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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The FDA on Monday released new draft guidance on conducting multi-regional oncology trials, saying its “paramount consideration” is whether the results apply to the intended use population and standard...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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#ESMO24: 23andMe heads to ESMO to tout its two clinical-stage drugs after...
BARCELONA — A month after gutting its internal drug discovery group, 23andMe is trudging along with the experimental medicines it’s already brought into the clinic. 23andMe has struggled with its dual...
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Emmet Stephenson gives $150M to City of Hope for pancreatic cancer, creating...
In honor of his wife who passed away from pancreatic cancer, tech entrepreneur Emmet Stephenson and his daughter Tessa Stephenson Brand are donating $150 million to City of Hope. The majority of the...
View ArticleNura Bio raises $68M for clinical tests of SARM1 inhibitor to potentially...
A promising new approach that could slow, stop or prevent nerves from dying may get its first test in patients next year. Nura Bio, a startup based in South San Francisco, has developed an oral small...
View ArticleMerck and Daiichi’s rejected HER3 ADC clears a Phase 3 in certain lung cancers
BARCELONA — Merck and Daiichi Sankyo have passed a Phase 3 with the lead antibody-drug conjugate from the megadeal they disclosed at last year’s European Society for Medical Oncology confab. The new...
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#ESMO24: After landing a key win in a common cancer condition, Pfizer faces a...
BARCELONA — One of this weekend’s sleeper data presentations at Europe’s biggest oncology conference puts Pfizer in a leading position in a common cancer condition with no approved treatments in the US...
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#ESMO24: Sun, surprises and new summits at Europe’s biggest cancer conference
BARCELONA — More than 33,000 oncologists, medical researchers, biopharma leaders and other delegates attended Europe’s largest cancer meeting over the past few days in Spain, with more than 181...
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Bad trip: How culture conflict and a need for cash nearly broke Lykos
In early 2023, the founder of the psychedelic medicine company Lykos Therapeutics met with a potential investor for dinner, feeling out the chemistry for a financial — and personal — relationship that...
View ArticleCigna sues FTC, calling for withdrawal of 'biased, erroneous' PBM report
Cigna, the owner of one of the top pharmacy benefit managers, is suing the Federal Trade Commission and Commissioner Lina Khan, and asking them to pull a July report that slammed the drug industry...
View ArticleCapricor expands DMD pact with Nippon Shinyaku; AbbVie’s new eye deal
Plus, news about Vigil Neuroscience, AC Immune and Athira Pharma: Capricor Therapeutics, Nippon Shinyaku expand commercial pact into Europe: The new deal builds off an existing partnership for a...
View ArticleCoherus warns of limited cancer drug supply due to third-party ‘capacity...
Supplies of Coherus Biosciences’ biosimilar version of the white blood cell-stimulating drug Neulasta will be “substantially depleted” through mid-October because of production constraints at a...
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CDMO Serán sets out to build first commercial facility, with a $200M...
Small molecule contract manufacturer Serán Bioscience is building its first commercial-scale manufacturing facility, backed by a $200 million investment from Bain Capital and others. “We are pushing...
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