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Teva's ANDA for Provigil entitled to 180-day exclusivity

Teva Pharmaceutical Industries Ltd. announces that the FDA has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil (modafinil) and therefore Teva's ANDA alone is entitled to 180-day exclusivity.

6 Apr 2012

Antibiotics may have absolutely no effect within a few decades

The increased resistance of bacteria to antibiotics is a global problem. Antibiotics are increasingly less effective. Microbiologist Dr. John Hays of Erasmus MC in Rotterdam is sounding the alarm: "The problem is so dire that within a few decades antibiotics will have absolutely no effect".

6 Apr 2012

Regeneron, Sanofi announce clinical and regulatory update for ZALTRAP

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review of the Biologics License Application (BLA) for the investigational agent ZALTRAP (aflibercept) concentrate for solution for infusion in combination with the irinotecan-fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen.

6 Apr 2012

Methylphenidate may help induce recovery from propofol anesthesia

The ability of the commonly used stimulant methylphenidate (Ritalin) to speed recovery from general anesthesia appears to apply both to the inhaled gas isoflurane, as previously reported, and to the intravenous drug propofol. Members of the same Massachusetts General Hospital (MGH) research team that reported the isoflurane study are publishing similar results for propofol in the May issue of Anesthesiology, and their paper has been issued online.

6 Apr 2012

AP: Prescription painkiller sales have 'exploded,' leading experts to fear 'addiction epidemic'

Sales of the nation's two most popular prescription painkillers have exploded in new parts of the country, an Associated Press analysis shows, worrying experts who say the push to relieve patients' suffering is spawning an addiction epidemic.

6 Apr 2012

Positive effect of tafamidis on neurological degeneration

Tafamidis meglumine was approved in November 2011 for the treatment of transthyretin amyloidosis in adults. This rare disorder is caused by a defective gene and is associated with progressive nerve damage (neurological degeneration) that tafamidis is supposed to delay.

6 Apr 2012

Purdue Pharma launches Intermezzo for middle-of-the-night insomnia

Purdue Pharma L.P. announced today that Intermezzo (zolpidem tartrate) sublingual tablet CIV is now available in 1.75 mg and 3.5 mg dosage strengths by prescription in retail pharmacies nationwide.

6 Apr 2012

Astellas' mirabegron for OAB receives FDA advisory committee approval

Astellas Pharma US, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., announced today that the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration voted that the overall risk/benefit assessment supports approval of mirabegron for the treatment of overactive bladder.

6 Apr 2012

African-Americans and Hispanics with MDD less likely to get antidepressants

African-Americans and Hispanics with major depressive disorder are less likely to get antidepressants than Caucasian patients, and Medicare and Medicaid patients are less likely to get the newest generation of antidepressants.

6 Apr 2012

Mylan seeks to overturn FDA decision on generic Provigil

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia seeking to overturn a decision by FDA, which awarded Teva sole 180-day exclusivity for the generic version of its affiliate Cephalon's Provigil.

6 Apr 2012

Doctors continue to prescribe dangerous nifedipine drug to elderly patients

Despite the fact that nifedipine increases the risk of heart attacks and death, doctors still prescribe this immediate-release blood pressure drug to elderly patients. The Cologne-based research group led by Ingrid Schubert has now published the results of their investigation in the current issue of Deutsches -rzteblatt International.

6 Apr 2012

USPTO issues patent to ChromaDex’s pterostilbene

The U.S. Patent and Trademark Office has granted patent #8,133,917 pertaining to the ingredient pterostilbene, which is licensed exclusively to ChromaDex Corp., an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, cosmetic and pharmaceutical industries, and marketer of BluScience, its new line of dietary supplements.

6 Apr 2012

Weight loss pill Qnexa wins panel vote and awaits approval

The drug was rejected in a 10-6 vote the first time it came before a Food and Drug Administration (FDA) advisory panel, in 2010, due to safety concerns. However when the medication returned for another review in February, the advisory committee gave it near-unanimous approval (20-2). Because the FDA often follows the advisory panel's advice, Qnexa is likely to get FDA approval, probably by mid-April.

5 Apr 2012

FDA alerts on fake cancer drug imports

This week, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals that 120 vials of fake cancer drug Altuzan - which contained no active ingredient - had entered the U.S from distributors in the U.K. after being purchased from wholesalers in Turkey.

5 Apr 2012

Opportunity for developers and marketers of EGFR inhibitors in Brazil and Mexico

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that patient access to premium-priced targeted cancer treatments in Brazil and Mexico is improving, creating an opportunity for developers and marketers of epidermal growth factor receptor (EGFR) inhibitors.

5 Apr 2012

Understanding how key decision makers assess prescription drugs for health plan coverage

As medical advancements and an expanding pharmaceutical industry bring new prescription drugs into the market, deciding which ones to cover is becoming an even more difficult choice for health plans to make. How those decisions are made - and what information is used in the process - was the focus of a recent study by researchers at RTI International.

5 Apr 2012

Drug dispensing robots can harbor dangerous bacteria

Drug dispensing robots designed to quickly prepare intravenous medications in a sterile environment can harbor dangerous bacteria, according to a report in Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America.

5 Apr 2012

Only few women consume aspirin to reduce risk of heart disease

Heart disease is the leading cause of death among women, and evidence-based national guidelines promote the use of daily aspirin for women at increased risk for cardiovascular disease. However, less than half of the women who could benefit from aspirin are taking it, according to an article in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc.

5 Apr 2012

Novel approach to kill acute lymphoblastic leukemia cells

Nora Heisterkamp, PhD, and Reshmi Parameswaran, PhD, of The Saban Research Institute of Children's Hospital Los Angeles, have found a novel approach to killing acute lymphoblastic leukemia (ALL) cells. Using a fusion toxin that specifically targets cancer cells, this novel therapeutic may offer a future alternative to patients who become resistant to chemotherapy.

5 Apr 2012

ARI-4175 drug may treat colorectal cancer patients with KRAS mutation

When combined with other treatments, the drug cetuximab-which works by slowing or stopping the growth of cancer cells-has been shown to extend survival in certain types of cancer, including metastatic colorectal cancers. Unfortunately, about 40 percent of colorectal cancer patients-specifically those who carry a mutated form of a gene called KRAS-do not respond to the drug. Researchers at Fox Chase Cancer Center in Philadelphia, however, have been working on a way to overcome this resistance to cetuximab by unleashing a second cetuximab driven mechanism using a novel drug called ARI-4175.

5 Apr 2012