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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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Pfizer and BioNTech scored a win over Moderna on Tuesday as the European Patent Office decided that a key patent held by the Massachusetts biotech related to its COVID-19 vaccine is invalid.
J&J, AbbVie, Genmab and Genentech are presenting new data at next month’s American Society of Hematology meeting on the therapeutic potential of their therapies in multiple myeloma and mantle cell lymphoma.
CRISPR gene-editing has had its first ever approval in the UK. Will the FDA follow suit? What can patients expect the price tag to be?
When twins Kenzie and Kaylie were diagnosed with Rett syndrome in 2016, there was no dedicated treatment for the neurodevelopmental disorder. That changed this year with the approval of Acadia Pharmaceuticals’ Daybue.
Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.
While Amgen and Mirati are widely viewed as frontrunners to win the first front line approval, analysts—and competitors—say the field is still wide open.
Quotient Therapeutics, co-located in Cambridge, Mass. and Cambridge, U.K., will receive $50 million over two years from Flagship to study somatic genomics with an eye to finding new targets for gene therapies.
The buy brings three small molecules in preclinical development for Parkinson’s disease, amyotrophic lateral sclerosis and lysosomal storage diseases into Merck’s pipeline.
The biotech company has bought the global rights to an investigational oral CDK2 inhibitor from Ensem Therapeutics in a licensing agreement valued at up to $1.33 billion if all milestones are met.
The regulator has decided to hold an advisory committee meeting regarding BMS and 2seventy bio’s bid to move the CAR-T cell therapy into earlier lines of treatment, missing its previous target action date of Dec. 16.