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Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
FDA
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
As we near the end of second quarter of 2024, the initial public offerings among biotechs have slowed, but the market is still going strong.
Amid shortages of its Mounjaro and Zepbound blockbuster drugs, Eli Lilly on Friday said it is investing an additional $5.3 billion in its production site in Lebanon, Indiana, to boost output of their active ingredient.
Aiming to compete in the lucrative weight-loss drug market, Zealand Pharma on Thursday posted topline results showing its dapiglutide led to only a slight weight reduction in low doses.
CEO Pascal Soriot on Tuesday heralded a “new era of growth” for AstraZeneca with plans to launch 20 new medicines in six years. He’s delivered before but can he do it again?
Full data from the FLOW study show that Novo Nordisk’s top-selling GLP-1 receptor agonist semaglutide can significantly reduce the risk of death by 20% in diabetes patients with chronic kidney disease.
After selling off its oral TYK2 blocker to Takeda for $4 billion, Nimbus Therapeutics has posted strong early-stage data for its other clinical candidate, NDI-101150, in solid tumors.
Phase I/II data for Regeneron Pharmaceuticals’ costimulatory bispecific antibody were disappointing, with only one complete response when used as a combination treatment with Libtayo for solid tumors.
Johnson & Johnson’s radiopharma candidate JNJ-6420 returned mixed results in an early-stage study, demonstrating strong biochemical and radiographic response but also resulting in four patient deaths.
Tango Therapeutics reported Thursday that solid tumor patients who stayed in the Phase I study for more than eight weeks developed Grade 3 and 4 liver function abnormalities.
Orna Therapeutics announced Thursday it is acquiring ReNAgade Therapeutics, which launched in May 2023 with $300 million in Series A financing and is on BioSpace’s NextGen Class of 2024 startups to watch this year.