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Backed by institutional investors and seasoned industry leaders, cAMPfield Therapeutics is advancing a clinical program aimed at reshaping the landscape for inflammatory bowel disease.
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Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
After suffering the market withdrawal of its only product, Amylyx is gearing up for a pivotal Phase 3 readout in post-bariatric hypoglycemia. But the company’s driving ethos is still to treat “debilitating, devastating” neurodegenerative diseases, co-CEO Justin Klee told BioSpace.
Biotechs are benefitting from the AI tech frenzy and inflation, but validated pipelines and careful planning are still key to the recent record-setting IPOs, experts say.
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Moderna appears to have aligned with the FDA ahead of an advisory committee meeting for its mRNA-based flu vaccine, which the regulator initially turned away in February; biotech IPOs are going gangbusters, including two new records raises in as many weeks; layoffs continue across biopharma; plus much more.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Neumora Therapeutics is laying off 35% of workers after its most advanced asset failed a pair of Phase 3 studies, sending the biotech’s stock spiraling early Monday.
Weeks after Boehringer Ingelheim and Eli Lilly retracted billions of dollar in German commitments, the nation’s government is reportedly changing a contentious element of its planned healthcare reforms.
Intellia Therapeutics’s Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.
Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.
After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.
Novo Nordisk said that the information affected by the breach shouldn’t allow third parties to “identify participants in our clinical trials” despite “unauthorized access” to patients’ personal data.
The staffing changes will focus resources on work that creates the highest impact for patients, according to Genentech. The number of employees affected is unknown, but longtime veteran Vishva Dixit is out.
Instead of using viral vectors, SonoThera’s genetic medicines are delivered through an ultrasound-mediated technology that could help sidestep key safety issues with conventional delivery methods.