U.S. federal authorities have made a lot of noise over inappropriate medical testing in the past two years, largely due to the COVID-19 pandemic, but Paul Garcia, a partner in the San Diego office of Hooper, Lundy & Bookman PC, says this trend will not ebb at all in the coming year. Garcia told BioWorld that the lookback period for Medicare testing claims runs several years and that not only will enforcement results continue to surface next year, but also that the associated civil monetary penalties could force a testing lab to shutter its operations permanently.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Angiocrine, Arrowhead, Carrick, Catalyst, Eisai, Menarini, Merck, Paratek, Pfizer, Royalty.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alexbio, Amicus, Apellis, Boehringer Ingelheim, CSL Behring, Eli Lilly, Jacobio, Miromatrix, Moderna, Ocugen, Roche, Regeneron, Sanofi, Uniqure, Y-Mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aelis, Astellas, Bioved, Cerevel, Equillium, Krystal, Mimivax, Ocugen, Palisade, Skye, Synaptogenix.
One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.
Everest Medicines Ltd. has achieved a preclinical proof-of-concept milestone for its mRNA rabies vaccine program. This new vaccine candidate for rabies post-exposure prophylaxis was developed in partnership with Providence Therapeutics Holdings Inc. utilizing a clinically validated mRNA technology platform.