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Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own investigational obesity asset MariTide, which could open up monthly or more infrequent dosing schedules.
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We must treat drug resistance as a central scientific priority rather than an unavoidable complication.
Altitude Labs, an offshoot of AI-focused techbio Recursion, is teaching scientists to build companies, one founder at a time.
With six acquisitions already this year, Eli Lilly’s business development shows no signs of stopping as executives make good on a promise to spend their GLP-1 gains.
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After striking a Most Favored Nation deal with the White House in January, Johnson & Johnson will now offer Xarelto at 68% off on TrumpRx, dropping its price from $611.82 to $197 per 30-pill pack.
As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
Daiichi Sankyo’s full-year report was originally scheduled for April 27 but has now been pushed back to May 11. That same day, the pharma expects to release its five-year business plan.
Pfizer’s decision to cut its early-stage cancer asset was due to “strategic business reasons” and not driven by safety or efficacy concerns.
Of the 17 companies that were implored by the White House last July to apply Most Favored Nation pricing to their drugs, Regeneron is the last to agree—the same day the FDA greenlit its gene therapy for hearing loss in kids.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.