Clinical Trials
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Regeneron Gene Therapy Reaches New Heights In Restoring Hearing
The US biotech’s DB-OTO has made headlines worldwide after a baby with profound genetic deafness experienced improved hearing to normal levels within 24 weeks after a single intracochlear injection.
Chinese Drug Makers Trim, Boost Pipelines In New R&D Drive
The ranks of B7-H3-targeting antibody-drug conjugates under development in China have seen their first dropout, although elsewhere there are two FGFR2b-directed ADCs with first-in-class potential on the horizon. Meanwhile, there have been other discontinuations of KRAS G12C inhibitors and anti-BCMA CAR-T cell therapies in the country, while new players have surfaced in the areas of mRNA cancer vaccines and amyloid-beta-targeting antibodies for Alzheimer’s disease.
Publisher’s Spotlight: The Winners Of The 2024 Citeline Awards
Congratulations to the winners of the 2024 Citeline Awards, held 8 May in Boston.
Teva Starts The Year With Phase III Data And Growth
Teva reported positive Phase III data for a long-acting version of olanzapine for schizophrenia, coinciding with its first quarter sales and earnings release.
Hibernating Squirrels And Exercise In A Pill: The Next Wave of Cardiometabolic Therapies
Early-stage companies pioneering new modalities discussed the future of cardiometabolic therapy and partnering with big pharma at the LSX conference in London.
BioNTech Ramps Up Spending To Launch 10 Pivotal Cancer Studies In 2024
As COVID-19 vaccine sales decline, the company is investing billions in a diverse oncology pipeline including antibody drug conjugates, immunotherapy and cancer vaccines
Calliditas Confident Of Setanaxib's Potential Despite Unclear Data
The Sweden-headquartered biotech has emphasized the promising survival data in a head and neck cancer study of setanaxib rather than the NOX inhibitor’s inability to shrink tumors.
Pipeline Watch: Six Approvals And 13 Phase III Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
GlycoMimetics Forges Ahead With Uproleselan In AML After Phase III Failure
The company said an NCI trial and a China study remain ongoing despite a Phase III study in relapsed/refractory disease failing, with an unusually long OS result in the control arm.
The UK’s Cancer Vaccine Partnership With BioNTech Is Another First – But Can It Deliver?
BioNTech and the UK government's alliance to bring personalized cancer immunotherapy to patients is making progress, but the National Health Service has to show it can deliver on clinical trials recruitment.
Amgen Planning Pivotal Obesity Program For MariTide
Executives said during Amgen’s Q1 call that the company is “encouraged” by interim Phase II data for MariTide (AMG 133) in obesity, so it is designing Phase III trials and building manufacturing capacity.
Annovis Faces A Race Against Time
Buntanetap has flopped in Alzheimer’s disease, making an upcoming Parkinson’s trial a must-win. But there are reasons to doubt the outcome of this study, and Annovis is running out of money.
Newron’s Add-On Treatment Shows Promise In Newly Popular Schizophrenia Field
Newron’s evenamide worked in a Phase II/III trial as an add-on to antipsychotic drugs in patients with inadequate response to monotherapy at a time when schizophrenia has piqued the interest of big pharma.
Podcast: Facilitating Patient Monitoring in CAR-T Development
The US FDA recently initiated class safety labeling changes after evaluating the safety of CAR-T cancer treatment therapies. What does this mean for developers in the CAR-T landscape? Listen to your free podcast to find out.
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: 2023’s top selling drugs and the COVID cliff; falling sales force Roche to reassess priorities; Phase III immunology win for Sanofi; BMS’s strong pipeline: and which companies could be acquired next.
AstraZeneca And Daiichi Get Low
A hit with Enhertu in an earlier setting in HER2-low breast cancer patients, and in ultralow expressers, heightens expectations.
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