Endpoints livestream: What Vinay Prasad means for CBER and FDA
Today at 11 a.m. ET, we're going to talk about the surprise news that Vinay Prasad will replace Peter Marks at the FDA, and lead the Center for Biologics Evaluation and Research ...
View ArticleTheriva’s oncolytic virus succeeds in pancreatic cancer study, but stock falls
Theriva Biologics' experimental oncolytic virus treatment and chemotherapy helped patients in a mid-stage study stay alive longer than chemotherapy alone. The company said Wednesday that the Phase 2b...
View ArticleCedars-Sinai partners with Redesign Health to build health tech startups
Los Angeles-based health system Cedars-Sinai is partnering with venture studio Redesign Health to build health tech startups from scratch, among other initiatives. The non-profit network of hospitals...
View ArticleEuropean regulators to review Valneva shot; Jazz's stock dips on subpar...
Plus, news about NewAmsterdam, C4 Therapeutics, Vivo Capital, and Arcus Biosciences: EMA to conduct safety review of Valneva vaccine: European regulators will review Ixchiq, Valneva’s live attenuated ...
View ArticleCharles River launches ‘strategic review’ alongside activist investor Elliott
Charles River Laboratories is set to start a strategic review and add four new board members after it settled on a “cooperation agreement” with Elliott Investment Management. The Wednesday announcement...
View ArticleJudge hands win to FDA, Lilly in tirzepatide shortage case
A federal court handed the FDA and Eli Lilly a major win in a case challenging the end of the tirzepatide shortage. On Wednesday, The US District Court for the Northern District of Texas denied ...
View ArticleDrugmakers to push back on Trump plan for 'most favored nation' prices
It was Wednesday afternoon last week at the White House, and President Donald Trump was working the room. There with him were CEOs from the world’s biggest companies, all of whom had pledged billions...
View ArticleAvadel can seek to expand Lumryz's label after court ruling
Avadel Pharmaceuticals can try to expand the use of its blockbuster narcolepsy drug after a federal appeals court overturned an order that had barred it from filing for FDA approval for use in...
View ArticleFDA adcomm to review drugs for four different cancers this month
The FDA announced a two-day meeting of its Oncologic Drugs Advisory Committee (ODAC) later this month to review four cancer drugs from Genentech, Pfizer, J&J and UroGen Pharma, with potential new ...
View ArticlePhRMA warns against tariffs as industry probe closes for comments
A leading pharmaceutical trade group urged the Department of Commerce not to place tariffs on the sector as the window for feedback on the trade probe draws to a close. “Tariffs are not the answer ...
View ArticleTeva plans staff cuts as it commits to accelerating growth
Teva is planning to reduce its headcount by 8% by 2027, the company announced on Wednesday, as it enters the next phase of its yearslong "pivot to growth" plan. The cuts will impact manufacturing and ...
View ArticleGilead reveals plans to put another $11B into US manufacturing
Gilead is the latest pharma company to announce that it’s pouring billions of dollars into its manufacturing and R&D operations in the US. The company said Wednesday that it’s investing a ...
View ArticleFDA will convene vaccine advisors to discuss Covid strain updates
FDA advisors will meet later this month to discuss which Covid-19 strain vaccine makers should target ahead of the the fall and winter, when infections tend to spike. The May 22 meeting, disclosed in a...
View ArticleLantheus culls late-stage Lilly-partnered prostate cancer radioligand
Lantheus finally came clean about the fate of its experimental radiopharmaceutical for prostate cancer, confirming Wednesday that it has dropped the asset. The company had licensed the β-emitter, known...
View ArticleHAYA Therapeutics gets $65M for 'dark genome' work following last year's...
After working off $20 million in seed funding for about four years, HAYA Therapeutics tapped the funding well and came back with $65 million to get its cardiac fibrosis treatment candidate into human...
View ArticleCRISPR isn’t living up to its potential. Two scientists have a plan to fix that
Fyodor Urnov had given a version of his speech dozens of times before. Yet as he leaned into the microphone to address the FDA’s top regulators late last year, he felt his heart racing. The ...
View ArticleBlood cancer biotech Vor Bio ends clinical work, lays off 95% of staff
Vor Bio, founded by famed cancer biologist Siddhartha Mukherjee, is looking for a way out. After attempting to shake up how blood cancers are treated with cell and genome engineering, Vor has now...
View ArticleALX Oncology won’t seek approval for CD47 drug in gastric cancer; Korro Bio’s...
Plus, news about Cognition Therapeutics, Sagimet Biosciences, BeiGene, Hikma and Rallybio: ALX Oncology won’t pursue approval in gastric cancer: The company had been aiming to get its CD47-targeting...
View ArticleBristol Myers' $40B US investment; Shionogi to buy Japanese drugmaker
Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Bristol Myers Squibb said it is committing $40 billion over the next...
View ArticleVerastem wins first FDA approval for ovarian cancer therapy
Boston-based Verastem Oncology on Thursday won accelerated approval from the FDA for Avmapki Fakzynja as a second-line treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian...
View Article