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Senator Bill Cassidy voted with fellow Republicans on the Senate Finance Committee Tuesday morning to move forward the nomination of Robert F. Kennedy, Jr. for HHS secretary.
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Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
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Alto Neuroscience today announced that founder and chief executive officer, Amit Etkin, M.D., Ph.D., will present at the Oppenheimer 33rd Annual Healthcare Conference taking place virtually.
FROM OUR EDITORS
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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Tuesday’s round brings Bain Capital Life Sciences’ fundraising total to around $6.7 billion since its founding in 2016. Many of its portfolio companies have resulted in high-value exits recently, including Cerevel Therapeutics, Aiolos Bio and Jnana Therapeutics.
Plus, learn about what to expect in initial interviews and how to time your post-Ph.D. job search for maximum success.
BioMarin’s new business strategy leaves investors with questions; Lykos CEO steps down; Terns releases compelling data on oral weight loss candidate; and more.
Phase I data for TERN-601 suggests Terns’ oral GLP-1 candidate for obesity could be a contender in the market next to big names like Lilly, Pfizer and Roche.
Under an in-license agreement worth up to $294 million, Roivant Sciences gains exclusive worldwide rights from Bayer to develop and commercialize mosliciguat, a potential first-in-class inhaled soluble guanylate cyclase activator.
The U.S. House of Representatives on Monday overwhelmingly passed the bipartisan bill, which targets WuXi AppTec, WuXi Biologics and other Chinese biotech companies as potential national security risks.
Despite the disappointing late-stage results in non-small cell lung cancer, Jefferies analyst Stephen Barker contends the likelihood of FDA approval “remains high” for the experimental antibody-drug conjugate, though the regulator is now more likely to convene an advisory committee.
Candid Therapeutics, which is repositioning two antibodies for autoimmune indications, will be led by Ken Song who was previously CEO of RayzeBio and oversaw its $4.1 billion acquisition by Bristol Myers Squibb.
Terns Pharmaceuticals will advance TERN-601 into Phase II after early-stage data showed the oral therapy led to weight loss of 4.9%, comparable with weight loss pills Lilly and Pfizer are developing, according to analysts.
Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer.