Policy
The $1.2 trillion budget package will now move to the Senate, which is expected to hold a vote next week.
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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Double-digit sales growth delivered by Pharma Biotech & Nutrition (LPBN) segment
Expansion to bioconjugation facility in Visp, Switzerland to meet increasing clinical, launch and commercial market demand
Patents and intellectual property protections are a big deal in the biopharma industry. One reason is simply the timeline of drugs and therapeutics. Biopharma has several unique challenges, but one of them is the patent cliff.
As 2019 enters its second half, BioSpace takes a look at some of the warning letters issued by the U.S. Food and Drug Administration to the biopharma industry.
The FDA advisory committee canceled the meeting after Intra-Cellular provided the regulatory agency with additional data. No new meeting date has been scheduled.
Braeburn has been fighting the FDA over its award of Orphan Drug Designation to another opioid use disorder treatment that will prevent competition through November 2020. More than 2 million people in the U.S. have been diagnosed with the disease.
FDA’s Sharpless Outlines Agency’s 4 Top Priorities: Tech, Hiring, Modernization and Increased Safety
In terms of modernizing frameworks, Sharpless focused on the agency’s efforts to approve generic drugs and biosimilars more quickly in order to lower drug prices. He also said the FDA needed to help the biopharma industry with “the most expensive part of drug discovery and development,” referring to clinical testing.
It is approved for adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
Despite the approval, Samsung Bioepis’ Hadlima will not be available in the U.S. until 2023, due to licensing deals with AbbVie, the maker of Humira.
Retrophin, Inc. announced it will report second quarter 2019 financial results on Tuesday, August 6, 2019 after the close of the U.S. financial markets.