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Gary Kobinger, the leader of the Canadian research team that developed a highly effective Ebola vaccine, has stepped down from Canada’s COVID-19 vaccine task force, calling for greater transparency from the group. Read More
The FDA’s planned guidance on Emergency Use Authorization (EUA) of COVID-19 vaccines may be released as soon as this week and could include standards making an EUA unlikely before the Nov. 3 presidential election. Read More
The FDA cited Sun Pharma’s New Jersey-based subsidiary Ohm Laboratories for batch testing and other quality failures following an inspection. Read More
Merck said its blockbuster cancer drug Keytruda (pembrolizumab) doubled patients’ five-year survival rate compared to chemotherapy in a late-stage trial as a first-line treatment for metastatic nonsmall-cell lung cancer (NSCLC). Read More
The House of Representatives on Monday passed three bipartisan pharma bills, all by voice votes, aimed at promoting continuous drug manufacturing, the release of drugs from the Strategic National Stockpile and extending the FDA’s authority for counterfeit products. Read More
Prominent medical journal The Lancet has tightened its publishing requirements for research papers in response to an embarrassing retraction of a study based on questionable data from multiple trials. The journal said it will now require stronger data reviews for papers based on large, real-world datasets. Read More
AstraZeneca has released the trial protocols for the late-stage study of its coronavirus vaccine candidate, AZD1222, amid mounting calls for transparency as its investigation into an adverse event continues. Read More
HHS has clarified that last week’s memo from Secretary Alex Azar will in no way impact the FDA’s decisions on drugs and vaccines although former FDA officials say questions remain. Read More