (Apeiron) today announced the signing of an agreement granting GlaxoSmithKline (GSK) exclusive rights to APN01 (recombinant human Angiotensin Converting Enzyme 2, rhACE2), an enzyme biotherapeutic currently in Phase 1 development for the treatment of the Acute Respiratory Distress Syndrome (ARDS).

3 Feb 2010

Hypertension drug market to decrease through 2013 due to generic erosion and few emerging therapies

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in addition to extensive generic erosion, the hypertension drug market will be constrained through 2018 by a pipeline containing very few emerging therapies with novel mechanisms of action. Gilead's darusentan was positioned to be the next emerging therapy with a novel mechanism of action to reach the hypertension market. However, following darusentan's failure to meet its primary endpoint in the recent DORADO-AC Phase III clinical trial, further development of the agent has been terminated.

3 Feb 2010

Tips to prevent heartburn

With the Big Game approaching, many football fans across the country are preparing for viewing parties, and the non-stop eating that comes with them. But favorite football foods like pizza, wings and nachos can trigger heartburn, which can end the evening long before the last touchdown.

3 Feb 2010

CPS supports NACI recommendations for new shingles vaccine

The Canadian Pain Society (CPS) supports the National Advisory Committee on Immunization (NACI) recommendations for the use of a vaccine to significantly reduce the risk of developing herpes zoster (shingles) and post herpetic neuralgia in adults over the age of 60 without contraindications.

3 Feb 2010

BioSpecifics Technologies' XIAFLEX receives FDA approval

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX™, a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord.

3 Feb 2010

PATH to pay FDA $480,000 to speed creation of pneumococcal vaccine for developing world

The FDA on Monday said it's entering into a collaboration with the nonprofit group PATH "to speed creation of a pneumococcal vaccine for children in developing nations," United Press International reports (2/1).

3 Feb 2010