Nearly 18% of clinical data reported in August were focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May.
Special purpose acquisition companies (SPACs) have been making headlines recently in the life sciences, but these entities practice a business model that leaves some observers uneasy. Gary Gensler, chairman of the U.S. Securities and Exchange Commission (SEC), told a Senate committee recently that the risks to investors in SPACs has prompted him to ask his staff to come up with some proposals to increase transparency to investors, potentially leading to additional compliance costs for these entities.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amivas, Biocryst, Calliditas, Camurus, Cour, GSK, Golden, NFL, Pfizer, Stada, Takeda.
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.
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