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A lower court had previously ruled for Sarepta in the companies’ long-running dispute, finding that REGENXBIO’s AAV patent was invalid because its elements were naturally occurring. The appeals court on Friday said that this original decision adopts a “narrow” view of the invention.
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Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
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Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Eli Lilly’s idiopathic pulmonary fibrosis deal with Mediar is centered around MTX-463, an anti-WISP1 antibody that early studies have found to be safe and capable of engaging its target.
On Thursday, Boehringer Ingelheim announced a partnership with Synaffix to advance antibody-drug conjugates and exercised its fourth license option under a 2013 collaboration with Oxford BioTherapeutics.
Ouro is planning to leverage T cell engagers to deplete B cells and “reset” the immune system to treat immune-mediated diseases.
Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the latest setbacks for the controversial platform trial, the results from which have largely mirrored the dismal success rate in ALS overall.
Initial rounds of VC financing totaled $7.7 billion over 137 deals for biopharma in 2024, compared to $3.8 billion over 156 deals in 2023.
MaaT013 in 2022 was put under clinical hold by the FDA, which cited safety and efficacy concerns with the sample-pooling method used to produce the investigational therapy. The hold was lifted in April 2023.
The company’s lead asset is a potentially first-in-class oral GLP-1 receptor agonist that has the potential to be dosed weekly, which according to CEO Khurem Farooq can help improve accessibility and affordability.
Vanda called the attention of FDA Commissioner Robert Califf to what it termed the “sentiment that the agency avoids public scrutiny of its decisions.”
According to BMO Capital Markets, Medicare coverage of Lilly’s Zepbound opens the door to using secondary indications to secure CMS coverage for obesity drugs.
Being laid off is bad enough. When companies mishandle the layoff process, it can make the situation even worse. Four biopharma professionals share how some employers are getting it wrong.