Trump’s executive order on drug pricing; Pfizer drops oral obesity drug; Seed...
Happy Saturday and welcome back to Endpoints Weekly. It was a short week for us with Good Friday this week, but we’re still chock full of news to recap for you. It was another busy ...
View ArticleFDA approves Dupixent for hives, rejects new Eylea dosing schedule
The FDA made two decisions on Regeneron’s best-selling drugs Friday, handing down one approval and one rejection. The approval came for Dupixent, the megablockbuster Regeneron develops and sells with...
View ArticleRoivant brings rare disease program closer as Immunovant CEO retires
Roivant is changing its strategy for Immunovant roughly a month after its subsidiary decided it wouldn’t take one of its drugs to the FDA despite a Phase 3 win. The biopharma company will move to ...
View ArticleTrodelvy and Keytruda combo succeeds in Phase 3 breast cancer study
Gilead's antibody-drug conjugate Trodelvy combined with Merck's Keytruda reduced the risk of disease progression or death in a key study of an aggressive form of breast cancer. Gilead announced Monday...
View ArticleChina biotech startup HuidaGene uses CRISPR in brain for rare ailment
Late last year, doctors injected an experimental CRISPR therapy into the brain of a 9-year-old boy with a rare neurodevelopmental condition that can cause intellectual disability, movement problems and...
View ArticleAlvogen unit appeals court loss in bid to market Xifaxan generic
Alvogen plans to fight a court decision that could significantly delay its ability to bring a generic version of Bausch Health's Xifaxan to market, the company said. On Friday, its subsidiary Norwich...
View ArticleFDA's Makary floats new approval pathway for rare disease drugs
It's been a little more than two weeks since Marty Makary took over as FDA commissioner and already he's announcing plans for a new, customized conditional drug approval pathway for therapies that...
View ArticleFDA to ban pharma employees from serving on adcomms
The FDA is looking to further limit pharma companies' involvement in advisory committees that typically review new drugs or safety issues. But the shift away from pharma influence is likely to have...
View ArticleAstraZeneca, Daiichi eye first-line breast cancer market after Enhertu's...
AstraZeneca and Daiichi Sankyo’s Enhertu cut the risk of progression or death compared with the standard of care for first-line HER2-positive metastatic breast cancer, the companies said Monday. The...
View ArticleUpdated: Roche’s $50B US investment includes previous build announcements
Roche is the latest pharma giant to earmark billions of dollars to boost its R&D and manufacturing presence in the US, with an estimate of $50 billion worth of investment over five years. Yet a ...
View ArticleAs the XBI suffers, Q1 shows a few comforting signs of underlying stability
The XBI has plunged 27% since Donald Trump won the election, leaving the public markets an ugly mess for a biotech industry yearning for better times. Talk to CEOs these days and the mood for ...
View ArticlePreventive health startup Superpower raises $30M
Superpower, a startup that aims to help consumers have more information about their health, raised $30 million. The San Francisco-based company joins a growing group of longevity-focused startups like...
View ArticleDrugmakers stockpile inventory in the US, seeking to get ahead of Trump tariffs
Large pharmaceutical companies that make drugs around the world have begun to ship and stockpile products inside US borders, in an effort to blunt the impact of the Trump administration’s expected...
View ArticleGeorge Church startup Matter Bio will study long-lived animals, humans
The animal kingdom is full of creatures that live longer than expected. Naked mole rats survive three or four decades. Some parrots survive upwards of 60 years, outliving their owners when kept as...
View ArticleDanaher expects about $350M in tariff costs; Alumis, Acelyrin adjust deal terms
Plus, news about Invivyd: Danaher’s tariffs hit: The life sciences company currently expects the costs of tariffs to be “something like $350 million” in 2025, according to CEO Rainer Blair on Tuesday’s...
View ArticleInsurers have a Medicare Advantage problem
How much longer will Medicare Advantage continue to beat up health insurance earnings? For two years now, we’ve been chronicling how higher costs among seniors enrolled in Medicare Advantage (the...
View ArticleGalapagos CEO Paul Stoffels to step down, former Neumora chief to lead spinout
Paul Stoffels joined Galapagos to turn it around three years ago. But after a series of unsuccessful studies, pipeline changes and a bumpy quest into cell therapy, the Belgian biotech's turnaround...
View ArticleRegeneron to boost its US manufacturing through a $3B Fujifilm deal
Fujifilm Diosynth Biotechnologies' bet on its North Carolina biologics facility is paying off, as Regeneron plans to shell out several billion dollars to move manufacturing to the site. Over the next...
View ArticleRecent FDA staff cuts to delay drug hearing decision by months, agency tells...
For the first time since the Trump administration's major staff cuts at the FDA this month, the agency publicly announced that the firings will lead to a long delay for what would otherwise be a ...
View ArticleAstraZeneca rejoins PhRMA, two years after leaving lobby group
British drugmaker AstraZeneca is rejoining the drug industry's major US lobbying group, PhRMA, roughly two years after quitting the organization. As part of its membership, AstraZeneca CEO Pascal...
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