Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Awakn, Astrazeneca, CSL Vifor, FSD, Kiora, Optimi, Pharmather, Rocket.
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Biogen, Bioxytran, Egret, Endogena, Gilead, Hinova, Inmagene, Neogap, Neurosense, Sage, Sandoz, Takeda.
The U.S. Government Accountability Office (GAO) has sounded off again about the ability of other federal government agencies to respond to future crises and pandemics, arguing that the Department of Health and Human Services (HHS) has not forged a comprehensive assessment mechanism to account for the associated medical countermeasure production needs. However, GAO also remarked that HHS does not have a dedicated funding mechanism to finance these activities, a resource that might not become available until after HHS officials draft a budget for the activities associated with such efforts for congressional review.
In preparing for their showdown before the U.S. Supreme Court March 27 on what it takes to enable broad genus claims, both Sanofi SA and Amgen Inc. are warning that future innovation will be at stake if the court accepts the other company’s position.
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D, Gracell, Maat, Octapharma, Orexo, Pharmala, Psycheceutical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Calliditas, GSK, Pfizer, Pharmather, Pliant, Y-mabs.
Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established.
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
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