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The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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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.
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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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A new analysis from Jefferies shows that drugs receiving breakthrough designations sail through the regulatory process more quickly, on top of frequently winning approval.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
Aspen is now also considering the possibility of an initial public offering next year in an effort to bring its cell therapy to the market.
The nod brings Bayer face-to-face in the market with Boehringer Ingelheim and AstraZeneca, each of which has its own HER2 blocker for non-small cell lung cancer.
The approvals come as a pleasant surprise for Regeneron, analysts say, helping bolster the overall product profile of high-dose Eylea despite outstanding manufacturing concerns.
Biopharma professionals will probably find decreasing employment opportunities this month and next even as layoffs continue, based on BioSpace data. However, hundreds of open roles are expected this year in Massachusetts, and a job market turnaround could start late next year.
If Eli Lilly’s obesity pill orforglipron is approved and priced around $200 per month, analysts at Truist predict patients will flock to it.
The CRO market in the APAC region is thriving, particularly in China, due to intense clinical trial and innovation development, with Western investors and pharma leaning in.
A spokesperson for the FDA said the agency is “considering a wide range of options to support American innovation.”
Lundbeck had tried to scoop the narcolepsy drug maker out from under Alkeremes with $2.4 billion, but Avadel has elected to go with its original suitor.