Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gynesonics, Neovasc, Thermo Fisher.
As members of the White House COVID-19 Response Team talk about COVID-19 boosters as if they are a fait accompli for Americans even before the FDA completes its evaluation of the data, the controversy continues to roil around the need for another vaccine dose.
A new law in China will grant physicians the right to use off-label drugs, giving clearer definition to a gray area and lending hope that it could benefit pharma companies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Amylyx, Aptorum, Beigene, Calliditas, Cstone, Excision, Jaguar Health, Magenta, Obseva, Pulmocide, Sage, T-Cure, Zai Lab.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
The new regulatory framework for the EU is now in force, and it touches on the respective roles of manufacturers, distributors and other economic operators (EOs). Erik Vollebregt, of Axon Lawyers in Amsterdam, told an audience at the 2021 Regulatory Convergence sessions that the roles and responsibilities of these EOs are frequently misunderstood, a predicament that amplifies the regulatory and legal risk for all these entities doing business in the EU.
The U.S. Centers for Medicare & Medicaid Services (CMS) has withdrawn the rule for the Medicare Coverage of Innovative Technologies (MCIT) program, an action that predates the agency’s self-imposed deadline of December 2021 by three months. The agency cited some previously discussed issues with the rule, but the move was blasted by industry as thwarting the support of the majority of stakeholders.
The Biden administration’s haste to roll out an eight-month COVID-19 vaccine booster program next week is bumping up against the reality of the data and the regulatory process.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Axsome, BMS, Harbour, Isa, Kalvista, Neurogene, Pharmamar, Telix.
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