Sponsors of cancer drugs can apply for real-time review of their trial data if their investigational products demonstrate substantial improvements over available therapy and use straightforward study designs and endpoints…

Biogen is writing off $275 million worth of Aduhelm (aducanumab) inventory — a formal declaration that the Alzheimer’s drug has no market value at all. Source: Drug Industry Daily

The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Source: Drug…

It’s looking more and more likely that Congress will miss its deadline to pass a user-fee reauthorization bill — potentially forcing the agency into sending out furlough notices to its…

The FDA issued a proposed rule on Friday that would require drugmakers to use a standardized 12-digit National Drug Code (NDC) format with three distinct segments. Source: Drug Industry Daily

In a pair of final guidances published Friday, the FDA outlined acceptable reasons for requesting an extension for responding to a Complete Response Letter (CRL) and provided answers to frequently…

Countries participating in this year’s Pangea XV, an international illicit drug crackdown, made more than 7,800 seizures of illicit and misbranded medicines worth $11 million and totaling 3 million individual…

The European Medicines Agency is calling for public comment on the International Council for Harmonization (ICH) new draft guidance on conducting drug interaction studies. Source: Drug Industry Daily

Novartis no longer plans to submit PD-1 checkpoint inhibitor tislelizumab for approval in the U.S. as a monotherapy for nonsmall-cell lung cancer (NSCLC). Source: Drug Industry Daily

In a worrying sign for several drug candidates, Roche said it has halted five phase 1 and 2 trials evaluating therapies for major diseases including cancers, asthma and a metabolic…