Researchers at the University of Liverpool and the Royal College of Surgeons in Ireland have discovered a gene that has the potential to indicate if epilepsy patients starting drug treatment are likely to experience side-effects resulting in blistering of the skin.
It looks as if user fees really are in the offing for generic drugs. After generics makers said last week that they’re supporting the idea as a way to speed approvals of their products, FDA Commissioner Margaret Hamburg backed it, too. Revamping the current approvals process is “critical,” she said, because agency funding won’t provide the resources to clear the backlog of apps.
Continue reading ‘Generic Fees Gain Traction with FDA Backing’
Two U.S. senators have revived the reimportation debate with a new bill co-sponsored by a bipartisan group of their fellows. Sen. Debbie Stabenow (D-Michigan) is teaming up with Sen. Olympia Snowe (R-Maine) on the proposal, which would allow U.S. pharmacies and drug wholesalers to source products from other countries with “tough safety standards.”
Continue reading ‘Senators Resurrect Reimportation with New Bill’
Zymes, a New Jersey-based biopharmaceutical company, has received a two-year $476,000 grant from the Michael J Fox Foundation (MJFF), under the Therapeutics Development Initiative Fall 2010 Program, to evaluate the effectiveness of WS-CoQ10 in stopping the progressive loss of dopamine nerve cells in animal models of Parkinson’s disease (PD).
Continue reading ‘Zymes Receives Michael Fox Foundation Grant for PD Therapy Research’
MedTrust Online and Avantra Biosciences have entered into a partnership to involve clinicians in the earliest stages of molecular diagnostic assay development for Avantra Biosciences’ revolutionary QPDx multiplex immunoassay system.
Continue reading ‘MedTrust, Avantra Partner to Develop Biomarker Assays for Cancer’
Want proof that achieving FDA approval is more difficult than in the past? A study released by the BIO and BioMedTracker that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previously the rate of approval were one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development. And large molecule drugs are twice as likely to be approved than than small molecule drugs.
A startling scientific breakthrough on Type 1 diabetes could help pave the way to a cure or perhaps significantly reduce the need for insulin therapy. A researcher at UT Southwestern, Dr. Roger Unger, reports in the February issue of Diabetes that by shutting down glucagon, a hormone that causes blood sugar to spike in patients with Type 1 diabetes, he was able to restore glucose tolerance to a normal level in mice. Even large doses of glucose failed to derail the therapeutic effect of the glucagon approach.
Continue reading ‘Diabetes Researcher May be ‘Close to a Cure’’
Every so often, someone sets up a dartboard of likely targets for Big Pharma buyouts. This time, the target-setter is Barron’s, and the focus is on companies with market values of $10 billion or less. Most of them have at least one marketed product: “It’s less dangerous playing smaller outfits with approved drugs than those with treatments still awaiting an okay from an increasingly demanding FDA,” the magazine points out.
Continue reading ‘Which Specialty Drugmakers Should Big Pharma Buy?’
India’s No.2 drugmaker Dr Reddy’s Laboratories Ltd said a U.S. district court has cleared the sale of its generic version of Sanofi-Aventis’ allergy medicine Allegra D24, sending its shares up nearly 4 percent. The U.S. District Court of New Jersey lifted an injunction passed last June against the Indian drugmaker from selling a copycat version of the drug, Dr Reddy’s said in a statement.
NPS Pharmaceuticals says that it’s on track to file for regulatory approval of Gattex after a late-stage study involving 86 patients demonstrated promising results for reducing the need for IV feeding among a majority of patients with short bowel syndrome. NPS now plans to file in the second half of the year and the news quickly spurred a 30 percent hike in its stock price in pre-market trading.
Continue reading ‘NPS Soars on Positive Ph3 Data for Orphan SBS Drug’
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