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 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.
South Korea’s Ministry of Health and Welfare (MHW) is currently discussing the implementation of a preferential drug pricing system and plans to initiate an expert survey in 2022. The preferential drug pricing system is part of a three-prong strategy that South Korea plans to adopt to promote the growth of eight leading companies in the pharmaceutical, medical device and cosmetic industries by 2030.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
LONDON – The U.K. government has accepted the recommendation of medical experts and will begin the rollout of COVID-19 boosters from next week, using mRNA vaccines only. That follows data from the U.K. Cov-Boost trial, looking at combinations of initial and booster doses. The results showed Pfizer Inc./Biontech SE’s and Moderna Inc.’s products generated the best immune responses, regardless of which vaccine was administered initially.
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