To disrupt the high-cost insulin market, the state of California is teaming up with nonprofit generic drug manufacturer Civica Rx to make insulins that will become available at low cost. Read More

CDER’s Office of Compliance issued 101 warning letters in fiscal 2022 — about two-thirds of them related to COVID-19 products, according to the office’s latest annual report. Read More

BioNTech and OncoC4 have inked a deal that has BioNTech paying $200 million upfront to co-develop and commercialize OncoC4’s anti-CTLA-4 monoclonal antibody candidate as a monotherapy or combination therapy for various cancers. Read More

Karuna Therapeutics touted another phase 3 success with its novel schizophrenia therapeutic, KarXT(xanomeline/trospium). Read More

Johnson and Johnson (J&J) and Janssen Biotech have agreed to pay $25 million to settle a class action lawsuit alleging they violated antitrust laws in marketing their blockbuster drug anti-inflammatory drug Remicade (infliximab). Read More

The years-long pressure campaign from the U.S. government to get insulin makers to drop their prices has worked — to some extent. Read More

The FDA outlined its current thinking on submitting pharmacogenomic data in new drug applications in a draft guidance released Friday. Read More