News
Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
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Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
Analysts homed in on Duchenne muscular dystrophy and myotonic dystrophy type 1 assets during first quarter earnings as major players like REGENXBIO and Novartis as well as Dyne, Wave, Solid and Sarepta near the regulatory finish line.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Amgen announced two lung cancer studies with mixed results, Innovent dosed the first patient in a Phase I diabetic macular edema study and HUTCHMED hit the primary endpoint in colorectal cancer.
This week’s Movers & Shakers include Scribe, Appia Bio, Chimerix and KemPharm, all announcing new VP roles. Companies also plan for the future with the implementation of a succession plan.
The makers of ranitidine-based products, such as Sanofi, GSK and Haleon, are reeling from lawsuits related to carcinogenic contamination that could result in billions of dollars in damages.
Centessa halted ZF874 following the report of an adverse event that involved elevated liver enzymes in a Phase I study. This is the second development program the company has stopped in as many months.
A new study on Alzheimer’s disease ties the brain’s immune response to the condition, while scientists have identified a better antibody treatment for cancer and more research news.
Panacell Biotech plans to initiate a program to investigate the use of natural killer (NK) immune cells, exosomes and brown adipose-derived stem cells to treat Long COVID.
Vyne Therapeutics’ combination therapy for atopic dermatitis failed to meet the primary endpoint in a Phase II trial, leaving the company evaluating its priorities and pipeline.
MaaT Pharma announced that the U.S. FDA has maintained the clinical hold on MaaT013, its candidate for patients with steroid-resistant acute graft-versus-host disease.
Versant Ventures launched Vector BioPharma, a company developing a “precision gene delivery platform that is devoid of viral genes.” Rani, REVA Medical and Summit Therapeutics also scored funds.
Gemini Therapeutics and Disc Medicine have announced plans to merge in an all-stock deal. The combined company will work to advance Disc’s pipeline of hematology programs.