The U.S. Food and Drug Administration approved Vertex Pharmaceutical Inc.’s cystic-fibrosis drug Orkambi, which could treat as many as 8,500 patients in the U. S. — but at a whopping annual wholesale cost of $259,000 per patient. The drug, a twice-daily oral tablet for patients 12 years and older, expands the company’s reach in the […]

A major French hospital group has chosen a cheap copycat version of a top-selling drug for treating its patients with rheumatoid arthritis, Crohn’s disease and psoriasis in a victory for a new type of medicine known as biosimilars.    In a document seen by Reuters, the central purchasing agency for the Assistance Publique – Hôpitaux de […]

South San Francisco, Calif.-based Genentech (RHHBY) announced today that its clinical studies of ocrelizumab compared to interferon beta-1a (Rebif) in relapsing multiple sclerosis (MS) met their primary and major secondary endpoints.   Two Phase III studies are being conducted, OPERA I and OPERA II. The primary endpoint of both studies was annualized protocol-defined relapse rate […]

June 30, 2015By Alex Keown and Riley McDermid, BioSpace.com Breaking News Staff BOSTON – Vertex Pharmaceuticals (VRTX) is anxiously waiting for regulatory approval of its newest cystic fibrosis medication Orkambi, a treatment which is widely expected to have a broad impact on the cystic fibrosis market – and a treatment widely expected to sharply boost […]

New market data is showing a renewed and ravenous demand for options tied to declines in an exchange-traded fund tracking biotech companies, according to Bloomberg data, which hit the highest level in three years last week. Biotech is continuing its scorching pace of growth, with the NASDAQ Biotechnology Index (NBI) up more than 25 percent […]

Will good news and a stock surge mean Synergy Pharmaceuticals is soon to be a target for acquisition? Some analysts think so. Synergy Pharmaceuticals (SGYP) announced the top-line results from the first of two pivotal Phase III clinical trials studying two different plecanatide treatment doses in adult chronic idiopathic constipation (CIC). Plecanatide is being studied […]

One thing about Allergan chief executive Brent Saunders is he doesn’t waste much time. After all, he was personally involved in setting up $97 billion worth of deals last year. The $66 billion acquisition of the company that used to be called Allergan by Saunders’ outfit, then called Actavis, closed in March. On Monday, Actavis changed its […]