Policy
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
FEATURED STORIES
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.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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.
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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.
NHS England will acquire hepatitis C drugs from the companies at competitive prices and work to identify patients around the country.
The U.S. Department of Health and Human Services Office of the Chief Technology Officer and the American Society of Nephrology have selected 15 winning teams for Phase 1 of the KidneyX Redesign Dialysis prize competition.
BioArctic AB to publish the company’s Interim Report for the period January – March 2019 on Thursday, May 9, 2019 at 08:00 a.m. CET.