US, EU agree to terms of framework trade pact
The two trading partners documented provisions of a deal that would set a 15% tariff on many EU imports, including cars, auto parts, pharmaceuticals and semiconductors.
More than 1,100 devices have received the FDA’s breakthrough designation
The FDA updated its list of breakthrough devices as medtech groups lobby for faster Medicare coverage of products with the designation.
More than 1,100 devices have received the FDA’s breakthrough designation Read More »
Option Care Health taps new CFO
Meenal Sethna will join the infusion therapy provider in October. She’ll succeed former CFO Michael Shapiro, who will continue to work in a transition role through March.
White House data sharing plan boasts big ambitions, but has scant details
Improving health data exchange is a worthy goal, but the initiative so far includes few details on how it will work — and has plenty of barriers to overcome, experts say.
White House data sharing plan boasts big ambitions, but has scant details Read More »
J&J Adds $2B to US Manufacturing Commitment Amid Trump’s Protracted Tariff Threats
President Donald Trump first threatened pharma tariffs in February and recently said they were imminent. Johnson & Johnson’s new investment adds to a $55 billion pledge made by the company in March.
J&J Adds $2B to US Manufacturing Commitment Amid Trump’s Protracted Tariff Threats Read More »
Stealth’s Flight Path Returns to FDA for Rejected Barth Drug
Stealth BioTherapeutics originally submitted elamipretide for approval in January 2024, only to receive a rejection in May of this year. In addition to accepting the biotech’s resubmission, the FDA has promised to take action on the candidate by Sept. 26.
Stealth’s Flight Path Returns to FDA for Rejected Barth Drug Read More »
Why AI Won’t Save the 90% of Clinical Trials That Still Fail
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses clinical trial fail rates and AI’s potential to reduce preclinical costs with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
Why AI Won’t Save the 90% of Clinical Trials That Still Fail Read More »
Washington’s Life Sciences Scene Moves Beyond Research Roots
Washington has had notable life sciences job growth over the past 10 years, according to a Life Science Washington report. The association’s CEO and a biopharma CEO discuss what makes the state stand out, including its talent pool, AI leadership and entrepreneurship support.
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Two FDA Decisions for Regeneron’s Eylea HD Delayed Into Q4
The delays, first revealed in Regeron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.
Two FDA Decisions for Regeneron’s Eylea HD Delayed Into Q4 Read More »
Hundreds of HHS Staffers Accuse RFK Jr. of ‘Sowing Public Mistrust’ Against CDC After Shooting at HQ
In an open letter, Health and Human Services employees asked the Secretary to stop and disavow the spread of health misinformation, particularly about vaccines, infectious diseases and federal health agencies.