A rule forcing the FDA and other agencies in the U.S. Department of Health and Human Services (HHS) to evaluate and clean out old regulations will never see the light of day.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Biomind, Clearmind, Cynata, Hyundai, Innocare, Janssen, Merck, Pfizer, Reata, Revive, Roche, Scisparc, Servier.
A lengthy trial over two generic drug manufacturers’ alleged role in fueling the opioid epidemic in West Virginia came to an end this week when the U.S. affiliate of Teva Pharmaceuticals Ltd. and Allergan, now part of Abbvie Inc., agreed to a settlement totaling more than $161.5 million.
Ignoring congressional sentiment, U.S. Health and Human Services Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health as an independent entity within the NIH.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Cornerstone, Elevation, Jaguar, Medac, Medexus, Oncotelic, Phathom, Verrica.
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpine, Antios, Assembly, Blue Lake, Ceruvia, CSL, Dermavant, ENB, Immune, Merck & Co., Neuronascent, Noveome, Ocugen, Roche, Synlogic, United, Xcovery.
An executive compensation consultant is facing both civil and criminal charges related to insider trading in advance of an acquisition announcement by one of his clients, Kadmon Holding Inc.
With drug shortages becoming a fact of life during the pandemic, the U.K.’s Medicines & Healthcare Products Regulatory Agency (MHRA) is issuing two guidances to help ensure access to essential medicines in Great Britain and Northern Ireland, especially during shortages and public health emergencies.
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