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The two most historically deal-conservative Big Pharmas have the most money to play with for a major M&A transaction, according to a recent Stifel analysis.
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Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program.
From Wall Street to real estate to a “big, ugly” pharma building, Mayo Venture Partner Audrey Greenberg reflects on a career defined by taking a leap at just the right moment.
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One year since forming its Advisory Board, Lokavant, the clinical trial intelligence platform company, announces three new members, including Pfizer’s Head of Predictive Analytics Jonathan Crowther.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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As more and more groups call for the health secretary’s removal from office, senators will question Kennedy on his recent moves, including the controversial firing of CDC Director Susan Monarez.
In this episode presented by Taconic Biosciences, BioSpace’s head of insights Lori Ellis discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment with Mike Garrett, CEO.
The reprioritization effort will help AC Immune extend its cash runway through the third quarter of 2027.
While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and advocates question what tangible impacts the new guidelines will have.
YouTube has shut down a channel containing hundreds of videos of comments made by doctors and other influencers—including CBER Director Vinay Prasad, Health Secretary Robert F. Kennedy Jr. and NIH Director Jay Bhattacharya—during the pandemic. This comes as Prasad reveals further details about last week’s updated COVID-19 approvals.
Wave’s RNA editor resulted in protein levels that were “exceedingly close” to what investors were expecting, but nevertheless fell short of that bar, according to analysts at Truist Securities.
As AAV9 and CRISPR programs navigate safety, delivery and scalability hurdles, small molecules offer a deployable, scalable bridge, complementing genetic approaches and accelerating meaningful impact for patients with Duchenne muscular dystrophy.
Albert Bourla heralded the president’s COVID-19 leadership and Operation Warp Speed initiative as a Nobel Prize–worthy achievement and said that Pfizer stands by the integrity of the data already shared.
In a series of memos last week, Center for Biologics Evaluation and Research Director Vinay Prasad outlined the FDA’s thinking on the recent limited approvals for updated COVID-19 vaccines.
In an opinion piece in the Wall Street Journal, Health Secretary Robert F. Kennedy Jr. said he will roll chronic disease programs into a new Administration for a Healthy America.