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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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.
uBiome said it “does not have any control over physician billing. Any improper billing by physicians, if it occurred, is not related to uBiome’s billing practices,”
Four biotech companies recently filed with the U.S. Securities and Exchange Commission their plans for initial public offerings (IPO). Let’s take a look.
The NDA was based on positive Phase III data that shows the once-a-month treatment is as effective as the daily standard of care.
Ireland-based Horizon Pharma reported additional statistically significant secondary data from its positive Phase III study at a conference and plans to continue to share analysis at future medical conferences.
This week has a number of approvals expected by the U.S. Food and Drug Administration. Let’s take a look.
In September 2018 a leap forward in treating burn victims was made with the approval of Avita Medical’s RECELL Autologous Cell Harvesting Device. The Food and Drug Administration (FDA) green lit the California-based company’s burn treatment device that uses a small amount of a patient’s own skin to prepare what is called Spray-On Skin Cells.
Bausch Health, former known as Valeant Pharmaceuticals International, announced that the U.S. Food and Drug Administration (FDA) had approved its Duobrii (halobetasol propionate and tazoretene) Lotion for plaque psoriasis.