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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Promore Pharma AB today announced that the company was granted a patent in Japan for the usage of LL-37 for treating chronic wounds.
FDA
Oncoceutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for ONC206, allowing the first-in-human trial of the compound. ONC206 is the first of the family of drug candidates, which we call “imipridones”, that possess the same core chemical structure as ONC201.
FDA
It takes on average five years before the confirmatory trial is even started.
According to “people familiar with the matter,” the company and its owners, the Sackler family, are plotting out a way to end the vast number of lawsuits filed against the company over its marketing practices for OxyContin and other opioid products.
Local Health Departments in Colorado, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Missouri, Nevada, New Hampshire, Ohio, Pennsylvania, Tennessee, and Wisconsin Tell Their Stories
Pharmaceutical manufacturing license and GMP compliance of the Rentschler Fill Solutions plant reconfirmed by the Austrian Agency for Health and Food Safety (AGES)
The Alliance for Regenerative Medicine released a Therapeutic Developers’ Statement of Principles, setting forth a bioethical framework for the use of gene editing in therapeutic applications.
AstraZeneca said the FDA awarded the designation to Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease.
Between J&J, Purdue ($270 million), and Israel-based Teva Pharmaceuticals ($85 million), Oklahoma will garner about $927 million – a far cry from the $20 billion the state had been seeking in damages related to the opioid crisis.
Adocia announced that the American Arbitration Association Tribunal governing Adocia’s arbitration claims against Eli Lilly & Company dismissed both parties’ claims in the second and final phase of the arbitration between Adocia and Lilly.