Boundless 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...
View ArticleBristol Myers drops cell therapy pacts with Immatics, Century as part of...
Bristol Myers Squibb is ending a pair of cell therapy collaborations with Immatics and nixing a separate agreement with Century Therapeutics for natural killer cell and T cell-based cancer treatments....
View ArticleNovo Nordisk to spend $1.2B for new rare disease drug factory in Denmark
Just days after winning FTC approval to take on three of Catalent’s facilities, Novo Nordisk said it is investing DKK 8.5 billion ($1.2 billion) to build a new factory in Denmark to ...
View ArticleBiohaven’s protein degrader cuts antibodies by 60%
Biohaven said the lowest dose of BHV-1300 cut the levels of the autoimmune antibody IgG by more than 60%, according to a new cut of data from an ongoing multiple ascending dose trial. This falls ...
View ArticlePureTech declares mid-stage trial win for pulmonary fibrosis drug
PureTech Health unveiled positive Phase 2b data on Monday for its idiopathic pulmonary fibrosis drug, which showed it can reduce lung function decline in patients. The drug hit the trial's primary ...
View ArticleCandid inks three T cell engager deals; PepGen trial put on hold
Plus, news about Foghorn Therapeutics, Incyte, BioNTech, Galderma, Basilea, Innovia, Pharming, bit.bio, Promise Bio, Outlook Therapeutics and Trevi Therapeutics: Candid Therapeutics’ trio of T cell...
View ArticleCheckpoint wins FDA approval of checkpoint inhibitor in advanced skin cancer,...
The FDA approved Checkpoint Therapeutics’ anti-PD-L1 antibody cosibelimab in a form of advanced skin cancer, the company announced Friday. The immune checkpoint drug will be marketed as Unloxcyt and...
View ArticleNeurocrine gets FDA approval in rare adrenal gland condition
A turbulent 2024 for Neurocrine is ending on a high note, after the biotech won FDA approval to treat congenital adrenal hyperplasia, a condition marked by adrenal gland dysfunction. The Friday
View ArticleHRSA pushes back against another 340B rebate model, this time from Sanofi
The US Health Resources and Services Administration on Friday warned Sanofi against implementing its planned rebate model for some of its outpatient drugs under the drug discount program for low income...
View ArticleWhat a Trump FTC means for biotech and pharma dealmaking
President-elect Donald Trump’s two picks for the Federal Trade Commission are likely to usher in more life sciences deals while maintaining the agency’s pressure on pharmaceutical intermediaries. A...
View ArticleViridian readies for Tepezza rivalry with new Phase 3 data in thyroid eye...
Viridian Therapeutics’ stock jumped Monday after the company unveiled another Phase 3 look at its potential competitor to Amgen's Tepezza in thyroid eye disease. Veligrotug met all its primary and...
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