More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.
C4 Therapeutics Inc.’s degrader-antibody conjugate (DAC) strategy gathered more steam with a new collaboration between the firm and Roche AG that brings $20 million up front with the potential for more than $1 billion in discovery, regulatory and commercial milestone payments.
In a decision that maintains the regulatory status quo, the U.S. FDA denied a petition from Harrison.ai to partially exempt certain diagnostic/detection AI devices from premarket review so long as the manufacturer has 510(k) clearance for a device in a similar category and a robust postmarket plan.
Syneron Bio is emerging as one of the most heavily backed new entrants in the macrocyclic peptide space, raising more than $250 million in venture funding and securing a multibillion-dollar deal with Astrazeneca plc as it builds a platform spanning several of the most competitive frontiers in drug development.
The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.
Founded amid the booming next-generation antibody-drug conjugate (ADC) space, Sidewinder Therapeutics Inc. has emerged from stealth with an oversubscribed $137 million series B round and plans to advance a lead program into the clinic in 2027.
Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX (mFOLFIRINOX), which is being administered in combination with lead compound narmafotinib (AMP-945), a focal adhesion kinase inhibitor.
German company Tubulis GmbH, which emerged with a $12.3 million series A round and a next-generation antibody-drug conjugate (ADC) platform about six years ago, has commanded up to $5 billion in a buyout offer from Gilead Sciences Inc.
Stipple Bio Inc. raised $100 million in a series A financing to support progression of the company’s lead drug, STP-100, an antibody-drug conjugate that binds an undisclosed target, and the company’s Pointillist discovery platform.
Swedish startup One-carbon Therapeutics AB is going after solid tumors with an approach that looks similar to synthetic lethals to some people, and to chemotherapy to others. But One-carbon CEO Ana Slipicevic said that TH-9619, the company’s first-in-class inhibitor of the enzyme MTHFD1/2, is neither of those things.