Regulation

FDA finally approves ozanimod for MS, satisfying first criterion for Bristol-Celgene CVR; launch delayed due to COVID-19

FDA’s approval of Celgene’s multiple sclerosis drug Zeposia ozanimod represents the first domino to fall among three that could lead to a big payout for Celgene’s former shareholders, who would be owed a contingent value...

China’s NMPA suspends Abraxane imports after U.S. inspection

China’s suspension of the importation and sale of Celgene’s Abraxane by BeiGene following an inspection at a U.S. manufacturing site demonstrates how far the country has come in its drive to ensure safety of drugs,...

Reversing course, Gilead asks FDA to rescind remdesivir's Orphan designation

Two days after receiving Orphan Drug designation for its COVID-19 therapeutic, Gilead has asked FDA to rescind the status and said it would waive “all benefits that accompany the designation.” “Gilead is confident that it...

Global regulators’ report offers framework for data needed to move COVID-19 vaccines into clinic

An international report released Tuesday provides a framework for what data COVID-19 vaccine developers should gather before moving into first-in-human studies. The coalition emphasized the need for preclinical data to address the potential of a...

FDA facilitating compassionate use of convalescent plasma for COVID-19

FDA Tuesday released guidance to help physicians provide convalescent plasma to COVID-19 patients on a compassionate use basis, outside of a clinical trial. The presidents of the U.S. National Academy of Sciences, National Academy of...

FDA easing some REMS requirements during pandemic

Taking into consideration how social distancing and shelter in place edicts may make it difficult for patients to visit a lab, FDA released guidance Monday easing Risk Evaluation and Mitigation Strategy requirements. If a drug’s...

FDA authorizes first COVID-19 point-of-care diagnostic

FDA granted Emergency Use Authorization to Cepheid’s Xpert Xpress SARS-CoV-2 test, the first point-of-care diagnostic for COVID-19. The approval of the test, which can be run in 45 minutes, is FDA’s latest step to ramp...

Like FDA, EMA prioritizes patient safety and data integrity in clinical trials amid outbreak

Days after FDA outlined its thinking on adjustments to planned and ongoing clinical trials during the COVID-19 outbreak, EMA has followed suit with guidance that echoes many of the U.S. regulator's recommendations. Like FDA's guidance,...

COVID-19: A guide to regulatory meeting cancellations, new dates and virtual options

As the list of regulatory meetings affected by the COVID-19 outbreak grows, BioCentury is tracking the latest cancellations, reschedulings and options to attend virtually. The list will be updated on an ongoing basis. Table: Table:...

FDA’s clinical trial guidance stresses patient safety, studies’ integrity amid outbreak

As disruptions begin to mount among biopharmas’ planned or ongoing clinical trials during the COVID-19 outbreak, newly issued FDA guidance clarified the agency’s thinking on how sponsors can ensure participants’ safety and implement modifications to...

As EMA shifts to virtual meetings, agency doesn’t expect impact on drug assessments, safety monitoring

EMA says its assessment and monitoring of medicines hasn’t been affected by the COVID-19 pandemic, even as the agency transitions to virtual meetings. The agency said Wednesday that all meetings of committees, working parties and...

FDA postpones meetings and inspections, grounds staff to combat COVID-19

FDA is postponing meetings, cancelling most travel and halting most foreign inspections as part of U.S. government-wide steps to contain the COVID-19 outbreak. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER),...

Intarcia’s path uncertain after second regulatory stumble for diabetes implant

Massive fund-raising over the past decade positioned Intarcia to enter the market with ITCA 650, a matchstick-sized implant that delivers a GLP-1R agonist to Type II diabetes patients subcutaneously for six months. But now that...

FDA dropping CVOT requirement for diabetes drugs

Editor’s note: This story has been updated to reflect details contained in FDA’s guidance. Twelve years after FDA issued draft guidance that made it exorbitantly expensive to bring a new diabetes therapy to market, the...

Shanghai exchange rebukes BrightGene for statements on remdesivir

BrightGene shares tumbled as the Shanghai exchange reprimanded the company for misstatements regarding its production of antiviral candidate remdesivir from Gilead. In a statement Sunday, the exchange reported the results of its investigation into a...