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While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”
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Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.
The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.
Revenue for 2023 is now expected to decline to the low single digits instead of the 2% growth projected. Leadership pointed to the company’s multiple myeloma drugs as the main drags on earnings.
Amid the impending drug pricing pressures from the Inflation Reduction Act, Roche is discontinuing a mid-stage hemophilia A gene therapy candidate and four early-stage hopefuls.
Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.
The company reported second-quarter revenue Wednesday that included $248.4 million of back royalties and associated interest related to the successful outcome of an arbitration case with J&J’s Janssen.
With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.
On the heels of a European Union investigation, the UK’s health agency is reviewing safety data for GLP-1 receptor agonists after reports of self-harm and suicidal thoughts.
In a recent study of the U.S. states with the best and worst job markets, nine came out on top. Read on for details about the life sciences industry and jobs available in each state.
The Phase III trial, which will test the companies’ mRNA-based personalized cancer vaccine and Merck’s blockbuster Keytruda checkpoint inhibitor, is slated for completion by the fall of 2029.