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FDA
Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
Sanofi and Regeneron have had a long and “sometimes contentious” partnership, BMO Capital Markets noted, as the companies contend with the looming loss of exclusivity of their blockbuster drug Dupixent.
After a frantic second quarter, M&A steadied with just under $30 billion across 22 total transactions, according to a BioSpace analysis.
In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.
Based on typical fourth quarter hiring activity, biopharma job seekers should apply for open roles sooner than later. Recruiting and career coaching experts offer advice on timing, networking, interviewing and casting a wider net than usual during Q4.
UPCOMING EVENTS
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
FDA
Ebvallo, which Pierre Fabre Pharmaceuticals and Atara Biotherapeutics are proposing to treat a posttransplant complication, joins a wave of rejected or discouraged therapies on which the FDA has reversed previous guidance after the exit of former Commissioner Marty Makary.
Of the 38 companies receiving incentives, 31 will expand outside of Boston and Cambridge. Still, Boston and Cambridge are each expected to gain over 200 jobs. Tax incentive award recipients include AstraZeneca, Bristol Myers Squibb and Insulet.
EloraTZP—a combination of an amylin asset and Eli Lilly’s approved obesity drug Zepbound—made a clean sweep of the primary and secondary endpoints in a mid-stage trial of adults with obesity and type 2 diabetes, setting up the launch of a Phase 3 trial before the end of the year.
Eli Lilly’s weight loss pill Foundayo has had a “slower-than-hoped” launch, according to BMO Capital Markets, which contended that the indirect comparison data—despite falling short of definitive proof of superiority—could help the Indiana giant build momentum for its oral drug.
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