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 U.S. 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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Initiative highlights commitment to the highest health and safety standards in the workplace in cooperation with the American Hospital in Dubai
German chemical company BASF, the world’s largest chemical producer, has registered 47 percent of patented marine organism gene sequences, according to a study published in Science Advances in June.
Bragar Eagel & Squire, P.C. announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of all persons or entities who purchased or otherwise acquired Alnylam Pharmaceuticals, Inc. (ALNY) securities between February 15, 2018 through September 12, 2018 (the “Class Period”).
Without regard for clear Congressional intent, the United States Drug Enforcement Administration (DEA) continues to act contrary to the express authorizations provided for in Section 7606 of the Agricultural Act of 2014 (the “Farm Bill”) and the Ninth Circuit Court of Appeals’ order in HIA v. DEA III (April 2018).
Netherlands Enterprise Agency grants through a financial loan (“Innovatiekrediet”) €2.7 million for the development of a diagnostic skin cancer test.
FDA
It looks to be a pretty busy week for the U.S. Food and Drug Administration (FDA), with a number of target action dates for various drugs. Some were delayed, and some were already approved, but there are still a number on the schedule. Here’s a look.
Advanced Bifurcation Systems today announced that the Company has submitted a proposal to the U.S. Federal Drug Administration (“FDA”) for a clinical study leading to an IDE for its bifurcation technology. Concurrently, the Company is defining a regulatory and clinical strategy for Europe to receive a CE mark.
Advanced Bifurcation Systems today announced that the Company has been granted four additional patents, three in the U.S. and one in Europe.
A study aimed at demonstrating the clinical superiority of THN201 over a standard of care treatment for this severely debilitating symptom
FDA
The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s Emgality (galcanezumab-gnlm) for migraine prevention.