The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy. Read More
A discovery-stage company founded 10 years ago and focused on developing a PINK1 activator for Parkinson’s disease and other indications is now under the umbrella of Abbvie Inc. through an acquisition potentially worth $655 million. North Chicago-based Abbvie paid $110 million at closing for San Francisco-based Mitokinin Inc., but the deal also includes up to $545 million in potential payments upon hitting development and commercial milestones related to the PINK1 (PTEN-induced kinase 1) program. On top of that, Mitokinin shareholders are entitled to tiered royalties based on net sales. Read More
Dimerix Ltd. has out-licensed lead candidate DMX-200 to Advanz Pharma Corp. for focal segmental glomerulosclerosis (FSGS) in a carve-out deal that grants commercialization rights to Advanz in the European Union, the U.K., Switzerland, Canada, Australia and New Zealand. Read More
Unlocking the future of drug development often means removing obstacles that currently stand in the way. Reimbursement is one of those obstacles, as is keeping humans deeply involved as innovators and patients even as artificial intelligence (AI) increases its role. A panel of developers spoke about what they anticipate will be the biggest changes in the coming 10 to 20 years at the BioFuture 2023 conference in New York on Oct. 5. A common theme was reforming the structure of reimbursements, which has traditionally been a problem in the digital therapeutic realm, according to Eric Elenko, chief innovation and strategy officer at Puretech Health plc. Read More
Biopharma companies and industry advocates received the message the U.S. FTC intended to send when it broke new antitrust ground earlier this year in challenging Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. Now they’re uniting to send a message of their own – in the guise of an awareness campaign showing that the FTC’s new approach to M&A reviews and antitrust enforcement will undermine the ecosystem responsible for innovative and important therapies the world over. Read More
Five life science firms from the U.S., Asia and Germany have banded together to launch a Singapore biotech “incubator” called 65LAB in hopes of finding, funding and accelerating promising research from Singapore’s leading academic institutions to commercialization. Read More
The US FDA is offering sponsors of certain drugs and biologics more agency access as part of a pilot program that will be launching in January 2024 with the mission of accelerating the development of new therapies for rare diseases. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Ardelyx, Biomx, Blue Earth, Clearside, Freeline, Gain, Moderna, Ocular, Oncoinvent, Regenxbio, Rejuvenate, Starton, Swanbio, Vedanta, Vertex, Veru. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bayer, Clene, Dyadic, Emergex, Impel, Medicinova, Odyssey Health, Oragenics, Sanofi, Sosei, Twist, Uniqure, Verily, Voltron. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acrotech, Bioxcel, Inhibikase, Novavax, Noxopharm, Takeda, Theratechnologies, Transcenta, Vedanta. Read More
