Policy
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.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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The approval of Piqray combined with fulvestrant is the first FDA-approved treatment for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.
The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.
The approval of Jakafi marks the first approved treatment for this indication in the United States.
The administration sees the push for transparency as a tool to help consumers control the costs of their health care.
Shares of NovoCure are up more than 6% in premarket trading after the company announced it won regulatory approval for its mesothelioma treatment, NovoTTF-100L System.
ADL Bionatur Solutions recently reported Q119 results, showing positive €0.11m EBITDA, and over 134% year-on-year revenue growth to €10m, driven by 180% growth in contract manufacturing.
InflaRx reported financial and operating results for the first quarter ended March 31, 2019.
Medtronic plc announced financial results for its fiscal year and fourth quarter 2019, which ended April 26, 2019.
Singapore-based researchers have discovered a possible solution to impede the evolution of bacteria into superbugs that are resistant to drugs and therefore harder to kill.
Researchers from Singapore have designed the world’s first ‘molecular swing’ to transport electrolytes across cell membranes.