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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Novartis will use a priority review voucher to expedite review of the treatment that could hit blockbuster status within two years of launching.
The vast majority of immune cells are found in the gut but historically, the gut has been viewed as a liability to drug development. The question of whether or not greater understanding of harnessing the gut could drive more promising drug development has led to the formation of a new company, Kintai Therapeutics.
Auris Medical Holding Ltd. announced that the Nasdaq Hearings Panel has granted the Company’s request for the continued listing of the Company’s securities on The Nasdaq Capital Market.
TLC announced the successful completion of its End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) on receiving guidance, and discussing the clinical and regulatory pathway for a potential U.S. approval of TLC599, a BioSeizer® liposomal formulation of dexamethasone sodium phosphate for the treatment of knee osteoarthritis.
The FDA’s approval marks the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.
Developing a Human Factors Validation Plan with Consideration for the Digital Health Marketplace
Polyphor AG announced that the US Food and Drug Administration has designated murepavadin as a Qualified Infectious Disease Product in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection and complicated intra-abdominal infection.
Sprout wanted the warning regarding alcohol to be completely removed but the FDA said it must remain, although with a caveat.
Pharma and biotech companies from Asia to Europe provide updates on business and clinical activities.