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Johnson & Johnson subsidiary Janssen has agreed to pay up to $780 million for the global rights to Cidara Therapeutics’ Cloudbreak antiviral conjugate (AVC) candidates being developed for preventing and treating seasonal and pandemic influenza. Read More
Moderna has expanded its existing agreement with Catalent to boost COVID-19 vaccine production at Catalent’s fill-and-finish facility in Bloomington, Ind., to supply the U.S. market. Read More
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