A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. Read More
Roche Holding AG took an interest in immunometabolism specialist Rheos Medicines Inc. even before its March 2018 launch. Now, less than two years later, it has tapped Cambridge, Mass.-based company, founded by Third Rock Ventures, to identify and develop an undisclosed number of new therapies for autoimmune and inflammatory disease. Read More
Turnstone Biologics Inc. has found a major backer for its preclinical vaccinia-based oncolytic virus platform for cancer immunotherapy. Takeda Pharmaceutical Co. Ltd. is paying $120 million in up-front, near-term milestones and equity investment and could pay $900 million more in development, regulatory and commercial milestones to enter a strategic alliance with the New-York-based firm. Read More
DUBLIN – Gene therapy firm Freeline Therapeutics Ltd. secured the first $40 million tranche of an $80 million series C round from its founding investor and principal shareholder Syncona plc to generate further data from its two clinical-stage programs, in hemophilia B and Fabry disease, to fund expansion of its team and to continue the ongoing buildout of its manufacturing operations in Munich. Read More
One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides. Read More
A Chinese study has established a previously unknown direct mechanistic link between elevated mechanical tension caused by impaired alveolar regeneration and progressive idiopathic pulmonary fibrosis (IPF), highlighting a pathogenic mechanism that may underlie fibrosis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
