Winning the race to market with the first oral selective estrogen receptor degrader (SERD) for breast cancer is Menarini Group’s elacestrant, which gained U.S. FDA approval for use as second- and third-line therapy in patients with ER-positive/HER2-negative advanced or metastatic disease with the ESR1 mutation. It marks the first therapy approved specifically targeting ESR1, found in up to 40% of patients with ER-positive/HER2-negative disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Argenx, Astrazeneca, Bioaegis, Bloomsbury, Bristol Myers Squibb, Eisai, Eli Lilly, Exegi, Ipsen, Merck, Orion, Regeneron, Sana, Sanofi, Viatris.
Makers of medical devices and pharmaceuticals face a significant risk of product liability litigation, but the use of third-party funding of such lawsuits is a novelty in the U.S. relative to some other Western nations. Nonetheless, a new report by the U.S. Government Accountability Office (GAO) makes clear that third-party litigation funding is an increasing common practice that seeks to include uninjured parties in mass tort litigation, thus endangering the fortunes of those who invest in life science companies.
Four members of the U.S. Senate have inked a draft bill that would require the FDA and the Patent and Trademark Office (PTO) to set up a task force designed to improve communication between the two agencies. This would appear to replicate a bill introduced during the 117th Congress, but not ultimately passed, and there is little clarity this early in the legislative cycle as to the prospects for this latest iteration.
Real-world evidence (RWE) is all the rage in med-tech circles, given the promised efficiencies, but the U.K. National Institute for Health and Care Excellence is especially dialed in on RWE. The agency recently announced that it will expand its use of RWE to include health technology assessments (HTAs), promising a slightly less drag-filled path to clinical adoption in one of the world’s most robust markets.
Mantle cell lymphoma (MCL) patients developing resistance to existing BTK inhibitors now have a new treatment option, with the U.S. FDA’s accelerated approval of Jaypirca (pirtobrutinib) from Eli Lilly and Co.’s oncology unit, Loxo@Lilly. It is indicated for use in adults with relapsed or refractory disease who have received at least two lines of systemic therapy, including a BTK inhibitor.
Where European regulatory decisions were concerned, there was good news and bad news for pharma today as Sanofi SA and Regeneron Pharmaceuticals Inc. got the go-ahead for expanded approval of Dupixent (dupilumab) in pediatric atopic dermatitis patients whilst Ipsen SA’s ultra-rare bone disease drug palovarotene was left off the shelf as efficacy data failed to impress.
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Infinity Neuro.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Centessa, Daewoong, Daiichi, Discgenics, Lapix, Syros, Valeo.
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