Policy

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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FDA
The latest approval for Calquence, a Bruton tyrosine kinase inhibitor, was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programs.
The analysis said that if the Pelosi plan were to become the law of the land, it would cut revenues by more than half for companies with affected medicines and would also lead to a “nearly 90% reduction in new medicines” developed by those smaller U.S.-based companies.
FDA
The approval marks the first time a Korean company independently brought a drug from discovery to FDA approval.
The AP report shows that in China, Mundipharma representatives are informing doctors that OxyContin is less addictive than other painkillers, which is a similar tactic the company used in the 1990s in the United States.
FDA
The U.S. Food and Drug Administration approved Alnylam Pharmaceuticals’ Givlaari (givosiran) for acute hepatic porphyria.
Heidelberg Pharma contributing Antibody Targeted Amanitin Conjugate technology for Emergence Therapeutics antibody target
Mitchell Hamline School of Law is pleased to announce the first annual Roy Snell Health Care Regulatory & Compliance Writing Competition.
Synergistic Therapeutics LLC has recently announced the issuance of a U.S. Patent for a Topical Analgesic Lotion that relieves pain.
The bankruptcy court gave approval to the reimbursement of legal fees for states and local governments involved in the opioid lawsuit settlements, but with the understanding that would allow $200 million in emergency funds to flow to treatment programs.
KidneyX seeks breakthrough solutions to transform kidney care