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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.
While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
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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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FDA
Wednesday, the FDA approved GSK’s daprodustat, now to be marketed as Jesduvroq, for the treatment of anemia due to chronic kidney disease in adult patients.
Karuna Therapeutics acquired exclusive rights to Goldfinch Bio’s investigational TRPC4/5 channel candidates in a deal potentially worth $520 million.
Roche is dropping its investigational AKT inhibitor ipatasertib, which was being assessed in a Phase III trial for castration-resistant prostate cancer, as well as several other candidates.
Novartis is cleaning house, cutting its Huntington’s disease program along with several others. The company announced multiple program stops and delays in its full-year 2022 report Wednesday.
The partners will combine Miromatrix’s single-use bioengineered liver with Baxter’s PrisMax system, which is designed to provide individualized therapies to patients.
GSK has dropped two assets, an investigational celiac disease therapeutic and a Staphylococcus aureus vaccine hopeful, from its pipeline.
The FDA asked Taysha Gene Therapies to dose more patients in a double-blinded, placebo-controlled trial before submitting a BLA for its giant axonal neuropathy candidate.
FDA
As the 118th Congress kicks into gear, biopharma industry observers speculate that 2023 may be a challenging year.
Now more than ever, there is ample opportunity for life science candidates with only a bachelor’s degree. Still, there are certain things these candidates should know to ensure their success.
uniQure inked a deal with Apic Bio to gain development and commercialization rights to APB-102, a gene therapy for a rare, genetic form of ALS.