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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Pharma, biotech and life science companies from across the globe share data and progress on pipelines and other company events.
The Christiana Care Health System’s Gene Editing Institute, based in Wilmington, Del., is pulling together a preliminary investigational new drug application (IND) for the U.S. Food and Drug Administration (FDA).
The CRL called for additional CMC and non-clinical information for the post-operative pain treatment. It did not specify any safety or efficacy concerns.
The FDA gave the nod to AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older in 2017.
The company disclosed the data breach in a filing with the U.S. Securities and Exchange Commission on Tuesday. The hacking occurred in March and the company said the data of about 1 percent of its total number of clients was compromised.
Nabriva Therapeutics announced that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Contepo (Fosfomycin) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.
Gene Editing Institute’s study will be a novel investigation of the use of CRISPR technology to treat K-ras-positive non-small cell lung cancer
Karolinska Development AB has published its Annual Report for 2018.
Following the capital increase and listing on Nasdaq, cash and cash equivalents totaled €314.1 million as of March 31, 2019
Teva Pharmaceuticals recalled 35 lots of bulk Losartan Potassium after a known carcinogen was discovered in the active pharmaceutical ingredient.