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Right after reporting a major Phase 3 LAG-3 miss that has rattled analysts, Regeneron Pharmaceuticals revealed a back-loaded partnership with Parabilis Medicines aimed at adding a new drug class to its early-stage pipeline.
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The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
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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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After a cacophony of troubles hit the RNA editing biotech last fall, CEO Ram Aiyar is in San Francisco to develop partnerships, pitch the potential of its new AATD program and find more money to keep the dream alive.
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
Strive Compounding Pharmacy alleged in its lawsuit that Eli Lilly and Novo Nordisk have worked to lock telehealth providers in exclusive partnerships, disallowing them from offering compounded versions of GLP-1 medicines.
Half of the net proceeds will go to Jazz; it remains unclear who will get the remaining sum. Jazz did not reveal the buyer of the voucher.
2026 is shaping up to be a pivotal year for rare disease drugmakers, with key approvals, filings and readouts lined up for this year.
It doesn’t matter how many times you have traversed Union Square; no one knows which way is north, or where The Westin is in relation to the Ritz Carlton. A Verizon outage brought that into focus on Wednesday of JPM week.
Venture funds attending the J.P. Morgan Healthcare Conference said mounting funding pressures and Chinese competition have sharpened their focus on leadership qualities, from regulatory expertise and industry experience to the ability to scale—or step aside—as companies mature.
Looking for a manufacturing job? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
The past year saw manufacturing challenges pushed into the spotlight. BioSpace spoke to two executives who shared key issues facing those working in this area, from finding the right providers to dealing with regulatory uncertainty.