'Serious liver injury' cases on Ocaliva lead FDA to call for monitoring
The FDA said it continues to monitor the safety of Intercept Pharmaceuticals and Alfasigma’s rare liver disease drug Ocaliva after seeing evidence of “serious liver injury” in a post-approval clinical...
View ArticleFDA adcomm reviews safety signals from pediatric RSV trials
Advisors to the FDA had difficulty dissecting a small but concerning set of safety data from Moderna’s pediatric RSV vaccine data, largely concluding that other trials should continue to better inform...
View ArticleEditas to cut 65% of workforce, officially stops work on ex vivo sickle cell...
Editas Medicine will eliminate about 180 roles after failing to find a commercial partner for its experimental sickle cell therapy, and will halt development of the treatment, the company said...
View ArticleGilead names Dietmar Berger CMO as it eyes turnaround
Gilead Sciences has tapped Sanofi’s Dietmar Berger as its next chief medical officer in a bid to shake up its strategy at the tail end of a mostly negative year. The new CMO will join ...
View ArticleiTeos drops adenosine A2A antagonist inupadenant to double down on TIGIT
iTeos Therapeutics will set aside inupadenant following lackluster mid-stage data in non-small cell lung cancer. The company will focus on its TIGIT therapies instead, with its recent positive data...
View ArticleXaira hires former Roche exec as CMO; 'Tis the season for retirements at...
The billion-dollar AI-focused startup Xaira Therapeutics deepened its C-suite this week, hiring former Roche executive Paulo Fontoura as its chief medical officer and internally promoting co-founder...
View ArticleAbbVie makes another small I&I acquisition, buying Nimble for $200M
In an attempt to continue its I&I dominance beyond Humira, Skyrizi and Rinvoq, AbbVie is buying up another small autoimmune startup. The Chicago-area pharma giant is dishing out $200 million...
View ArticleEisai subsidiary nabs Japan rights for schizophrenia drug; Novavax's $50M...
Plus, news about Candel, Inovio and RemeGene: Eisai licenses Newron Pharmaceuticals’ evenamide: Eisai’s subsidiary EA Pharma will pay up to €117 million ($123 million) in upfront and milestone fees for...
View ArticleRepare plans for Phase 3 endometrial cancer study, sidelining ovarian cancer
Repare Therapeutics announced that a combination of two targeted drugs resulted in confirmed responses of 19% and 17% in endometrial cancer and ovarian cancer, respectively, and now plans to take the...
View ArticleSABCS Roundup: BeiGene and Pfizer CDK4 inhibitors, ALX’s CD47
This year’s San Antonio Breast Cancer Conference yielded major clinical updates on some of the hottest areas of oncology, from VEGF bispecifics that hope to challenge Merck’s Keytruda on efficacy to ...
View ArticleBeiGene licenses MAT2A cancer drug, matches with Ideaya’s combo plans
BeiGene said it will take on an early-stage drug for solid tumors with MTAP deletion for $150 million upfront and "time-based payments," in a move that would put it in a contest with Ideaya’s combo ...
View ArticleBoundless shares dip as it nixes cancer asset, reshuffles execs
Boundless Bio is trimming its oncology pipeline in the wake of disappointing cancer data and switching up its leadership just eight months after debuting on the Nasdaq. The San Diego-based biotech has...
View ArticleEMA's committee says expanded label for Lilly's Mounjaro into sleep apnea not...
The European Medicines Agency’s human medicines committee (CHMP) handed down 17 recommendations for drug approvals on Friday but said a label expansion of Eli Lilly's blockbuster diabetes drug Mounjaro...
View ArticleBicycle Therapeutics stock sinks following cancer data
Bicycle Therapeutics shared several batches of data for its bicyclic toxin conjugate in metastatic urothelial cancer, non-small cell lung cancer and breast cancer, but the response rates for the drug...
View ArticleFDA stands by mifepristone safety label in federal court challenge
The FDA is pushing back against claims that its safety restrictions for the abortion pill mifepristone are “onerous and medically unnecessary.” In response to a lawsuit filed last year by several...
View ArticleMcKinsey fined $650M for deceiving US on opioid consulting
McKinsey has accepted a $650 million fine after admitting that it helped accelerate sales of Purdue Pharma's opioid products and misled the US government about its conflict-of-interest policy, allowing...
View ArticleOrganon's steroid-free cream Vtama wins approval in atopic dermatitis
Organon won a label expansion on Friday for the steroid-free topical cream it picked up from its October acquisition of Dermavant. Vtama, also known as tapinarof, is now approved to treat adults and...
View ArticleFTC OKs Novo-Catalent deal, in major win for Novo Nordisk’s GLP-1 manufacturing
After some delay, the Federal Trade Commission has approved Novo Holdings’ $16.5 billion acquisition of Catalent, a week following the European Commission's go-ahead. Now that both regulatory parties...
View ArticleThe Endpoints 100 is back; Inside Isomorphic Labs; FDA adcomm discusses...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleRoche terminates a Phase 3 Spark gene therapy in hemophilia A
Roche has officially discontinued a Phase 3 hemophilia A gene therapy from its Spark Therapeutics unit, a spokesperson for the Swiss pharma told Endpoints News on Friday afternoon. The drugmaker...
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