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The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a temporary policy guidance addressing the COVID-19-related shortage of Roche’s blockbuster immunosuppressive tocilizumab, which the FDA requires to be on hand during infusions of chimeric antigen receptor (CAR-T) cell immunotherapies as cancer treatments. Read More
A federal judge has issued an injunction temporarily halting a California law outlawing “pay-for-delay” agreements between branded drug manufacturers and makers of generics. Read More
The Senate Finance Committee has released amended Build Back Better Act text, which would exempt generics and biosimilars at risk of supply chain shortages from rebates drugmakers would have to pay to the government if they raise prices faster than the annual rate of inflation. Read More
Pfizer announced that it will buy Park City, Utah-based Arena Pharmaceuticals for $6.7 billion, pumping up its portfolio of therapies for immuno-inflammatory diseases. Read More
In a final guidance released Friday, the FDA adopted International Council for Harmonization (ICH) guidelines for three solvents used in drug manufacturing processes, based on the most up-to-date data on reproductive, genetic and carcinogenic toxicities. Read More
In a draft guidance released Friday, the FDA’s Center for Drug Evaluation and Research (CDER) offers advice for sponsors developing products for bowel cleansing prior to colonoscopy, suggesting the necessary attributes of patients for enrollment in clinical trials. Read More
Johnson & Johnson (J&J) has appointed new members to its executive committee ahead of splitting its pharmaceuticals and over-the-counter consumer products businesses within the next two years. Read More
Moderna says its messenger RNA flu vaccine candidate, mRNA-1010, successfully boosted titers against all four influenza strains it’s being tested against during an ongoing phase 1 study, even at lowest dose, and that no significant safety concerns were observed. Read More