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The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.
FEATURED STORIES
The industry’s ability to generate a return on billions of dollars of investment rests on a heavily regulated supply chain defined by time-pressured logistics.
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Job Trends
The biopharma job market likely won’t turn around until 2026, according to two industry experts. Both cited a need for more investment and noted the impact of uncertainty on the industry.
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As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and pharma executives—and the general comradery in the air throughout the chaotic event.
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After GSK subsidiary Tesaro filed a lawsuit Thursday claiming that AnaptysBio breached “certain requirements” under their 2014 license agreement involving GSK’s Jemperli, Anaptys responded Friday morning.
Amid an aggressive savings push, Moderna has cut three assets and taken on a loan to increase “flexibility.”
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.