Drug tool and packaging makers to feel brunt of Trump tariffs, analysts say
Pharma tool and packaging production companies are readying themselves for direct impact from President Donald Trump’s tariffs, which could then have a knock-on effect on their biopharma and CDMO...
View Article‘This is self-inflicted’: Leerink’s David Risinger on the market shock and...
As the markets continued to fall Monday in response to the Trump administration’s tariff proposals, biotech has particularly been hit hard. The industry was already being hammered by firings at the FDA...
View ArticleRare disease hub at CDER and CBER faces new reality with staff crunch
Amy Comstock Rick joined the FDA last November, and she not only survived the widespread staff cuts last week, she's one of only a handful of FDA officials to speak at a live conference since ...
View ArticlePureTech rejects cash exit proposal from Nordic Capital after deal talks
PureTech Health, a Boston biopharma company that has created drug developers like Karuna Therapeutics and Seaport Therapeutics, confirmed on Monday that it was in discussions with Nordic Capital...
View ArticleFederal judge in Minnesota dismisses drugmakers' 340B lawsuits
A federal judge in Minnesota knocked down challenges from two drugmakers against a state law that the companies argued overly expanded the scope of the government's 340B drug discount program. Judge...
View ArticleHHS says it may revisit policy for anti-obesity drugs
The government said it “may consider future policy options” for anti-obesity medications, after declining to finalize a Biden-era proposal that would have expanded coverage to millions of Medicare...
View ArticleTrump administration hikes Medicare Advantage payments by $25B
The Trump administration will hike payments to Medicare Advantage insurers by more than $25 billion next year, according to an annual rate announcement released Monday afternoon. CMS said payments to...
View ArticleUS commission calls for $15B biotech investment to blunt China
A congressional commission is advocating for a $15 billion federal investment in America’s biotechnology sector, warning that the US could soon be eclipsed by China in a key frontier of innovation. In...
View ArticleExclusive: Merida Biosciences gets $121M to treat autoimmune and allergy...
A scrappy team of drug developers has come together to create new medicines for patients with autoimmune diseases and allergies. They're going after the bustling subfield of Graves' disease and also...
View ArticleCartesian reveals long-term mid-stage data for cell therapy in myasthenia gravis
Cartesian Therapeutics said its autologous CAR-T therapy has shown “sustained benefits” in people with a rare autoimmune disease, according to the latest data cut from a Phase 2b trial. Four out of 12...
View ArticleQ&A: Lundbeck’s head of R&D on letting ‘biology speak’ in neuroscience
Johan Luthman has been running R&D at Lundbeck since 2019, and part of the neuroscience leader’s remit is helping steer development of a promising but still-experimental seizure medication that the...
View ArticleRallybio ends development in rare disorder; ImmunityBio raises $75M
Plus, news about KalVista, Kaken Pharmaceutical, Lyell and Tango Therapeutics: Rallybio stops work on RLYB212: The company had been testing the drug to see if it could prevent fetal and neonatal...
View ArticleNovo Nordisk, HHS clash in court over IRA drug selection
Novo Nordisk focused on a unique argument in federal appeals court on Tuesday in a case that will consider the extent to which the judiciary can review which drugs HHS says are eligible for Medicare ...
View ArticleKennedy's FDA cuts raise questions about 'trigger' for user fees
Last week's thousands of FDA job cuts will take a major chunk out of what the agency spends each year as part of its nearly $7 billion budget. But they could — theoretically — also have other ...
View ArticleWhat stock market chaos means for health tech
The markets have been volatile over the past few days, turned upside down by the tariffs announced by President Donald Trump. No industry has been spared. Our corner of health ...
View ArticleNIH appeals nationwide block on indirect cost cuts
The Trump administration on Tuesday said it will challenge a federal judge’s order that blocks its planned 15% rate limit on indirect cost reimbursements for NIH grant recipients nationwide. The...
View ArticleHouse panel mulls ways to boost struggling biosimilar market
The state of the US biosimilar market isn't as healthy as it should be despite significant advances in the past decade, health policy experts told a House panel on Tuesday. The US still struggles to ...
View ArticlePharma CEOs warn EU of potential US exodus as trade war continues
Executives of major pharmaceutical companies warned the European Union that they’re likely to take the US’ side amid the threat of new tariffs. The European Federation of Pharmaceutical Industries and...
View ArticlePharma is next in line as Trump says tariffs are coming 'very shortly'
President Donald Trump warned Tuesday evening that “major” pharmaceutical tariffs will be coming “very shortly,” after previously exempting drugs from his earlier levy announcements. “We’re gonna do...
View ArticleNovo Nordisk looks to Brazil to boost GLP-1 manufacturing with $1B+ budget
Novo Nordisk is pouring 6.4 billion Brazilian reais ($1.05 billion) into a factory in Brazil, to ramp up production of its blockbuster GLP-1 drugs after it forecast relatively sluggish growth earlier...
View ArticleIdorsia’s blood pressure pill no longer requires a REMS; Solu raises $41M
Plus, news about Vincerx and Cytora: Idorsia’s Tryvio gets safety restriction removed: Patients taking Idorsia’s blood pressure pill no longer have to take part in a drug safety program. The FDA ...
View ArticleBiotech market meltdown will leave some startups looking at survival playbook
It’s a biotech environment without many good choices. Even before President Donald Trump’s tariff announcement pushed stock indices toward a bear market, biotech M&A has been virtually nonexistent,...
View ArticleICER outlines ways to increase GLP-1 access as costs rise
The Institute for Clinical and Economic Review, the nonprofit drug pricing watchdog, released a new report on Wednesday outlining potential federal policy solutions to increase access to blockbuster...
View ArticleFirings of HHS' probationary workers can proceed, appeals court says
HHS and 19 other government agencies can follow through with firing thousands of probationary workers after a federal appeals court paused a lower court's order. Wednesday's ruling by the US Court of ...
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