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Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy, while VBL received Fast Track designation for an ofra-vec combination in ovarian cancer.
How many boosters are enough to protect against COVID-19 infection? This question has been at the forefront of the minds of everyone as news crops up about yearly boosters.
Gamida Cell reported that the FDA had lifted its clinical hold on its cryopreserved formulation of GDA-201. It expects to launch a Phase I/II drug trial for those indications this year.
With $67 million in Series A financing, newly-launched Apertura plans to develop genetic medicines using technologies that address key limitations of gene delivery and expression.
The war has shattered plans for a variety of clinical trials, but Roche is particularly concerned about fenebrutinib, a drug it is developing for multiple sclerosis (MS).
Protagonist Therapeutics’ Phase II study of an ulcerative colitis treatment failed to meet its primary endpoint at a higher dosage amount. Even so, the company remains optimistic about the drug’s future.
Nektar Therapeutics outlined a strategic reorganization plan that includes cutting 70% of its workforce. This comes only weeks after BMS abandoned its clinical collaboration program with Nektar.
Pfizer and its partner, Valneva, have announced positive Phase II data from its trial of vaccine candidate VLA15 in a pediatric population. VLA15 is intended to prevent Lyme Disease (LD).
The first quarter hasn’t been kind to international biopharmaceutical firms. BioSpace takes a look at the fates of Saniona and Black Diamond below.
Triebel holds the distinction of having discovered LAG-3 in 1990. Today, the company he founded is leveraging the handy molecule against cancer and autoimmune disease.