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 […]

Broad Institute has announced that the patents granted to MIT, Harvard and Broad Institute concerning CRISPR editing of eukaryotic genomes do not interfere with patent claims filed by UC Berkeley and the University of Vienna, according to a decision handed down by the U.S. Patent Trial and Appeal Board on February 15. The decision confirms […]

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing of ABP 501, a biosimilar for Abbvie’s Humira (adalimumab). The committee recommended approval for all available indications, including moderate-to-severe rheumatoid arthritis, chronic plaque psoriasis, Crohn’s disease and ulcerative colitis. ABP 501 is the first Humira […]

Takeda Pharmaceuticals has announced it will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, for a total value of approximately $5.2 billion. The transaction is expected to close by the end of February 2017. The acquisition of Cambridge-based ARIAD adds new investigational oncology products to Takeda’s pipeline, including Brigatinib […]