The latest global regulatory news, changes and updates affecting biopharma, including: MOU to help with compounding oversight; MHRA advises on MA transition; CMS delays date for radiation oncology bundle; NRC issues advisory letter to INIS.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Astrazeneca, Evgen, Kezar.
Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Adicet, F2G, Gilead, Leo, Nevakar, Reven.
To end criminal and civil claims stemming from its marketing of Oxycontin (oxycodone hydrochloride) and other opioid products, Purdue Pharma LP agreed Oct. 21 to pay more than $8 billion and to cease operating as a for-profit private company – provided the court presiding over its bankruptcy agrees.
With a Nov. 6 FDA adcom meeting on Biogen Inc.'s Alzheimer's candidate, aducanumab, creeping ever closer, the candidate's prospects stole the show in its third-quarter earnings report, even outshining attention to the cloud of generics raining on the company's years-long Tecfidera (dimethyl fumarate) parade. FDA acceptance for aducanumab's BLA lines the candidate up for a priority review and regulatory action by March 7, the company said. Furthermore, global progress remains underway, with an EU marketing application now made and one in Japan on deck.
While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Ascentage, Cyclo, Diurnal, Effrx, Hillstream, Pharming, Protagonist, PTC, Roche, TG, Xeris, Zosano.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amacathera, Asklepios, Astrazeneca, Inventiva, Selecta.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Agios, Astrazeneca, Bristol Myers Squibb, Dr. Reddy's, Edesa, Exelixis, Genentech, Gilead, Intellia, Matinas, Mereo, Neurelis, Octapharma, Oncopeptides, Prestige, Recce, Roche, Versantis.
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