FDA Approvals for Alkermes & Vertex Among the NE Life Sciences News

Image licensed by Depositphotos.com/Christian Delbert.

News of FDA drug approvals shone the spotlight on some New England biotechs this week.

—Waltham, MA-based Alkermes (NASDAQ: [[ticker:ALKS]]) and San Diego-based Amylin Pharmaceuticals(NASDAQ: [[ticker:AMLN]]) won FDA approval for their injectable diabetes drug exenatide once-weekly (Bydureon). This was their third time seeking clearance for the drug, which uses technology from Alkermes to last long enough in the bloodstream to turn it into a once-weekly injection

—Additionally, the FDA cleared a drug developed by Lexington, MA-based Curis and its partner Genentech as treatment for a common form of skin cancer called basal cell carcinoma. The drug, vismodegib (Erivedge), is the first approved product for Curis.

—They say good news comes in threes. Cambridge-based Vertex Pharmaceuticals also got a faster-than-expected FDA OK to start selling its drug ivacaftor (Kalydeco) as a treatment for a rare form of cystic fibrosis. That’s the second drug approval for Vertex (NASDAQ: [[ticker:VRTX]]), which also sells a treatment for hepatitis C. Bonnie Ramsey, one of the key people involved in developing the drug, talked to my colleague Luke about the implications of the approval.

—But there was some bad news, too: A week after reporting data that its pancreatic cancer treatment saridegib (IPI-926) showed some success in a small study, Infinity Pharmaceuticals (NASDAQ: [[ticker:INFI]]) halted a bigger, mid-stage clinical trial of the drug when it showed patients were living longer in the placebo group. The Cambridge, MA-based company’s shares fell more than 30 percent after the news last Friday.

Author: Erin Kutz

Erin Kutz has a background in covering business, politics and general news. She holds a bachelor’s degree in journalism from Boston University. Erin previously worked in the Boston bureau of Reuters, where she wrote articles on the investment management and mutual fund industries. While in college, she researched for USA Today reporter Jayne O’Donnell’s book, Gen Buy: How Tweens, Teens and Twenty-Somethings Are Revolutionizing Retail. She also spent a semester in Washington, DC, reporting Capitol Hill stories as a correspondent for two Connecticut newspapers and interning in the Money section of USA Today, where she assisted with coverage on the retail and small business beats. Erin got her first taste of reporting at Boston University’s independent student newspaper, as a city section reporter and fact checker and editor of the paper’s weekly business section.