Geron wins long-sought drug approval; Califf talks China, GLP-1s at BIO
Today, several brief updates from BioPharma Dive Reporter Gwendolyn Wu, who spent this week attending BIO’s annual meeting in San Diego, as well as notes on Geron, AbbVie and Deerfield Management.
Food and Drug Administration Commissioner Robert Califf, speaking on a Wednesday panel, told BIO president John Crowley that he did not want to see the pharmaceutical industry “completely dependent” on China, an issue that’s been in focus as Congress considers legislation targeting certain Chinese companies. “There could be a catastrophic thing like an earthquake or a geopolitical war, so you want to have a distributed supply chain that is resilient in case something goes wrong,” Califf said. — Gwendolyn Wu
In the same conversation, Califf described himself as a “radical advocate” for the GLP-1 drugs the FDA has approved for obesity. But, true to form, he said more should be done in preventive care. “I do have sort of nightmares that my great grandchildren are going to read about a country called America where, on average, people are gaining a pound per year because of their eating, and instead of fixing that, this country decided to invent a class of drugs that cost $20,000 a year to reverse basic eating habits,” he said. — Gwendolyn Wu
Geron, a 34-year-old biotechnology company, won its first drug approval Thursday when the Food and Drug Administration cleared Rytelo for myelodysplastic syndromes, or MDS. The FDA OK came after clinical setbacks for Geron and positions the therapy to challenge Bristol Myers Squibb’s Reblozyl in treating people with lower-risk MDS and anemia. Notably, the FDA didn’t put a warning for hematological side effects on the drug’s label as analysts had suspected. That could boost buyout interest in Geron, as well as in Rytelo’s launch, Stifel analyst Stephen Willey wrote in a research note. Shares climbed by more than 20% Friday. — Ben Fidler
Shares of Shionogi fell sharply in trading on the Tokyo stock exchange Friday, possibly due to an announcement that the company is considering a “new development strategy” for an obesity drug it’s developing. In an R&D presentation Friday, the company revealed preliminary data from Phase 2 testing showing treatment with its drug led to less than 5% weight loss among study participants. As a result, Shionogi may develop it in combination with other therapies. — Ned Pagliarulo
AbbVie spent $10 billion last year to acquire ImmunoGen, drawn in large part to the potential of the antibody-drug conjugates the biotechnology company had developed. One of those, an ovarian cancer treatment called Elahere, has now succeeded in another study, AbbVie said Thursday. The drug shrank tumors in half of treated participants, who had platinum-sensitive ovarian cancer. Full data will be presented at an upcoming medical meeting. — Ned Pagliarulo
Frank Nestle, the former chief scientific officer and head of research at Sanofi, is starting a new career at the biotech company creator Deerfield Management. Nestle, who had joined Sanofi in 2016, oversaw the French drugmaker’s rise in immunology as it built a pipeline beyond its top-selling Dupixent. In addition to serving as CEO of Deerfield Discovery and Development, Nestle will join the firm’s therapeutics team as a partner. — Gwendolyn Wu
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