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While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.
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As cell and gene therapy leaders gathered in Maryland to discuss accelerating clinical trials in children, one “cutting edge” session focused on the need to expedite more bespoke gene editing treatments like the one that saved young KJ Muldoon.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z.
Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease.
The nausea and other gastrointestinal side effects of weight loss drugs like Novo Nordisk’s Wegovy or Eli Lilly’s Zepbound will limit how much these drugs can help patients and stunt the overall obesity market unless we approach the problem head on.
The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, with the exception of Eli Lilly’s orforglipron, the vouchers are for drugs that are already on the market.
The agreement will also secure a $150 price for future weight loss pills from Novo Nordisk and Eli Lilly—at least initially.
The company reported $200 million in net losses for the third quarter, but an aggressive and highly successful cost-cutting campaign is helping to stem the downward trend.
The highest dose of Eli Lilly’s eloralintide led to 20.1% weight loss after 48 weeks in a Phase II trial, exceeding analyst expectations and highlighting a “potentially best in class profile,” according to BMO Capital Markets.
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
In an investor call Thursday, AstraZeneca CEO Pascal Soriot outlined his company’s approach to obesity drug development based on “the medical aspect” of weight loss, including driving down visceral fat.
The search continues for a new leader for the FDA’s Center for Drug Evaluation and Research after George Tidmarsh resigned on Sunday. Deputy Director Mike Davis is in the running, along with Mary Thanh Hai, currently head of the Office of New Drugs.