FDA 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 ArticleGSK awaits Nucala decision after FDA target date passes
The FDA is still reviewing a label expansion for GSK’s respiratory drug Nucala in chronic obstructive pulmonary disease despite the May 7 target date for a decision, the company confirmed to ...
View ArticleAstraZeneca loses appeals court fight over IRA drug price negotiations
AstraZeneca lost its challenge to Medicare drug price negotiations in the first appeals court ruling on the merits of the Biden-era program. The decision, issued Thursday by the US Court of Appeals ...
View ArticleAI-focused biotech insitro cuts 22% of staff, citing 'tumultuous market'
The AI-focused biotech insitro has laid off 22% of its workforce, the company said in a Thursday statement. Founded in 2018 by CEO Daphne Koller, a leading computer scientist at Stanford University,...
View ArticleIllumina forecasts $85M in tariff costs, decrease in China sales
Illumina estimates about $85 million in costs this year related to tariffs on its DNA sequencing products, the company said Thursday during its quarterly earnings report. In addition, it expects China...
View ArticleTakeda announces handful of pipeline cuts in effort to ‘pivot resources’
Takeda revealed a handful of pipeline cuts in its fourth-quarter earnings results on Thursday, as the company focuses its attention on six late-stage programs it says could deliver billions of dollars...
View ArticleIllumina confirms SEC has closed investigation into $8B Grail deal
Illumina on Thursday said the SEC has closed its investigation into the company's $8 billion purchase of Grail and doesn't intend to pursue enforcement action, confirming Endpoints News' reporting...
View ArticleAI biotech Insilico Medicine goes for third attempt at Hong Kong IPO
Insilico Medicine is hoping to ride a recent wave of momentum for biotech startups on the Hong Kong Stock Exchange. The biotech, headquartered in Cambridge, MA, filed for ...
View ArticleCorvus' Phase 1 atopic dermatitis data prompt stock rally
Corvus Pharmaceuticals reported new Phase 1 data in atopic dermatitis that sent its stock price {$CRVS} up by as much as 35% premarket Friday. The results come from three cohorts of ...
View Article