Archive for January 2022

The FDA has approved Roche’s Vabysmo (faricimab-svoa) for treating the two most common forms of vision loss, paving the way for the drug to go head-to-head with Regeneron Pharmaceuticals’ blockbuster, Eylea (aflibercept). Source: Drug Industry Daily

Madrigal Pharmaceutical’s investigational drug resmetirom reduced liver fat by up to 48 percent over one year, raising hopes of a first-in-class approval for nonalcoholic steatohepatitis (NASH), company executives said yesterday. Source: Drug Industry Daily

Chinese authorities have arrested AstraZeneca China employees who are accused of tampering with gene-testing results of tumor patients in order to fraudulently claim reimbursement from national health care insurance funds. Source: Drug Industry Daily

The FDA explains how combination products are assigned for review within the agency in a newly released final guidance. Source: Drug Industry Daily

Deadlines are approaching for drugmakers to file their CARES Act Amount Information report, detailing the amount of listed drugs and biological products they’ve produced and sold over the year. Source: Drug Industry Daily

A new consolidated, online clinical trials database that becomes active today in Europe will allow drug sponsors in the EU to run clinical trials in all 27 member states with a single documentation filing. Source: Drug Industry Daily

The European Medicines Agency’s (EMA) human medicines committee endorsed seven drugs for new indications during its monthly meeting last week, including Pfizer’s highly effective COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir). Source: Drug Industry Daily

Regeneron Pharmaceuticals and Sanofi are pulling their supplemental Biologics License Application (sBLA) for the indication of cervical cancer for their human monoclonal antibody, Libtayo (cemiplimab-rwlc). Source: Drug Industry Daily

The U.S. International Trade Commission (ITC) will investigate whether Alvotech and its partner Teva Pharmaceuticals misappropriated trade secrets in producing a biosimilar candidate for AbbVie’s autoimmune mega-blockbuster Humira (adalimumab). Source: Drug Industry Daily

Eli Lilly has given up on its blockbuster rheumatoid arthritis drug Olumiant as a treatment for lupus. Source: Drug Industry Daily