Novartis AG’s FDA go-ahead for Leqvio (inclisiran), the first and only small interfering RNA therapy to lower LDL-C, “should come as a relief, given fears that the pandemic could again limit FDA's ability to conduct manufacturing-site inspections,” Jefferies analyst Peter Welford said. PCSK9-targeting Leqvio’s Dec. 22 approval, which came slightly ahead of the Jan. 1, 2022, PDUFA date, landed after a complete response letter about a year ago, citing unresolved facility inspection-related conditions. The drug is dosed twice per year, unlike competitors in the space.
Device makers have been making use of computational modeling and simulation (CMS) for device design for a number of years, and the FDA has released a draft guidance for how agency reviewers will assess the credibility of those models. However, the agency said there is a paucity of analytical methods for evaluating these tools, a factor that may add drag to the agency’s review of industry’s use of products and data thus developed.
The FDA has posted two draft guidances for the transition of policies from the pandemic to more normal times. One of these is the long-awaited draft for transitioning a device from an emergency use authorization (EUA) to a conventional premarket status, which offers a 180-day grace period for an EUA after the agency identifies a date on which the EUA will be terminated.
A U.S. federal jury convicted Charles Lieber, the former chair of Harvard University’s chemistry and chemical biology department, on charges related to lying to federal authorities about his affiliation with China’s Thousand Talents Plan and the Wuhan University of Technology (WUT), as well as failing to report the income he received from the institute.
With Omicron spreading rapidly, U.S. COVID-19 vaccine producers are facing increasing pressure to up their production and to do more to ensure their vaccines are accessible globally.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta, Phillips, Sight Sciences.
The EU is on its way to becoming one of the first to implement a historic global tax reform agreement, setting a minimum effective tax rate of 15% for large multinational groups, including biopharma and med-tech companies.
Antengene Corp. Ltd. received marketing approval from China’s NMPA for ATG-010 (selinexor), a drug that was in-licensed from Karyopharm Therapeutics Inc. It was approved for use in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma, specifically those who have received prior therapies and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
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