BIO CEO on tariffs, MAHA and the future of the biotech industry
John Crowley is clear-eyed about the obstacles he faces. As CEO of the trade group BIO, he’s been tasked with mounting a political comeback for an industry that has taken its punches from Democrats and...
View ArticleEli Lilly adds obesity startup knownwell to its direct-to-consumer service
Eli Lilly’s direct-to-consumer service has added another telehealth startup to its line-up of providers who can prescribe its medications, as it prepares to see more demand for obesity drugs following...
View ArticleNew FDA Commissioner Marty Makary addresses staff a day after firings
New FDA Commissioner Marty Makary took to the stage at the regulator's Maryland headquarters on Wednesday, in his first public communication to much of the agency since Tuesday's mass firings....
View ArticleFTC's fight against PBMs is paused
The FTC’s legal fight against three major pharmacy benefit managers is on hold after two agency commissioners have been removed by the Trump Administration. The commissioners, Rebecca Slaughter and...
View ArticleBiopharma execs rethink Trump impact after FDA cuts
This week’s sweeping layoffs at the FDA have caused some biopharma leaders to change their tune on the Trump administration. After President Donald Trump’s victory in November, many biopharma CEOs...
View ArticleTrump’s tariffs could leave the pharma industry scrambling
President Donald Trump on Wednesday announced broad 10% global tariffs in a move that pharma industry groups worry will upend drug costs and manufacturing. The announcement marks the administration’s...
View ArticleTrump's tariff rollout leaves many questions for drugmakers
A rapid cascade of seemingly conflicting details from President Donald Trump’s tariff announcement left large drugmakers on Wednesday trying to figure out the impact on the industry, with many...
View ArticleExclusive: Neurona bags $102M to treat epilepsy with cell therapy
A few cell and gene therapy biotechs are doing alright this week. The latest is Neurona Therapeutics, which exclusively told Endpoints News that it collected another $102 million in an upsized,...
View ArticleSarepta, Roche pause Elevidys trials in Europe following patient death
Sarepta and Roche are hitting the brakes on three trials of their Duchenne gene therapy Elevidys in response to a request by the European Medicines Agency. The drugmakers are pausing enrollment and...
View ArticleNovartis’ Chinook-originated kidney disease drug gets accelerated approval
One of Novartis’ most important clinical catalysts of the year came Thursday, with the accelerated approval in the US of its rare kidney disease drug. Atrasentan, which is now named Vanrafia, is a...
View ArticleDaymark Health raises $11.5M to care for cancer patients
Oncologist Justin Bekelman started Daymark Health to better support cancer patients outside the clinic. The startup launched on Thursday with a $11.5 million seed round co-led by Maverick Ventures and...
View ArticleMoonLake discloses up to $500M in financing; OSR’s deal with innovation fund
MoonLake Immunotherapeutics gets financing worth up to $500M: The company will get $75 million upfront from Hercules Capital. MoonLake, which went public in 2022, had about $448 million in cash before ...
View ArticleAnother TIGIT trial fails as BeiGene scraps Phase 3 drug
What was once a promising area of cancer immunotherapy has had another late-stage failure. BeiGene said Thursday that a Phase 3 study for its anti-TIGIT drug, called ociperlimab, was halted for ...
View ArticleAldeyra gets second CRL for dry eye disease drug
The FDA once again rejected Aldeyra's potential dry eye disease treatment, known as reproxalap, as the agency requested more trial data after the resubmitted drug approval request "failed to...
View ArticlePIPEs, biopharma’s favorite financing vehicle, freeze amid market struggles
PIPEs have fallen out of favor. The private investment in public equity, or PIPE, had one of the best years on record in 2024. The financing instrument has a clubby feel in which drug developers ...
View ArticleSHL Medical opens $220M autoinjector site; DHL acquires clinical trial firm
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Swiss CDMO SHL Medical has opened a new $220 million factory in ...
View ArticleRoche plans to take its latest Alzheimer's drug attempt to Phase 3
Roche on Thursday shared early positive results for its Alzheimer’s candidate trontinemab, the latest round of data in its second attempt to develop a drug for the disease. The company said it's...
View ArticleFDA will consolidate to five 'shared services offices': HHS memo
The FDA is being consolidated into five “shared services offices,” according to a memo from HHS distributed to staff on Capitol Hill that was reviewed by Endpoints News. The memo lays out a broad set ...
View ArticleCollective Health is shedding the ‘competitor’ image
On Wednesday, Providence Health Plan, which mainly operates in Oregon as part of West Coast health system Providence, said it’s working with Collective Health to offer its health plan to ...
View ArticleSenate, House committees seek to discuss HHS cuts with RFK Jr.
Just a day after HHS and many of its agencies like FDA, CDC and NIH saw thousands of job cuts, House and Senate committees that oversee the agencies have asked HHS Secretary ...
View ArticleGovernment staff supporting Trump-backed 'Right to Try' program are let go
When President Donald Trump signed the Right to Try Act into law in 2018, he vowed that it would help many terminally ill patients access new therapies that might prove life-saving. The law allows...
View ArticleFDA approves Amgen's Uplizna in IgG4-related disease
The FDA on Thursday approved Amgen’s rare disease drug Uplizna in an autoimmune disorder, setting the stage for the therapy to gain a foothold in the rare disease market. Uplizna is now approved to...
View ArticleDOJ attorney says Boehringer Ingelheim has 'tremendous leverage' in IRA...
Drugmakers have leverage and are getting “a real negotiation” with the government over the prices of products selected under the Inflation Reduction Act, a DOJ attorney argued in a case against...
View ArticleSenate confirms Dr. Oz to lead CMS
The Senate on Thursday voted 53-45 to confirm trained surgeon and former daytime TV host Mehmet Oz as the next CMS administrator, as a major reshaping of the federal healthcare agencies continues. Oz...
View Article