Ben Fidler

3 weeks ago | biopharmadive.com | Ben Fidler

Over the past decade, several dozen cell and gene therapies have reached market in the U.S., bringing with them the promise of long-lasting benefits for serious diseases. Peter Marks’ fingerprints are all over those approvals. As head of the Food and Drug Administration’s Center for Biologics Evaluation and Research since 2016, Marks oversaw the clearances of the first gene therapy, the first cellular treatment for cancer and the first CRISPR gene editing medicine, among others.

3 weeks ago | biopharmadive.com | Ben Fidler

Bluebird bio on Friday received a new buyout offer that surpasses a take-private bid the pioneering gene therapy developer received last month. In a short statement, Bluebird confirmed Ayrmid Ltd., the parent company of cell therapy developer Gamida Cell, has offered to buy the company in a deal valuing it at about $45 million.

3 weeks ago | biopharmadive.com | Ben Fidler

Today, a brief rundown of news involving Novo Nordisk and DBV Technologies, as well as updates from Arbutus Biopharma, Bicycle Therapeutics and CRISPR Therapeutics that you may have missed. Novo Nordisk on Friday licensed an experimental medicine from Lexicon Pharmaceuticals that it intends to develop for obesity and associated metabolic disorders. Lexicon is receiving $45 million in cash upfront, which it will use to pay down debt, according to a regulatory filing.

4 weeks ago | biopharmadive.com | Ben Fidler

Nkarta is laying off a third of its workforce, and more than half its executive team, in a bid to survive long enough to see if an experimental cell therapy it’s developing will show promise against multiple autoimmune conditions. Nkarta revealed the initiative alongside fourth quarter earnings on Wednesday. The cuts will impact 53 positions, freeze some future hires and enable it to operate into 2029.

4 weeks ago | biopharmadive.com | Ben Fidler

The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease Prader-Willi syndrome, a long-awaited decision that follows an unorthodox pitch from the drug’s developer. The agency oncleared Vykat XR, from biotechnology company Soleno Therapeutics, for this hyperphagia that’s caused by Prader-Willi.