Alexza’s lead candidate, AZ-004 is actually under FDA review with an action date schedule for October 11th 2010. We believe that their Staccato platform has the right combination of key attributes for the treatment of acute agitation that makes the product a $500M Market opportunity.
Theratechnologies (TSX:TH) announced that it has received feedback from the FDA regarding the timeline to review tesamorelin’s New Drug Application for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The FDA has indicated that the review is progressing well. The Company now expects to have an official response in the fourth quarter of 2010. Theratechnologies and the Agency continue the positive and constructive dialogue regarding the regulatory process for tesamorelin.
Below is a list of the companies that made news in the healthcare sector on Monday, July 5, 2010. China Medical Technologies, Inc. (NASDAQ:CMED), a leading China-based advanced in-vitro diagnostic (“IVD”) company, today announced that it will report its unaudited financial results for the first fiscal quarter (“1Q FY2010″) ended June 30, 2010 before the [...]
Below is a list of the companies that made news in the healthcare sector on Friday, July 2, 2010. Cepheid (NASDAQ:CPHD) after the market close today announced that the company is initiating a recall of all lots of Xpert® MRSA/SA BC (blood culture) product. The recall is a corrective action, which does not require return [...]
Below is a list of the companies that made news in the healthcare sector on Wednesday, June 30, 2010. Dendreon Corp. (NASDAQ:DNDN) fell sharply in after-hours trading after the CMS (Center for Medicare & Medicaid Services) issued a report regarding coverage on cancer drug Provenge. The report on the CMS website said: “We are opening [...]
Below is a list of the companies that made news in the healthcare sector on Wednesday, June 30, 2010. Cubist Pharmaceuticals, Inc.(NASDAQ:CBST), a leading acute care therapeutics company, today after the market close announced that the recently-completed Phase 2 study of CXA-101, a novel cephalosporin, compared to ceftazidime for the treatment of complicated urinary tract [...]
Below is a list of the companies that made news in the healthcare sector on Monday, June 28, 2010. Javelin Pharmaceuticals, Inc. (AMEX:JAV) soared after the bell today after Hospira, Inc. (NYSE:HSP) announced its intention to complete the tender offer by Discus Acquisition Corporation, a wholly owned Hospira subsidiary, for all outstanding shares of the [...]
The following companies made the news for the Health Care Industry on Monday, June, 28, 2010 Cardiome, (NASDAQ:CRME): BRINAVESS, Intravenous or IV Vernakalant announced, EMA issued positive opinion for marketing approval for conversion of recent onset atrial fibrillation to sinus rhythm in adults, marketing authorization is expected later this year and will include 27 EU [...]
Below is a list of the companies that made news in the healthcare sector on Sunday, June 27, 2010. Biodel Inc. (NASDAQ:BIOD) announced Friday after the bell the final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 [...]
Below is a list of the companies that made news in the healthcare sector on Thursday, June 24, 2010. MannKind Corporation (NASDAQ: MNKD) after the bell today reported that a study, showing that AFREZZA Inhalation Powder, combined with basal insulin is comparable to standard insulin therapy in controlling post-meal blood sugar levels in adult patients [...]
