Abbvie Inc. is buying out Cerevel Therapeutics Inc. for $45 per share in cash, adding up to an equity value of about $8.7 billion. Cambridge, Mass.-based Cerevel brings to Abbvie, of North Chicago, a neuroscience pipeline of clinical-stage and preclinical prospects that could apply across several diseases, including schizophrenia, Parkinson's disease, and mood disorders. Cerevel's late-stage asset emraclidine, a positive allosteric modulator of the muscarinic M4 receptor, could become a best-in-class, next-generation antipsychotic for schizophrenia, the companies said. Shares of Cerevel (NASDAQ:CERE) were trading midday at $41.51, up $4.58, or 12%. Abbvie’s stock (NYSE:ABBV) was selling for $147.85, up $1.47.

‘Oh when the government goes marching in’ a rising US threat

After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have feared to trod. It released a proposed framework today to lay the ground for federal agencies to use price as a reason, under the Bayh-Dole Act, to march in on patent rights protecting taxpayer-funded drugs and other inventions, including medical devices. The announcement received instant backlash and opened the possibility to legal challenges. “The Biden administration does not have the legal authority for this use of march-in rights,” said Sen. Bill Cassidy (R-La.). “Prior administrations of both parties have all agreed on this point, as have the bipartisan senators who wrote the law.”

Three phase IIIs: BMS, Merck and Sanofi release new cancer data

Three giants have produced new phase III study data for their already approved, big name therapies. Two were positive and the third was stopped for futility. Bristol Myers Squibb Co.’s Opdivo (nivolumab) plus Yervoy (ipilimumab) was compared to chemotherapy as a first-line treatment for treating microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer and the combination met the dual primary endpoint of progression-free survival. Sanofi SA’s Sarclisa (isatuximab) hit its primary endpoint of progression-free survival in patients with newly diagnosed multiple myeloma who are not eligible for a transplant. The anti-CD-38 therapy was used in combination with standard-of-care bortezomib, lenalidomide and dexamethasone. Merck and Co. stopped its phase III study of the anti-PD-1 therapy Keytruda (pembrolizumab) in metastatic squamous non-small-cell lung cancer on the recommendation of an independent data monitoring committee. Keytruda plus Lynparza (olaparib) did not show an improvement in overall survival, which was one of the study’s primary endpoints.

Post-pandemic inspection load an ongoing struggle for FDA

The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities. The backlog of inspections and the increasing need for specialization among members of the agency’s field inspection force are combining to make it difficult for the FDA to catch up, a problem that is likely to ease only after a few more fiscal years.

FDA tells industry to get serious about UDI compliance

The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Thomas noted that UDI compliance failures are starting to populate FDA warning letters and noted that these warning letter citations are meant as “a shot across the bow” to industry.

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