Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Cara, CNS, Janssen, Jasper, Moderna, Mycovia, Nevakar, SQZ, Timber, Vifor, Xbiotech.
Bristol Myers Squibb Co.’s audacious $13.1 billion 2020 takeover of Myokardia Inc. appears to have paid off with U.S. FDA approval of the drug at the heart of the deal, mavacamten. The medicine, a cardiac myosin inhibitor for treating adults with obstructive hypertrophic cardiomyopathy (HCM), will be marketed under the brand name Camzyos.
Eli Lilly and Co.'s tirzepatide, a high-profile entrant in the global anti-obesity race, hit a key milestone, becoming the first investigational medicine to deliver more than 20% weight loss on average for non-diabetics in a phase III study, said Jeff Emmick, vice president of product development at the company.
Mycovia Pharmaceuticals Inc. is prepping to launch its first commercial product following U.S. FDA approval of oral antifungal oteseconazole for use in recurrent vulvovaginal candidiasis (RVVC). Branded Vivjoa, the drug is expected to be available to patients during the second quarter.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nano-X, Nocira, Onera, Transmedics.
Making his first in-person appearance April 27 before the House Energy and Commerce Subcommittee on Health, U.S. Health and Human Services Secretary Xavier Becerra was prepared to answer questions about President Joe Biden’s fiscal 2023 budget that would increase HHS’ discretionary budget to $127 billion, nearly a 27% increase over the 2021 enacted level.
Within just a few hours, Molecular Partners AG reported both a potential snag in securing emergency use authorization (EUA) for its Darpin antiviral, ensovibep, and the loss of a half-billion-dollar partnership with Amgen Inc. for the phase I-stage 4-1BB-targeting compound MP-0310. While neither update is likely to dampen prospects for the company’s overall Darpin pipeline, the near-term investor disappointment was enough to send shares (NASDAQ:MOLN) closing 37% lower April 27, after dropping to their lowest point since the Zurich, Switzerland-based firm priced its $63.8 million IPO on Nasdaq in June 2021.
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