The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is taking up the matter of Lumakras (sotorasib), Amgen Inc.’s KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer (NSCLC) after at least one systemic therapy. ODAC is investigating claims made in briefing documents that the phase III confirmatory Codebreak 200 study with Lumakras in NSCLC was hobbled by “systemic bias.” Shares of Thousand Oaks, Calif.-based Amgen (NASDAQ:AMGN) were trading midday at $265.58, up 14 cents.

Abbvie buying Mitokinin and its PINK1 activator for Parkinson’s

A discovery-stage company founded in 2013 is the target of a potential $655 million acquisition by Abbvie Inc. The North Chicago-based company offered $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 program. On top of that, there are tiered royalties based on net sales. Abbvie first signed an exclusive option to acquire the company in March 2021. The triggering event was to be the completion of IND-enabling studies of Mitokinin’s lead drug, a selective PINK1 activator for Parkinson’s disease. The drug, MTK-458, also may have broad application across other diseases, such as Huntington’s, Alzheimer’s and aging conditions that involve mitochondrial dysfunction.

Dimerix out-licenses phase III FSGS candidate to Advanz in $144M carve-out deal 

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. Dimerix, of Melbourne, Australia, retains all rights to commercialize DMX-200 outside of these territories. The company’s stock on Australia’s Securities Exchange (ASX:DXB) shot up 154% on news of the deal.

BioFuture 2023: Keeping the human touch in an AI world

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 as artificial intelligence 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 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 officer at Puretech Health plc.

Biopharma unites to remind US FTC that M&As are the PULSE of innovation

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 acquisition of Horizon Therapeutics plc. And 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 many of the world’s most innovative and important therapies. “Policymakers and regulators should take great caution in adopting antitrust policies that pose a fundamental disruption to the very essence of partnership that brings patients the innovative and breakthrough medicines they need,” said Karen Kerrigan, president and CEO of the Small Business & Entrepreneurship Council, a member of the new Partnership for the U.S. Life Science Ecosystem (PULSE).

Searching Singapore’s top universities for biotechs, 65LAB offers investment of $1.5M

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. Kickstarted by the Menlo Park, Calif.-based venture capital firm Lightstone Ventures and the Hamburg, Germany-based drug discovery and development firm Evotec SE, 65LAB acts as a “unique vehicle” for company creation in the area, Lightstone said on Oct. 5.

US FDA STARTs pilot to accelerate rare disease therapies

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 with the mission of accelerating the development of new therapies for rare diseases. In addition to the formal FDA meetings already available, sponsors selected for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program will receive frequent advice and regular ad-hoc communication with FDA staff to address product-specific development issues such as trial design, choice of control group and fine-tuning the choice of patient population.

Also in the news

Abbvie, Acrotech, Aditxt, Akamis, Akero, Alx, Ardelyx, Bayer, Biomx, Bioxcel, Blue Earth, Clearside, Dermavant, Dyadic, Emergex, Freeline, Gain, Impel, Inhibikase, Medicinova, Mithra, Moderna, Novartis, Novavax, Noxopharm, Ocular, Odyssey Health, Oncoinvent, Oragenics, Regenxbio, Rejuvenate, Roche, Sosei Heptares, Starton, Swanbio, Takeda, Theratechnologies, Transcenta, Twist, Uniqure, Vedanta, Verily, Vertex, Veru, Zynerba