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#ESMO24: Pfizer tees up Phase 3 in 2025 in weight management, but in an...
BARCELONA — At a major cancer conference, Pfizer made an unexpected announcement: It has late-stage plans in weight management. But it’s not targeting weight loss like one would first think amid the...
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#ESMO24: Incyte gears up to face FDA once again with more Zynyz data in rare...
BARCELONA — Incyte said it has positive late-phase results for its PD-1 drug Zynyz in certain patients with squamous cell carcinoma, three years after the FDA asked for more data. The Phase 3...
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#ESMO24: Scorpion details early data that helped it raise $150M for PI3Kα...
BARCELONA — In a first test of Scorpion Therapeutics’ therapy for breast cancer and other solid tumors, a small group of patients saw their tumors shrink following treatment with no severe cases of...
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#ESMO24: AstraZeneca unveils what it calls ‘practice-changing’ Imfinzi data...
BARCELONA — In a result that’s likely to change how some bladder cancer patients get care, AstraZeneca said that its drug Imfinzi boosted patient survival alongside chemotherapy and surgery. Two years...
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#ESMO24: Keytruda and Lenvima still have a hill to climb following latest...
BARCELONA — Merck’s bumpy six-year relationship with Eisai’s anti-cancer medication Lenvima landed on somewhat better footing in Spain over the weekend, but the duo is not out of the clear yet....
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#ESMO24: In surprise, study suggests Covid mRNA vaccines may boost cancer...
The mRNA-based Covid vaccines used by hundreds of millions of people may provide an unexpected benefit to some cancer patients, significantly improving survival when given within a few months of...
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Biotech IPO market still in flux following flashy Friday tripleheader
Three clinical-stage biotechs, three upsized offerings and three first-day share spikes. Last Friday’s biotech IPO tripleheader was a multiyear rarity for an industry still grasping for a more lively...
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#ESMO24: Exelixis’ drug staves off neuroendocrine tumor progression in broad...
BARCELONA — A new treatment option for a wide range of patients diagnosed with neuroendocrine tumors could be approved in April, as final results of a Phase 3 study on Exelixis’ cabozantinib were...
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#ESMO24: Merck's Eliav Barr on subcutaneous Keytruda, Summit's data, 'fetch...
BARCELONA — In the span of 30 minutes, 29-year Merck veteran Eliav Barr can analogize drug development dealmaking to Reese’s candy, call himself an “old fart” when asked about career plans, get real...
View ArticlePhysical therapy startup Sword Health shifts to a novel way of getting paid
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) An AI-powered digital physical therapy startup is the latest health tech company to switch to a...
View ArticleImmatics loses Bristol Myers' support on Phase 1 bispecific T cell engager
BARCELONA — Immatics presented more clinical data on its bispecific T cell engager at Europe’s largest cancer conference. But the German and US biotech is losing its partner on the Phase 1 drug, which...
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Ex-Kite leaders step in at Kyverna as CEO exits after landing year's...
Kyverna Therapeutics has reshaped its C-suite just seven months after securing one of the splashiest biotech IPOs in recent years as it rode the waves of cell therapy’s expansion into the autoimmune...
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Ochre Bio CEO Jack O’Meara steps down, outlines plans for next startup
Jack O’Meara announced on LinkedIn Monday that he is stepping down from the CEO post at Ochre Bio, the liver disease startup he co-founded. In an interview with Endpoints News, he teased plans for a...
View ArticleNuvalent's $350M offering; FDA lifts partial hold on Zentalis drug
Plus, news about Ascendis Pharma, Korro Bio, Novo Nordisk and Medexus: Nuvalent offers $350M in shares: The oncology biotech is looking to capitalize on a swell of investor interest, with its share...
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#ESMO24: BioNTech rolls out Phase 2 lung cancer data as VEGF bispecifics take...
BARCELONA — Last week, Summit and Akeso set the industry abuzz after their bispecific antibody beat Merck’s Keytruda in a Phase 3 lung cancer trial. Now, BioNTech is touting mid-stage data for its own...
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Roche outlines commercial manufacturing strategy for GLP-1/GIP assets
Roche has already budgeted for future commercial manufacturing builds and established a network of contract manufacturers as it preps for the launch of its GLP-1/GIP drugs. The company discussed its...
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Boehringer Ingelheim touts Phase 3 topline data for its pulmonary fibrosis drug
A Phase 3 trial investigating Boehringer Ingelheim’s nerandomilast in idiopathic pulmonary fibrosis hit its primary endpoint, according to topline data revealed Monday. Based on the data, Boehringer...
View ArticleFDA approves Lilly's eczema drug Ebglyss for moderate-to-severe disease
Eli Lilly’s drug lebrikizumab has been approved for the treatment of eczema, or atopic dermatitis, a win for the company after the FDA rejected the drug last year over issues with a contract...
View ArticleFDA tells oncology companies how to run multi-regional cancer trials with a...
The FDA on Monday released new draft guidance on conducting multi-regional oncology trials, saying its “paramount consideration” is whether the results apply to the intended use population and standard...
View ArticleEuropean regulators fortify single-arm trial advice, but underscore...
The European Medicines Agency has solidified its recommendations to drugmakers that want to use single-arm designs in a pivotal trial, but emphasized that any such case “needs justification.” The...
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