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A new report analyzing drug research and development (R&D) during the pandemic found that while cancer drugs have remained industry’s top focus, anti-infective drugs saw the biggest increase of all therapies due to the monumental efforts to combat the COVID-19 crisis. Read More
Johnson & Johnson (J&J) said it expects to deliver 20 million doses of its COVID-19 vaccine for the U.S. by the end of March, as officials nationwide continued to complain of severely limited supplies of the single-shot vaccine. Read More
AbbVie has filed a lawsuit alleging that Iceland-based biosimilar developer Alvotech recruited a former AbbVie employee to steal trade secrets in order to produce a biosimilar of AbbVie’s blockbuster arthritis drug Humira (adalimumab). Read More
As Europe continues to face challenges and setbacks in its COVID-19 vaccination efforts, the European Commission (EC) has proposed new criteria for vaccine export authorizations to conserve its supplies. Read More
Pfizer is conducting a U.S. phase 1 trial of an oral COVID-19 antiviral, PF-07321332, a protease inhibitor that can stop the virus from replicating. An oral drug would be much easier to administer than an intravenous formulation — a significant advantage during the pandemic. Read More
The Pfizer/BioNTech COVID-19 vaccine has only limited efficacy against the variant SARS-CoV-2 strain first identified in South Africa, a new study from Israel suggests. Read More
Democrats are reportedly considering using budget reconciliation, a procedure that would allow them to bypass Republican opposition and filibustering, to get major drug pricing legislation to the president’s desk. Read More
Amy Abernethy, the FDA’s principal deputy commissioner and acting chief information officer, will depart from the agency in a matter of weeks, according to acting commissioner Janet Woodcock. Read More
The Center for Drug Evaluation and Research (CDER) highlights efforts to deal with drug shortages, sham COVID-19 products and poorly compounded drugs, as well as its enforcement successes amidst the pandemic, in its latest annual report from its Office of Compliance, released yesterday. Read More