The latest global regulatory news, changes and updates affecting biopharma, including: FDA weighing Xeljanz safety results; EMA initiates OPEN collaboration; NICE evaluating guidance processes; TGA seeking comments; USPTO extends program with Japan’s, Korea’s patent offices; NICE recommends Keytruda in NSCLC; Florida researcher indicted.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamas, Amgen, Applied, Argenx, Biogen, Janssen, Jeil, Merck, Mirum, Rockwell, Vyne, Zosano.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aruvant, Asana, Biocryst, Innovent, Prothena, RDIF.
HONG KONG – Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted approval for Biocryst Pharmaceuticals Inc.’s Orladeyo (berotralstat), the first and only drug for prophylactic treatment of hereditary angioedema (HAE) approved in the country. Biocryst’ partner, Torii Pharmaceutical Co. Ltd., will launch the drug after completing pricing negotiations with the Japanese National Health Insurance System (NHI). Tokyo-based Orphanpacific Inc., Biocryst’s representative in Japan, holds the marketing authorization.
The latest global regulatory news, changes and updates affecting biopharma, including: Researcher gets prison time for trade secret theft; USPTO responds to COVID-19 challenge.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, BMS, Cerecor, Chinook, Durect, Kintor, Mustang, Neurmedix, Paxmedica, Russian Direct Investment Fund, Sesen, SQZ, VBI Vaccines.
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.
The Medicare Part D rebate rule finalized by the Trump administration last November could be in limbo for a while. As it did with other so-called midnight rules issued in the waning days of the Trump presidency, the U.S. Department of Health and Human Services, under the Biden administration, is postponing the implementation of the rule, which was intended to simplify the U.S. drug pricing system by eliminating the rebates drug makers pay to pharmacy benefit managers for formulary placement or requiring plans to pass the discounts directly to patients.
The latest global regulatory news, changes and updates affecting biopharma, including: Veterans’ genomic data put at risk; DNA sequencing claims struck down; More BREXIT guidance.
Triggering a wave of commentary over its import, Biogen Inc. on Jan. 29 said the FDA has extended to June 7 its review of a BLA for the experimental Alzheimer's disease therapy aducanumab after the company submitted additional analyses and clinical data, making for a major amendment to the application. The three-month delay, from an earlier assigned PDUFA date of March 7, followed a thumbs-down vote by agency advisors in November. It sparked both sunny optimism and a bit of pessimism about the program's prospects on Friday.
RSS
