BioNTech doesn't see ‘near-term’ impact from RFK Jr.'s vaccine policy proposal
A proposal by HHS Secretary Robert F. Kennedy Jr. to change the approval standard of new vaccines shouldn't affect BioNTech's Covid-19 franchise, the company told investors Monday. Biotech and pharma...
View ArticleBristol Myers to lay off over 500 workers in New Jersey
Bristol Myers Squibb is letting go of 516 workers in New Jersey as part of a wide-reaching cost-cutting plan aimed at making the drugmaker more efficient. The company, based in Princeton, NJ, first...
View ArticlePTC's Huntington’s study succeeds, but accelerated approval uncertain
PTC Therapeutics announced Monday that its splicing drug for Huntington’s disease met the primary endpoint of a Phase 2 study, but stopped short of spelling out the important data that could ...
View ArticleFDA adcomm to review Capricor's Duchenne cell therapy
Capricor Therapeutics' cell therapy for Duchenne muscular dystrophy will face an FDA advisory committee ahead of an approval decision that's expected Aug. 31, the company disclosed on Monday. The San...
View ArticleNew opioid data may not be generalizable, FDA adcomm says
Several members of an FDA advisory committee warned on Monday that new data from studies on long-term use of opioids might underestimate the harms from their misuse and abuse. The committee reviewed...
View ArticleVertex touts promising launch for non-opioid pain drug Journavx
Vertex said it's gathering momentum with its new product launches, building out new franchises with its sickle cell therapy Casgevy, another cystic fibrosis drug in Alyftrek, and the non-opioid pain...
View ArticleSingapore cardio gene therapy biotech collects $45M as it plots Europe expansion
A Singapore-based startup raised a $45 million Series B to start testing a gene therapy in humans next year for a genetic heart muscle disorder, signaling that the AAV-based gene therapy field still...
View ArticleAldeyra plots third FDA filing for dry eye disease drug after latest Phase 3...
Aldeyra Therapeutics isn’t giving up on its drug candidate for dry eye disease despite a challenging path so far. The company is preparing to file reproxalap with the FDA for the third time after a ...
View ArticleDegradation startup raises $39M for pivot to PROTACs and clinical entry
PAQ Therapeutics has taken a new direction. The startup shifted its protein degradation approach to the more common PROTAC lane, pivoted to cancer, hired a chief medical officer from Frontier...
View ArticleLilly to pay up to $415M in ALS deal; Actuate’s mid-stage pancreatic cancer data
Plus, news about Atara Biotherapeutics, Immutep, bluebird bio, OSE Immunotherapeutics, Mersana Therapeutics, Innovent, Biomea Fusion and Trailhead Biosystems: Eli Lilly does another ALS deal: The...
View ArticleVertex pauses study of mRNA therapy for cystic fibrosis
Vertex paused an early-stage trial of its inhaled treatment for cystic fibrosis that came from a partnership with Moderna. The biotech said Monday in its first-quarter press release that it's...
View ArticleAnti-aging biotech NewLimit raises $130M Series B round
NewLimit, an anti-aging biotech startup backed by Coinbase CEO Brian Armstrong, has raised a $130 million Series B round to get its lead drug candidates closer to human testing. The South San...
View ArticleControversial doctor Vinay Prasad named CBER director at FDA
FDA Commissioner Marty Makary named Vinay Prasad as the next director of the Center for Biologics Evaluation and Research, putting a strident critic of the agency in charge of one of its most important...
View ArticleEurope pledges €500M to attract global science talent
The European Union is committing €500 million ($556 million) over the next two years to make Europe a “magnet” for researchers from around the world. The funding was announced Monday by European...
View ArticleTrump, FDA zero in on foreign factories to give domestic sites an edge
With several large pharma companies promising billions of dollars to reshore manufacturing to the US, President Donald Trump and the FDA have started on plans that would give current and future...
View ArticlePlans to match US drug prices to those overseas gain steam in Washington
House and Senate lawmakers from both parties are working with the Trump administration on proposals that would use drug prices paid by other developed countries as a reference for the US, an idea that...
View ArticleSEC expected to drop investigation of Illumina's $8B Grail deal
The SEC is expected to drop an investigation into Illumina's $8 billion acquisition of cancer test developer Grail, Endpoints News has learned. In 2023, Illumina disclosed in a regulatory filing that...
View ArticleStates sue US over plan for reorganization of federal health agencies
Attorneys general from 19 states and Washington, DC have filed a lawsuit against the federal government alleging that its plan for a broad restructuring of health agencies is “an unlawful effort to...
View ArticleSarepta’s stock plummets after Prasad appointment, low Elevidys sales
Sarepta Therapeutics had a bad day in Washington. And then a worse one on Wall Street. On Tuesday, the company's stock fell 27% following the news that Vinay Prasad would be the new head of ...
View ArticleMarea heads to Phase 2b after updated biomarker data show CV drug’s promise
Marea Therapeutics said on Wednesday that its lipid-lowering antibody cut both remnant cholesterol levels and remnant triglycerides — both indicators for cardiovascular disease in at-risk patients. The...
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