| Amicus Therapeutics, Inc. Q1 2010 Earnings Call Transcript Amicus Therapeutics, Inc. (FOLD)Q1 2010 Earnings CallMay 06, 2010 05:00 am ETComplete Story » seekingalpha.com |
Researchers Try to Create Human Skin A look at how scientists are trying to grow cells into natural skin. The result could someday replace skin grafting as a treatment for burn victims and those with chronic skin wounds. online.wsj.com |
Transdel Pharma Stands to Gain From Pain Medication M.E. Garza submits: The real asset for Transdel Pharmaceuticals Inc. (TDLP.OB) is their proprietary transdermal cream drug delivery platform. Pharmaceutical companies have taken notice of the technology and the company may be on the verge of big news. Utilizing this cream-based technology (called Transdel), they’ve developed their lead product called Ketotransdel, a potentially first in class, topical anti-inflammatory cream for the treatment of acute pain. Company officials feel this technology has other pharmaceutical and cosmiceutical product applications that can be developed in the future. Ketotransdel, the Company's lead late stage pain product, utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug (“NSAID”), through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. This Ketotransdel product has actually been taken through a Phase 3 trial, so it’s a late stage product. Complete Story » seekingalpha.com |
Arena Pharma’s Diet Pill and Tumors: A Big Rat? Pharmalot submits: No one at Arena Pharmaceuticals (ARNA) could accuse CEO Jack Lief of being a rat. In a conference call Thursday with analysts after an FDA panel rejected the drugmaker’s Lorqess diet pill due to safety concerns, Lief acknowledged that different forms of cancer had been seen in rats treated with high doses. But he stressed that “when we learned of the data, we promptly discussed it with the FDA.” But then Cowen analyst Phil Nadeau asked if the info was ever made available to the public or was the FDA briefing document (pdf) released this week the first time investors might have learned of this finding. Lief replied by saying “…we believe that (Lorqess) does not pose a cancer risk to humans at the recommended therapeutic dose…There is an immense amount of data generated in drug development. We did not, and still do not believe that the data’s relevant to humans and, as such, did not believe it was material to investors.”Complete Story » seekingalpha.com |
Novartis Halts Development of Two Drugs: Biotech's Latest Tribulations The Burrill Report submits: Novartis (NVS) said that it is discontinuing the development of two investigational compounds and will take charges of $590 million in the third quarter of 2010 as a result. The decision, it said, reflects an enhanced focus on portfolio prioritization and productivity. Novartis and its partner, Human Genome Sciences (HGSI), are stopping development of albinterferon alfa-2b, an investigational compound for the treatment of adults with chronic hepatitis C. Novartis also said it will discontinue development of Mycograb, an antifungal agent being assessed for the treatment of invasive candidiasis in adult patients. The company said the charge will be partially offset by a gain on divestment of Enablex of approximately $390 million to be recognized in fourth quarter 2010. The U.S. Food and Drug Administration has notified Johnson & Johnson (JNJ) that it would not approve the company’s application for the analgesic tapentadol without additional data. The medicine is an oral extended release tabletfor the management of moderate to severe chronic pain in adults. The FDA has not requested any new clinical studies evaluating the efficacy or safety of tapentadol extended release, but is requesting data regarding the conversion of the extended release formulation used in the clinical efficacy and safety trials to a different extended release formulation that is designed to increase mechanical resistance to breaking or crushing. Complete Story » seekingalpha.com |