Untreated HIV is a near-certain death sentence – but not quite a certain one. Roughly 1 in 300 HIV-infected individuals is able keep the virus in check without any medical treatment. Read More
The biotech industry is hoping the Supreme Court will do what Congress hasn't been able to do – give companies a fighting chance against class-action shareholder lawsuits claiming "fraud on the market." Read More
Detailed results from GlaxoSmithKline plc's Harmony 6 and Harmony 7 Phase III trials of albiglutide in Type II diabetes at 52 and 32 weeks presented at the American Diabetes Association Meeting in Philadelphia showed mixed results compared to positive top-line Harmony 6 results previously reported, and results consistent with a previously reported primary endpoint miss for Harmony 7. Read More
With its diabetes drug lixisenatide already undergoing regulatory review in Europe, Sanofi SA disclosed Monday, during the American Diabetes Association (ADA) meeting in Philadelphia, that it has now filed for regulatory approval in Japan. Read More
Genentech Inc. said it will be able to meet demand for newly approved Perjeta (pertuzumab), which it plans to roll out within the next two weeks, though the San Francisco-based biotech acknowledged it will have to resolve a manufacturing issue that could affect future supplies of the HER2-positive breast cancer drug. Read More
• Lorus Therapeutics Inc., of Toronto, completed a private placement of 20.6 million units, priced at C$0.32 each (US$0.31), raising gross proceeds of C$6.6 million. Read More
• Gilead Sciences Inc., of Foster City, Calif., said the FDA extended the PDUFA date to Sept. 14 for the priority review of Truvada (emtricitabine/tenofovir disoproxil fumarate) to prevent HIV infection in high-risk adults. Read More
• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said that it will embark on two new Phase III efficacy trials of LibiGel, a testosterone therapy for female sexual dysfunction, and that it will continue ongoing LibiGel Phase III cardiovascular and breast cancer safety studies. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, reported results from a post-hoc analysis testing DPP-4 inhibitor Tradjenta (linagliptin) on albuminuria in patients with Type II diabetes who had early diabetic nephropathy, with data showing a 29 percent reduction in a urinary albumin-to-creatinine ratio with linagliptin plus angiotensin-converting enzyme inhibitors (ACEs) and angiotensin receptor blockers (ARBs) vs. ACEs/ARBs alone at 24 weeks. Read More
• Grifols SA, of Barcelona, Spain, said Phase I data published in the Journal of Thrombosis and Haemostasis demonstrated good safety and tolerability for investigational therapy plasmin in treating patients with acute peripheral atrial occlusion. Read More
