The U.S. International Trade Commission (USITC) is launching an investigation into the importation from China of certain thyroid hormone receptor-beta agonists, products containing them and the manufacturing processes being used.
A federal court cut off efforts Feb. 6 to halt a U.S. program allowing prescription drug imports from Canada before the program gets off the ground. The U.S. District Court for the District of Columbia dismissed a suit by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other organizations, saying that they lacked standing because neither they nor their members face “a concrete risk of harm from the inchoate importation program.”
While the new inflation-based rebate on certain Part B drugs may generate billions of dollars in savings for Medicare, implementing the rebate could be more challenging than the U.S. Congress and the Biden administration expected when the Inflation Reduction Act was enacted last August.
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.
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