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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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After a negative review by an Independent Data Monitoring Committee, InDex Pharmaceuticals has decided to discontinue the late-stage CONCLUDE program evaluating its cobitolimod in ulcerative colitis.
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.