Policy

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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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Both Bayer and J&J claim the lawsuits are without merit but believe that the $775 million settlement will allow the companies to move on from costly litigation.
A U.S. Food and Drug Administration (FDA) advisory panel voted 14 to 0 against recommending Neuronix’s NeuroAD system for the treatment of mild to moderate Alzheimer’s disease.
As America continues to grapple with the opioid crisis, nonprofit advocacy group Public Citizen is calling for the U.S. Food and Drug Administration to place a moratorium on the approval of any new opioid medications.
BioArctic AB comments on the decision by Nasdaq Stockholm to halt trading in BioArctic due to large movements in the share price.
The Roche lawsuit claims that Utah-based Alliance Medical acquired the test strips through a Roche mail order plan and then resold them at a higher price.
The United Food and Commercial Workers Local 1500 (UFCW Local 1500) filed a class action lawsuit against AbbVie for allegedly using a group of patents to maintain a monopoly on its blockbuster Humira (adalimumab).
As Scott Gottlieb prepares to step down from his role as commissioner of the U.S. Food and Drug Administration, he sat down with Politico to talk about his two years at the helm of the regulatory agency and what regrets he may be leaving behind.
FDA
Hitachi Chemical Diagnostics, Inc., a global leader in multiplex allergy in vitro diagnostics, announced today that it received 510 clearance from the U.S Food and Drug Administration for its new high capacity allergy testing instrument, OPTIGEN® AP 3600TM.
The FY19 Defense Appropriation provides $7.5 million to the Department of Defense Autism Research Program to provide support for research of exceptional scientific merit and innovation with high impact that focuses on autism spectrum disorders.
Privately-held Swedish pharmaceutical company Lobsor Pharmaceuticals AB is eying the U.S. market for a potential treatment for neurodegenerative diseases such as Parkinson’s disease.