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…
Gilead and Bristol-Myers Squibb (BMS) are touting positive data from studies of their bespoke CAR-T cell treatments, each company hailing the results as a new treatment era for patients with…
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. Source: Drug Industry Daily
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…
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. Source: Drug Industry Daily
In a draft guidance released Friday, the FDA’s Center for Drug Evaluation and Research (CDER) offers advice for sponsors developing products for bowel cleansing prior to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…
In a 269-page report released Friday, the House Committee on Oversight and Reform challenges claims that high prescription drug prices are necessary to support innovation and details a slew of…
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…
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…
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. Source: Drug Industry…