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Updated: GSK unintimidated by RSV vaccine uptake challenges, Shingrix US...

In the face of broader rollout challenges that could limit uptake of Arexvy, GSK said it is confident that sales for its blockbuster asset will continue to grow in the forthcoming RSV vaccine season...

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As Amgen pursues GIP antagonism, a Novo Holdings-backed biotech does the...

Amgen’s obesity data are helping more than its own stock and internal R&D efforts. The biotech, which teased Phase 2 data in May, has helped elevate the case for GIP antagonism — rather than...

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MacroGenics stops further dosing in Phase 2 prostate cancer drug trial

MacroGenics said it will no longer dose the remaining patients who could have received more in a Phase 2 trial studying its antibody-drug conjugate in prostate cancer, after a recommendation by an...

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Ideaya and Biocytogen ink $400M+ deal; Daiichi spends more on superstar ADCs

Plus, news about PepGen, Lilly, Abcellera, CastleVax and Tracon: Ideaya and Biocytogen ink deal worth $400M+: At the center of the deal is a bispecific antibody that targets both B7H3 and PTK7. The...

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Updated: Eisai says Alzheimer's drug keeps working after three years. But...

PHILADELPHIA — Ever since Eisai first revealed data from its pivotal Alzheimer’s disease study two years ago, the company has argued that treating patients with Leqembi earlier and longer would likely...

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FDA questions Zevra’s resubmitted data for rare disease drug ahead of adcomm

Ahead of an advisory meeting Friday, the FDA raised questions about the strength of human, mouse and cell data Zevra Therapeutics generated for its treatment for Niemann-Pick disease type C — a rare,...

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Takeda defends Alzheimer's pact, TYK2 potential as restructuring is in 'full...

In its quarterly update on Wednesday, Takeda executives said the Japan-based pharma giant’s $900 million restructuring is in “full swing” as the pipeline has been reconfigured to focus on late-stage...

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Sanofi sues Sarepta, alleging that Duchenne treatment Elevidys infringes on...

Sanofi is suing Sarepta Therapeutics, alleging that the company’s approved muscular dystrophy treatment infringes on its patents related to the chemical makeup of the product. Sanofi’s rare disease...

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Teva factored IRA's next round of negotiations into its growth plans

Teva is confident in the next phase of its “pivot to growth” strategy — even in the face of upcoming selections for the next round of Medicare negotiations. CEO Richard Francis announced the company’s...

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Humana is still struggling with high medical costs as new CEO Jim Rechtin...

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Humana said Wednesday that higher-than-expected medical costs haven’t let up and are likely to continue...

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ALX Oncology continues its CD47 quest, revealing Phase 2 gastric cancer data

ALX Oncology released topline results from a Phase 2 gastric cancer trial, building on an interim readout from late last year that left a glimmer of hope alive for the CD47 space. The experimental...

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Judge rejects Novo Nordisk's IRA case as pricing negotiations conclude

A New Jersey federal judge has sided with the federal government in Novo Nordisk’s lawsuit against the Inflation Reduction Act, another in a string of legal victories for the law. Judge Zahid Quraishi...

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Sage changes main endpoint in Huntington's study months ahead of readout

Sage Therapeutics is altering the primary endpoint of a Phase 2 study for its drug candidate dalzanemdor in cognitive impairment associated with Huntington’s disease, just months before trial results...

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Otsuka makes $800M acquisition of Jnana Therapeutics to expand small molecule...

Otsuka Pharmaceutical is paying at least $800 million to acquire Jnana Therapeutics, a Roche-partnered small molecule drug discovery outfit ready to put its first candidate into a pivotal trial next...

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Updated: Eli Lilly’s Zepbound reduces risk of heart failure outcomes in Phase...

Eli Lilly has declared victory in the first late-stage trial testing tirzepatide’s effect on cardiovascular outcomes, as it looks to catch up with Novo Nordisk and solidify its lead over newer entrants...

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Rare disease biotech raises $47M Series C, plans for Phase 2 trial 

Cambridge, UK-based Healx has pulled in $47 million in a Series C round and has nabbed IND clearance from the FDA to run its first Phase 2 clinical trial with an oral drug in neurofibromatosis type 1,...

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It took more than two decades for MDMA to reach the FDA. In two months, its...

Lykos Therapeutics had planned to be the first company to bring PTSD patients a much-needed new treatment. Then in May, an influential outside group raised serious concerns about how its trial was run....

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US sales for Merck KGaA’s Bavencio impacted by Padcev/Keytruda momentum in...

Following the standing ovation for Seagen and Astellas’ Padcev in combination with Merck’s Keytruda at last year’s ESMO Congress, Merck KGaA is seeing US sales erode for its urothelial carcinoma drug...

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Jim Wilson to step down from gene therapy center at UPenn, will form two new...

Gene therapy pioneer Jim Wilson will leave his academic post at the University of Pennsylvania and launch two new companies, one focused on developing rare diseases and another meant to provide...

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VC firm venBio secures $528M for ‘extremely selective’ fifth fund after...

San Francisco-based investment firm venBio plans to back about a dozen new biotech startups over the coming three years with its latest fund, disclosed Thursday morning. Aaron Royston The firm...

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