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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Maryland-based United Therapeutics said Sandoz has had eight years to ensure it had its own delivery system in place for its generic pulmonary arterial hypertension medication.
The new initiative against opioids has a goal of reducing related deaths by as much as 40 percent.
FDA grants elafibranor Breakthrough Therapy Designation, based on Phase 2 data, for treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA
Director Peter Marks said FY18 was productive and exciting as the FDA department continued to support the advancement of 21st century medicine.
COPD is a progressive disease associated with tobacco smoking, air pollution or occupational exposure. It results in difficulties in breathing and increasing episodes of breathlessness.
As Ned Sharpless takes over as acting commissioner of the U.S. Food and Drug Administration, he is not planning any disruptions or course corrections to the federal regulatory agency.
Poietis, 4D Bioprinting company, announces the issuance by the European Patent Office of a third patent covering its bioprinting technology
Company on Track to Submit NDA to FDA in Mid-2019
Karolinska Development’s portfolio company Aprea Therapeutics has from FDA received an Orphan Drug Designation for APR-246 for the treatment of patients with Myelodysplastic Syndromes having a TP53 mutation.
MediciNova, Inc. announced that the U.S. Food and Drug Administration has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166 in amyotrophic lateral sclerosis.