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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Erleada is an androgen receptor inhibitor approved for non-metastatic castration-resistant prostate cancer.
Late Monday the federal government charged the husband and wife team of Yu Zhou, 49, and Li Chen, 46, with theft of scientific trade secrets from the hospital that focused on exosomes and exosome isolation.
MorphoSys AG announced that its licensee Janssen Research & Development, LLC issued a press release to report the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of Tremfya for the treatment of adult patients with active psoriatic arthritis.
Horizon Discovery Group plc announces its results for the six months ended 30 June 2019.
Law firm urges Zantac users to find out their rights against drug maker who knowingly sold potentially carcinogenic medication
Auris Medical Holding Ltd. announced that it has obtained advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen® from the U.S. Food and Drug Administration and from the European Medicines Agency.
Akari Therapeutics, Plc announced that the U.S. Food and Drug Administration has granted orphan drug designation for nomacopan for the treatment of bullous pemphigoid.
Days after reaching a tentative agreement with a majority of states involved in litigation against the company over its role in the opioid crisis in the United States, Purdue Pharmaceuticals filed Chapter 11 bankruptcy.
September has been a relatively slow month for the U.S. Food and Drug Administration. However, there are two PDFUA dates remaining, although one of those took an unexpected turn that will delay it until later in the year.
Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the United States, the company said.