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).
Three years after litigation started over technology used in an mRNA vaccine for COVID-19, Biontech SE is acquiring its adversary, Curevac NV, through an all-stock transaction valued at about $1.25 billion. The amount is lower than the $3 billion in backpay Curevac could win through the lawsuit if a low mid-single-digit royalty were awarded, Evercore ISI analysts Jon Miller and Umer Raffat said. But the legal uncertainty has weighed heavily on the company, which shed 30% of its workforce last July and sold off rights to two of its infectious disease vaccines.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbsiko, Alys, Gilead, Innoviva, Jazz, Merck, Outlook, Renibus, Unicycive, Vivavision, X4.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioduro-Sundia, Curadev, Deepcure, Grifols, Medicovestor, Recursion, Sanyou, Silicogenix, Synaptixbio, XL-protein.
New hires and promotions in the biopharma industry, including: Biorestorative, Cervomed, Cristcot, Day One, Devonian, Enhanced Genomics, Fibrobiologics, Fibrogen, Idorsia, Lyell, Microbiotica, Neurocrine, Tevard.
The U.K. government has doubled the rate that pharmaceutical companies must repay on sales of branded drugs, under the statutory rebate scheme, to a record 31.3%. Only 1-2% of total sales of branded drugs fall under the statutory scheme, but the increase is seen as a sign that an ongoing review of the voluntary scheme is not going well.
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