SHL 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 ArticleF-star management takes company private, two years after $161M cash exit to...
UK antibody developer F-star Therapeutics has become a private, independent biotech. The surprise move — announced via F-star's LinkedIn page on Thursday — comes two years after a drawn-out $161...
View ArticleEli Lilly pays struggling Sangamo $18M upfront to tap gene therapy capsid
Eli Lilly is licensing Sangamo Therapeutics’ AAV capsid for an undisclosed CNS disease target, and the $18 million upfront fee should give the beleaguered biotech a much-needed cash injection. The deal...
View ArticleArvinas touts healthy volunteer data for Parkinson's disease PROTAC
Arvinas reported early-stage data for its PROTAC program in healthy volunteers, hoping the results will eventually translate to patients with Parkinson’s disease. The data, which were shared Friday...
View ArticleNovo Nordisk adjusts its leadership team; Dyne alums migrate to Crescent...
→ Camilla Sylvest has moved on from Novo Nordisk after 28 years with the Danish pharma, including more than seven years as EVP of commercial strategy & corporate affairs. In response to her exit,...
View ArticleRelay Therapeutics does third round of layoffs in nine months, affecting...
Relay Therapeutics is downsizing for the third time since July. The Cambridge, MA-based biotech is letting go of about 70 employees, a spokesperson confirmed to Endpoints News on Friday morning. Relay had
View ArticleSarepta indicates it's safe to continue Elevidys dosing in Europe; Epsilogen...
Plus, news about Vickers Venture Partners: Sarepta Therapeutics says safety board clears paused Elevidys trials: An independent data monitoring committee concluded that three studies of the Duchenne ...
View ArticleRiboX Therapeutics quietly starts first circular RNA trial
A Shanghai-based startup quietly became the first in the world to start a clinical trial for a circular RNA therapy, a cutting-edge form of genetic medicine that could provide new ways to treat chronic...
View ArticleKennedy team defends Marks firing, while 20% of staff cuts may be 'mistakes'
At least 2,000 of the 10,000 HHS employees let go this week will be reinstated because of “mistakes,” Robert F. Kennedy Jr. said Thursday. One of his top deputies on Friday for the first time ...
View ArticleStates sue NIH over alleged grant cancellations, delays
Sixteen states on Friday sued the NIH over what they called “destructive efforts” to disrupt the agency’s grant process, in the latest legal challenge against the Trump administration’s efforts to...
View ArticleChina's retaliatory tariffs on US could mean more headwinds for drugmakers
China's announcement of 34% tariffs on all US imports — a retaliation against US tariffs that were announced this week — could create more challenges for drugmakers already navigating a dampened...
View ArticleFTC chairman seeks to revive PBM case
Federal Trade Commission Chairman Andrew Ferguson said he wants to bring back the agency’s case against pharmacy benefit managers, one day after the matter was put on hold because of the Trump...
View ArticleNovavax’s approval delay may signal warning for vaccine makers
On the precipice of FDA approval, Novavax's Covid vaccine is now in limbo while a decision to approve or reject it is held up. The delay reinforces a fear from other vaccine makers about how ...
View ArticleMarks was asked to provide non-existent vaccine risk data: WSJ
Ousted FDA biologics and vaccine chief Peter Marks was asked to provide non-existent data on the risk from measles vaccines, he told the Wall Street Journal in an interview describing the events...
View ArticleGSK and Pfizer resolve RSV vaccine patent fight
GSK and Pfizer have settled a lawsuit alleging Pfizer’s RSV shot Abrysvo infringed GSK’s patents. A Pfizer spokesperson told Endpoints News that as part of the settlement,“Pfizer has been granted a...
View ArticleTrump administration leaves obesity coverage expansion out of new Medicare rule
The Trump administration finalized new policies for some Medicare programs on Friday, but left out provisions that would have expanded coverage of anti-obesity drugs to millions of patients. Provisions...
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