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After a chaotic year that has seen the attrition of over half the FDA’s senior leadership, many of these individuals have landed new roles—at Eli Lilly, Pfizer, Iovance and more. The FDA’s loss, it seems, is largely the pharmaceutical industry’s gain.
Despite announcing a broad pivot to siRNA earlier this year, Sarepta is following through with an investigational gene therapy: its limb-girdle muscular dystrophy candidate. But the treatment’s path forward, analysts say, is highly uncertain.
Sheila Gujrathi, former CEO of Gossamer Bio, has written a new book that aims to offer the type of leadership manual she never had in her early career.
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Pfizer Inc. announced the election of Cyrus Taraporevala to its Board of Directors, effective immediately.
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Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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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.
The court’s decision allows Metsera to walk away from its previous acquisition agreement with Pfizer in favor of Novo Nordisk’s higher bid.
Pressure from the FTC and Pfizer is building around Novo Nordisk’s bid to snatch obesity biotech Metsera. The antitrust watchdog has spotted issues with the structure of Novo’s bid, while its New York-based rival has put more money on the table.