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A Moderna or Pfizer/BioNTech COVID-19 booster dose was found to give highly effective protection against the Delta and Omicron variants, the Centers of Disease Control and Prevention (CDC) said Friday. Read More
Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through fiscal year 2020 to fiscal year 2021, according to the latest data posted on the agency’s “dashboard” — which tracks how well the agency is living up to its review commitments under the user fee programs. Read More
The developers will not receive any royalties on sales for as long as the World Health Organization considers COVID-19 a public health emergency. Read More
The next FDA commissioner — most likely Robert Califf, who is now awaiting a confirmation vote by the Senate — will face a tough 2022 on multiple fronts, beyond just dealing with the ongoing pandemic and drug supply-chain shortages. Read More
The European Parliament has endorsed a plan to strengthen the powers of the European Medicines Agency (EMA) to increase monitoring of the supply chain for drugs and medical devices. Read More
In oral arguments held Wednesday, Sanofi urged a federal appeals court to reconsider its complaint against Mylan (now Viatris) over allegations the latter engaged in anticompetitive practices to maintain its EpiPen monopoly. Read More
The FDA has extended its delay on conducting in-person domestic surveillance inspections through Feb. 4 with the goal of restarting the activities as soon as safely possible. Read More
Thanks to a recent legal win for Merck, companies may have an easier time getting insurance coverage for damage incurred from nation-state-backed malware attacks. Read More