Cullinan Therapeutics Inc. swept up ex-China rights to a multiple myeloma (MM)-targeting BCMAxCD3 bispecific T-cell engager (TCE) velinotamig from Chongqing Genrix Biopharmaceutical Co. Ltd. via a potential $712 million deal June 4. The plan is to repurpose the cancer drug to autoimmune disease.
Slightly ahead of the assigned June 23 PDUFA date, Nuvation Bio Inc. scored the U.S. FDA’s go-ahead for Ibtrozi (taletrectinib) to treat adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
What does it take to create space in a market dominated by a single player? Three challengers to Johnson & Johnson's Shockwave shared their strategies for gaining traction in intravascular lithotripsy (IVL) at the Device Talks meeting June 11 in Minneapolis.
When it comes to the U.S. biopharma market, pricing seems to be the driving focus of most congressional conversations – and government contracts. Rep. Cliff Bentz, R-Ore., hit pause on that conversation at a June 11 House subcommittee hearing on the drug supply chain, when he asked if the U.S. is sacrificing security for price.
Philochem AG’s ligand-targeting approach drew to the table Bristol Myers Squibb Co. in a potential $1.35 billion agreement granting BMS subsidiary Rayzebio Inc. exclusive worldwide rights to OncoACP3, a diagnostic and therapeutic candidate targeting prostate cancer.
Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology.
London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
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