The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit agrees Amgen patents lack enablement; HC nudging along with regulatory modernization plan; EMA: No Sputnik application yet.
The latest global regulatory news, changes and updates affecting biopharma, including: HHS posts rule for agency enforcement action; Guidance to help with COVID-19 Mabs; Chinese pharma exec sentenced on U.S. drug charges.
As expected, pharmacy benefit managers are challenging a final rule that would end Medicare’s antitrust safe harbor for the rebates drug companies pay to the PBMs for formulary placement.
Biond Biologics Ltd. co-founder and CEO Tehila Ben-Moshe told BioWorld that “a relatively small group of scientists who are very motivated started with a very basic scientific idea, which we were able to take all the way into clinical trials in four years,” and draw the interest of Paris-based Sanofi SA in a checkpoint inhibitor with multi-cell effects. In its second major deal of the week, Sanofi is pledging $125 million up front and more than $1 billion more in potential development, regulatory and sales-related milestone payments to Biond, of Misgav, Israel.
Despite a circuit split on the issue, the U.S. Supreme Court Dec. 11 rejected an appeal by Bristol Myers Squibb Co. (BMS) and Sanofi SA over giving states a “second bite at the apple” in whistleblower cases.
DUBLIN – Sanofi SA is paying $1.1 billion up front and up to $350 million more in potential clinical development and regulatory milestones to acquire antibody developer Kymab Ltd. The deal adds to Sanofi’s pipeline first-in-class OX40-ligand blocker KY-1005, which recently hit the primary endpoints of a phase IIa trial in atopic dermatitis, as well as a second clinical-stage asset, KY-1044, an ICOS agonist in development for solid tumors. It also brings Sanofi a new antibody discovery platform, comprising several transgenic mouse strains, which collectively encode all the building blocks required to produce fully human antibodies.
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival.
The U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. But the opinion said nothing about enforcement action or assessing civil penalties against manufacturers who refuse to do so.
The Sanofi SA-Glaxosmithkline plc COVID-19 vaccine program is taking a step backward to recalibrate as weak interim phase I/II data showed an insufficient response in patients age 50 and older. The step is a large one, delaying a potential launch until mid-2021 at the earliest and the end of next year at the latest.
The latest global regulatory news, changes and updates affecting biopharma, including: The other shoe drops for former Insys CEO; NICE gives nod to new myeloma regimen; MHRA prepares for January; FDA guidances finalized.
