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The University of Oxford said it has paused a trial evaluating its COVID-19 vaccine co-developed with AstraZeneca in children and teenagers while it awaits additional information on the risk of blood clots from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Read More
The U.S. Army this week began phase 1 testing of a COVID-19 vaccine it developed, which is aimed at protecting against many coronavirus variants. Read More
In an effort to fund his massive $2 trillion plan to overhaul U.S. infrastructure, President Biden is proposing to come down hard on corporations with heavier taxes — and his tax strategy includes provisions to eliminate current overseas tax breaks and havens that would have a significant impact on the pharma industry. Read More
In public comments, industry trade associations have largely welcomed the FDA’s efforts thus far to improve its process for reviewing and approving biosimilars under the Biosimilar User Fee Amendments (BsUFA) II program. Read More
The FDA has issued a Complete Response Letter (CRL) to San Diego, Calif.-based Acadia Pharmaceuticals for their supplemental New Drug Application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). Read More
The FDA released Q&A guidance yesterday on bioequivalence (BE) studies for generic drugs and abbreviated new drug application (ANDA) submissions during the COVID-19 pandemic. Read More
The U.S. government has stepped in to address a serious manufacturing error at Emergent BioSolutions’ Baltimore, Md., facility that wasted 15 million Johnson & Johnson (J&J) vaccine doses. However, putting J&J in charge of the site and barring production of AstraZeneca (AZ)’s vaccine there isn’t likely to halt AZ’s production schedule, a White House official said Monday. Read More
The FDA has identified five main activities it will focus on for improving its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), including two on its reviews of Emergency Use Authorization (EUA) processes and its approaches to inspections, public communications and supply-chain monitoring. Read More