Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. Legend Biotech is taking a close at its business as M&A has emerged as an option. A large number of missing adverse events in South Korea triggered a full-scale check-up during the FDA's review of Amgen's Imdelltra. And more.
1. Merck pays $700M for bispecific, spying autoimmune opening and chance to challenge Amgen in cancer
Merck is paying $700 million upfront and committing up to $600 million in milestones to obtain global rights to Curon Biopharmaceutical’s CD19xCD3 bispecific candidate CN201. The Chinese biotech has presented early-stage data for the drug in blood cancers, and Merck is also interested in the T-cell engager’s potential in autoimmune diseases.
2. Legend Biotech CEO takes 'close look at business' amid geopolitical risk, M&A rumor
Regarding the possibility of a buyout, Legend Biotech’s leaders have been taking a close look at the business, CEO Ying Huang, Ph.D., said during a conference call. The company has evaluated the draft BIOSECURE Act and engaged with lawmakers and decided it’s not too concerned about being targeted by the legislation. These uncertainties come as Legend and partner Johnson & Johnson are busy growing their CAR-T therapy Carvykti.
3. To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events
Amgen’s original FDA application for the newly approved small cell lung cancer drug Imdelltra had “a large number” of underreported adverse events, the agency noted in its review document. Missing adverse event reports were uncovered during an FDA inspection of a clinical trial site in South Korea. At the FDA’s request, Amgen’s examined all five Korean sites involved in the DeLLphi-301 study and returned 109 missing adverse events, which prompted an all-inclusive reevaluation.
Ajinomoto Bio-Pharma Services is laying off 71 staffers in San Diego. The job cuts are part of the Japanese CDMO’s consolidation of its drug substance production unit after last year’s acquisition of viral vector and plasmid specialist Forge Biologics. The move will allow the San Diego site and another plant in Ohio to focus on their respective areas of expertise, the company said.
Other News of Note
5. Startup Vivint Pharma to spend $48M to build injectables plant in India
6. Merck KGaA, NSG BioLabs team up to support biotech R&D in Singapore (release)
7. Astellas' CLDN18.2 drug Vyloy wins UK nod for stomach cancer (release)