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After decades of limited progress—owing to the difficulty of treating the disease and resultant market risk—glioblastoma research is entering a new phase spurred by smarter trials, targeted funding and renewed interest from companies like Merck and Jazz Pharmaceuticals.
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Drug pricing, budget cuts, tariffs and other shifts under the Trump administration undermine the biopharma and healthcare ecosystem.
The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.
In advance of this week’s CDC vaccine advisory meeting, HHS Secretary Robert F. Kennedy Jr. restacked the committee, claiming problematic industry ties within the previous group. Experts say ACIP had long navigated COIs appropriately and that the new appointees risk the apolitical nature of membership.
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Acquisition includes two pre-clinical bispecific antibodies targeting proven disease pathways, offering the potential to transform the treatment paradigm for patients living with atopic dermatitis and other immune-mediated diseases.
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Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
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.
BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.
The acquisition, which will give Sanofi a combination vaccine for respiratory syncytial virus and human metapneumovirus, follows the pharma’s potential $1.4 billion COVID vaccine licensing deal with Novavax last year, plus a number of other big-ticket commitments outside of the vaccine space.
The money will focus on a manufacturing plant in Virginia that will make the company’s weight management and metabolic drugs like the hypertension drug baxdrostat and oral GLP-1 therapies.
In May, biotech iTeos Therapeutics decided to close down after being abandoned by GSK over the disappointing mid-stage performance of its anti-TIGIT antibody belrestotug.
In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis continues the discussion on mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines and Pad Chivukula of Arcturus Therapeutics.
After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.