Gilead Sciences Inc. received a positive endorsement Thursday from a panel of FDA advisors for one of its HIV treatments and will likely receive another good review Friday, according to analysts. (AP, 5/11/12)
The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS. (Boston Globe, 5/10/12)
For the second time in less than three months, an expert panel convened by the US Food and Drug Administration voted to recommend approval of a prescription weight loss drug that had previously been rejected because of safety concerns: Lorcaserin (Lorqess) was approved Thursday by an 18 to 4 vote with 1 abstention for its ability to help overweight people shed pounds with few apparent side effects. (Boston Globe, 5/10/12)
GlaxoSmithKline PLC has made an offer to take over U.S. drug maker Human Genome Sciences Inc. which values the company at nearly $2.6 billion. GlaxoSmithKline, which has profit-sharing agreements with HGS on three drugs but a minimal shareholding, said Wednesday it is offering $13 cash per share for the company. A private offer last month by GSK at the same price was rejected by HGS management last month. (Boston Globe, 5/9/12)
Federal health advisers said Wednesday that a first-of-a-kind drug from Pfizer appears to be safe and effective for patients with rheumatoid arthritis, though they recommended follow-up studies to gauge the pill’s long-term side effects. The Food and Drug Administration’s panel of arthritis experts voted 8-2 in favor of Pfizer’s tofacitinib for patients who have not responded to one or more other drugs. The FDA is not required to follow the group’s advice, though it often does. A final decision is expected in August. (Boston Globe, 5/9/12)