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In its latest annual report on Drug Safety Priorities released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) noted that much of its focus in 2021 remained on pandemic-related products. Read More
The National Institutes of Health (NIH) will decide this month whether Pfizer’s patent on Xtandi (enzalutamide), a prostate cancer drug’s that’s five times pricier in the U.S. than it is in other countries, is subject to so-called “march-in rights.” Read More
Chinese authorities have arrested AstraZeneca China employees who are accused of tampering with gene-testing results of tumor patients in order to fraudulently claim reimbursement from national health care insurance funds. Read More
Deadlines are approaching for drugmakers to file their CARES Act Amount Information report, detailing the amount of listed drugs and biological products they’ve produced and sold over the year. Read More
The UK is providing booster doses to up to 1 million people every day, while “more than 3 billion people across the world have yet to receive their first dose,” the letter said. Read More
A new consolidated, online clinical trials database that becomes active today in Europe will allow drug sponsors in the EU to run clinical trials in all 27 member states with a single documentation filing. Read More
Michigan’s Attorney General is pursuing court approval to begin an investigation into Eli Lilly over the high insulin prices the company charges. Read More