The FDA clapped a clinical hold on the IND for a clinical trial of Dyne Therapeutics Inc.’s DYNE-251 for treating Duchenne muscular dystrophy in patients amenable to skipping exon 51. The agency is asking for more clinical and non-clinical information on the therapy. A response, including data from existing and ongoing studies in the second quarter of 2022, is expected to be filed to the FDA sometime in mid-2022, Dyne said.
The U.S. Center for Medicare & Medicaid Services (CMS) opened a 30-day comment window on its proposed national coverage determination (NCD) to limit Medicare access to monoclonal antibodies targeting amyloid beta in Alzheimer’s disease (AD) only in clinical trials. Biogen Inc., clearly the target, along with its AD treatment Aduhelm (aducanumab), was among the first to respond.
The pandemic has forced pharma and biotech to be more agile to better navigate the obstacles and still find success. Supply chain gaps are part of the problem, as are clinical trial delays. Yet the industry has successfully forged ahead in the past year to produce the seven drugs Clarivate believes in the next five years will each earn more than $1 billion annually.
The deals continued to flow during day two of the J.P. Morgan Healthcare Conference. Privately held Arrakis Inc., which specializes in aiming at small-molecule RNA targets, primarily cancers, has signed onto a collaboration with Amgen Inc. that could bring in billions in future payments should it hit all the milestones and program options are exercised. Dren Bio Inc., meanwhile, will collaborate with Pfizer Inc. to develop bispecific antibodies for oncology targets. Dren could receive more than $1 billion in the deal that includes a $25 million in cash up-front payment from Pfizer.
The pandemic has forced pharma and biotech to be more agile to better navigate the obstacles and still find success. Supply chain gaps are part of the problem, as are clinical trial delays. Yet the industry has successfully forged ahead in the past year to produce the seven drugs Clarivate believes in the next five years will each earn more than $1 billion annually.
Century Therapeutics Inc.’s $3.25 billion deal with Bristol Myers Squibb Co. (BMS) was the largest of four billion-dollar-plus agreements announced Dec. 10, piggybacking on a busy week that includes the start of the 40th annual J.P. Morgan Healthcare Conference.
The hinge of the new development deal between Entos Pharmaceuticals Inc. and Eli Lilly and Co. is also the core of Entos’ business: delivering a drug without significant toxicity. Development of the cargo is only part of the story in creating safe and effective medicine, Entos CEO John Lewis told BioWorld. “You have to have a safe and effective delivery system.”
After discussions with the FDA, Applied Therapeutics Inc. said it will again delay an NDA filing for its galactosemia treatment, AT-007, until it has more time to discuss the filing with the agency.
After a six-month long trial, a jury found Teva Pharmaceuticals USA Inc., a subsidiary of Jerusalem-based Teva Pharmaceutical Industries Ltd., liable in contributing to New York state’s opioid crisis that saw thousands die.
Preliminary data from a phase IIIb study of Johnson & Johnson’s Ad26.COV2.S COVID-19 vaccine showed a homologous booster dose was 85% effective against hospitalization in participants from South Africa.
