About six months after Epizyme Inc. won FDA clearance of Tazverik (tazemetostat) for epithelial sarcoma (ES), the firm scored accelerated approval in the larger indication of relapsed or refractory (r/r) follicular lymphoma (FL). Specifically, U.S. regulators cleared the methyltransferase inhibitor for adults whose tumors test positive for an EZH2 mutation who have received at least two prior systemic therapies and for those with no satisfactory alternative treatment options – language that “gives physicians a lot of flexibility to use their clinical judgement in how to best prescribe” the drug, CEO Robert Bazemore noted. Read More
The worldwide option and license agreement Alpine Immune Sciences Inc. drew up with Abbvie Inc. for ALPN-101, a dual CD28/ICOS co-stimulation antagonist for treating systemic lupus erythematosus and other autoimmune diseases, heartily strengthened Alpine’s stock and supports its planned operations into 2023. Read More
Nan Fung Life Sciences is “looking to make a significant presence in the field,” said Engrail Therapeutics Inc. CEO Vikram Sudarsan, whose firm bagged a $32 million series A round led by the global investment platform of Hong Kong’s Nan Fung Group, and its support represents “a clear statement in that direction.” Read More
After 30 years of following the same rules to ensure Medicaid receives the lowest price available for prescription drugs, the U.S. Centers for Medicare & Medicaid Services (CMS) is starting to adapt those rules for the 21st century. Read More
Countries and health care providers should hope for the best but prepare for the worst as a resurgence of COVID-19 is expected in the fall, just as the influenza season hits. Read More
The U.S. District Court for the Northern District of West Virginia ruled against Biogen Inc., of Cambridge, Mass., and in favor of Mylan NV, of Hertfordshire, U.K., in a patent dispute regarding Biogen’s blockbuster multiple sclerosis drug, Tecfidera (dimethyl fumarate). Read More
Biopharmas raising money in public or private financings, including: Brickell, Catalyst, Celldex, Ideaya, Iveric, Leap, Provention, Renovion. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aligos, Beigene, Cynata, Dicerna, Epizyme, Hutchison, Linnaeus, Pear, Protagonist, TFF, Ultragenyx. Read More
