Sanofi and Regeneron Pharmaceuticals announced that the FDA has approved Dupixent, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD), a form of eczema, whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent is a human monoclonal antibody […]

Vertex Pharmaceuticals Incorporated has announced results from two Phase 3 studies of the tezacaftor/ivacaftor combination treatment that showed statistically significant improvements in lung function in people with cystic fibrosis (CF) ages 12 and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The 24-week EVOLVE study evaluated the combination treatment […]

The Pacific Coast Business Times is reporting that on March 22, Amgen notified nearly 500 employees at their Thousand Oaks facility that they will be re-assigned, relocated, or laid off over the next year and a half. The reassigned employees will be transferred to a new facility in Tampa Bay or to R&D in Cambridge, […]

As reported by Robert Weisman in The Boston Globe, following a report that Burlington-based Flexion Therapeutics is negotiating a sale to French drug giant Sanofi, Flexion shares rose more than 33 percent. Spokeswomen for Sanofi and Flexion — which has a promising knee pain drug up before US regulators — declined to comment. The purchase […]

The FDA has granted accelerated approval to Bavencio (avelumab) for the treatment of metastatic Merkel cell carcinoma (MCC). This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer, and EMD Serono’s first cancer drug launch. The drug has been approved for adults and pediatric patients 12 years and older, […]

As reported by Robert Weisman in The Boston Globe, Biogen’s patent on its top-selling multiple sclerosis treatment, Tecfidera, was upheld by a legal ruling in which the U.S. Patent Trial and Appeal Board rejected a challenge by Texas hedge fund manager Kyle Bass. Bass has been working for years to invalidate key intellectual property rights […]

Waltham-based Arrakis Therapeutics has completed a $38 million Series A financing led by Canaan Partners with participation by Pfizer, Celgene, and biotech industry leader Henri Termeer, among others. Arrakis was founded with a vision to create a proprietary, transformational discovery platform that identifies small-molecule drugs that act directly on disease-causing RNA.  The company was established […]

Vertex Pharmaceuticals has agreed to acquire CTP-656 from Lexington-based Concert Pharmaceuticals. CTP-656 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to assist in treating the underlying cause of cystic fibrosis (CF). As part of the agreement, Vertex will pay Concert $160 million in cash for worldwide development and commercialization […]

Regulators in the European Union and the United States have agreed to recognize inspections of manufacturing sites for human medicines performed by the other agency. Each year, authorities from the EU and the FDA inspect the same production sites in the US and EU. Under the new agreement, EU and US regulators will rely on […]

Massachusetts will be a partner in the nation’s first manufacturing innovation institute in biopharmaceutical manufacturing. The $250 million biopharmaceutical innovation institute is a national, public-private partnership, with federal matching funds provided by the US Department of Commerce’s National Institute of Standards and Technology. Massachusetts will anchor the northeastern node for the institute, which will be […]