A $2 billion deal with Blackstone Group Inc. is setting Alnylam Pharmaceuticals Inc. up so that it doesn’t have worry about future equity financing and instead can concentrate on RNAi R&D. Read More
Following a priority review, partners Astrazeneca plc and Merck & Co. Inc. have gained a green light from the FDA for U.S. marketing of the oral MEK1/2 inhibitor Koselugo (selumetinib), the first FDA-approved treatment for the rare genetic disorder neurofibromatosis type 1 (NF1). Read More
In order to redirect health care resources and protect patients during the COVID-19 pandemic, many drug companies have paused enrollment in some or all of their ongoing clinical trials. But patients still in the studies need to be followed for safety and efficacy, creating challenges for the industry. Read More
Stony Brook Medicine has launched an FDA-approved, randomized investigational new drug (IND) trial to determine whether plasma from people who have recovered from COVID-19 can aid in the recovery of patients currently fighting the disease. Chembio Diagnostics Inc.'s COVID-19 rapid serological point-of-care test will be used to identify potential plasma donors. Read More
LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture. Read More
Princeton, N.J.-based Urogen Pharma Ltd. is transforming itself into a commercial operation in anticipation of an FDA approval for UGN-101 this week. Wall Street also apparently expects a positive decision by the April 18 PDUFA date, as listed in BioWorld’s Drugs on Deck record. Urogen’s stock (NASDAQ:URGN) has climbed 40% since the month began, and 11.31%, or $2.41, on April 13, closing out the day at $23.71. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Aslan, Bausch Health, Kolon, Lilly, Nextcure, Prolynx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 89bio, Alimera, Cannabics, Celltrion, CNS, Coherus, Connectyx, Enlivex, Fulcrum, Gilead, La Jolla, Medgenome, Ocular, Orgenesis, Pluristem, Redhill, Tamir, Thermogenesis, Vaxil, WPD. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Arch, Arcturus, Ascletis, Astrazeneca, Athersys, Beigene, Can-Fite, Fennec, Hope, Merck, Predictive Biotech, Proteostasis, Ridgeback. Read More
