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While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and advocates question what tangible impacts the new guidelines will have.
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ADARx Pharmaceuticals CEO Zhen Li found her way to biopharma through Merck, where she was inspired by the application of powerful science to human medicine.
When talking to some of the most impressive women in biopharma, the conversation inevitably turned to what these women wanted other entrepreneurs to know. Here’s the best of the best of that advice.
Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the regulator considers more drastic action.
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Amgen will present at Jefferies Global Healthcare Conference at 9:00 a.m. ET on Thursday, June 6, 2024.
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After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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Waltham, Massachusetts–based Skyhawk Therapeutics has been collecting collaborations with larger companies in spades since launching in 2018.
Patients who are prescribed Wegovy or Ozempic can now use GoodRx to access the medications at just $499 a month if they skip insurance. This is not the first time Novo has partnered with a pharmacy to offer the blockbuster drugs.
Inclacumab, which Pfizer obtained in its 2022 acquisition of Global Blood Therapeutics, failed to significantly lower pain episodes in patients with sickle cell disease over the 48-week treatment period.
Kriya is advancing a host of gene therapies for a wide variety of chronic diseases, including geographic atrophy, trigeminal neuralgia and type 1 diabetes.
In Phase III studies, Tonmya showed significantly superior analgesic effects in patients with fibromyalgia versus placebo. The sublingual pill also led to better clinical outcomes.
The label expansion could help Novo Nordisk “help shift the momentum” for Wegovy, after a difficult start to 2025, according to analysts at BMO Capital Markets.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
Papzimeos is the first immunotherapy approved for recurrent respiratory papillomatosis, a rare lung disorder involving the development of benign tumors in the airways.
The move comes after Robert F. Kennedy Jr. received pressure from the Children’s Health Defense, an anti-vaccine non-profit that he co-founded, which last month sued him over his failure to run the “statutorily required Task Force on childhood vaccine,” according to the lawsuit.
The Department of Health and Human Services’ mRNA pullback only applies to their use in upper respiratory disease, according to Secretary Robert F. Kennedy Jr.