Bristol-Myers lassos the next big thing in I/O, grabs ‘214 rights in a record $3.6B deal with Nektar
After figuring for days in a swirling mix of rumors about a possible buyout, Nektar Therapeutics $NKTR is putting an end to the buzz with a record, multibillion-dollar partnership deal with Bristol-Myers Squibb for a minority share of its early-stage immuno-oncology drug NKTR-214.
Roche pens $1.9B deal to buy oncology data firm Flatiron
Roche has struck a $1.9 billion deal to acquire Flatiron Health. The takeover gives Roche ownership of the cancer software and real-world evidence that turned Google Ventures-backed Flatiron into a rising star.
Flatiron built its business around oncology-focused electronic health record (EHR) software and a repository of real-world cancer evidence. The software has gained traction and given Flatiron links to more than 250 community oncology practices, a network that could prove useful to Roche’s clinical trial unit. But the Big Pharma pointed to the real-world evidence as a key driver of the deal.
Merck just dashed the last remaining hopes for its industry-leading BACE drug for Alzheimer’s
The Alzheimer’s field is keeping its perfect record for failure in pivotal Phase III studies.
Merck today scrapped the last remaining Phase III study of its leading BACE therapy verubecestat, the second of two collapsed studies, after independent monitors concluded that the drug wasn’t working for early-stage, prodromal patients.
The FDA raises hopes for Alzheimer’s drugs with a new set of draft rules. But are they going too far?
For years now the gold standard for R&D in Alzheimer’s has focused on generating convincing evidence that any new therapy being studied could slow the cognitive decline of patients and help preserve their ability to perform the kind of daily functions that can keep a patient independent for a longer period of time.
FDA Grants EAP Designation to Guardant’s NGS-based Liquid Biopsy
Guardant Health Inc. (Redwood City, Calif.) said FDA granted Expedited Access Pathway (EAP) designation to its Guardant360 assay, a comprehensive next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer. The company plans to submit a PMA to FDA for the assay by year end.
