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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
The FDA has approved Merck’s blockbuster cancer drug Keytruda (pembrolizumab) for certain patients with esophageal or gastroesophageal cancer taken in combination with platinum and fluoropyrimidine-based chemotherapy. Read More
In yet another setback for AstraZeneca, U.S. health officials raised concerns that the company included outdated information in its interim analysis of data from its U.S. phase 3 vaccine trial, prompting AZ to say it will release the results of its primary analysis by Thursday. Read More