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Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
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With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
With an IPO raise of $625 million, Kailera Therapeutics now holds the new record for the largest public market debut.
After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window slammed shut.
As Novo Nordisk cuts 9,000 people from its organization in a restructuring effort, BioSpace looks back on the Danish pharma company’s rise.
These 27 markets, comprising countries across Asia, Europe and South America, together contributed some 12% of Lundbeck’s earnings in 2024.
Jefferies analysts expect a regulatory filing for rocatinlimab later this year, with a product launch in 2026.
Cullinan Therapeutics and Taiho Oncology’s zipalertinib elicited promising response rates in two mid-stage studies of non-small cell lung cancer patients with typical and uncommon EGFR mutations.
Former CDC director Susan Monarez and former chief medical officer Debra Houry will appear in front of the Senate HELP Committee on Sept. 17.
Novo Nordisk also lowered its full-year profit growth guidance in connection with the restructuring effort. The pharma now anticipates operating profit to grow from 4% to 10%, down from its prior projection of 10% to 16%.
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
Four Los Angeles County life sciences projects are receiving funding to support goals that include adding jobs, creating multitenant facilities for graduation-stage companies, financially supporting emerging businesses and attracting large employers to the area.
Suddenly one obesity asset has come to define Amgen but executives see a fuller portfolio that will bring the big biotech into the future.