Alzheimer milestones & vaccine politics: a BioCentury podcast
Alzheimer’s disease therapies continue to tease and torment biotech investors. In the latest BioCentury This Week podcast, BioCentury editors discuss the road ahead for Biogen’s closely watched therapy aducanumab and anti-tau therapies, whose most significant clinical readout to date disappointed. The editors also discuss the key takeaways from BioCentury’s interview with Operation Warp Speed co-leader Moncef Slaoui, who arguably has the best line of sight into the state of play for COVID-19 countermeasures of anyone in the world.
Selina Koch joins fellow Executive Editor Jeff Cranmer to discuss FDA’s announcement of an earlier than expected advisory panel meeting to discuss aducanumab to treat Alzheimer’s. Koch says the timing of the meeting suggests a decision on the anti-amyloid therapy could come earlier than its March 7 PDUFA date. While Cranmer argues that the approval is no slam dunk, Koch says that even if the therapy were approved Biogen Inc. (NASDAQ:BIIB) will have to overcome multiple market access hurdles to ensure a successful launch.
Koch also discusses how the string of disappointments in Alzheimer’s have now extended to tau, the next major target biopharma companies are backing, with the first anti-tau antibody to reach Phase II failing to slow cognitive decline. She wrote about the results from the semorinemab study by AC Immune S.A. (NASDAQ:ACIU) and Genentech Inc. in detail last week (see “The Road Ahead for Tau”).
Washington Editor Steve Usdin says Slaoui expects two COVID-19 vaccines and two therapies that reduce mortality from the disease will be authorized by year-end. He also discusses how Slaoui’s defended his integrity in response to Sen. Elizabeth Warren’s allegations of corruption. A transcript of the Q&A with the former pharma R&D head and chairman of vaccines at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) is available in front of BioCentury’s paywall (see “Warp Speed’s Slaoui”).
Usdin also weighs in on the impact comments by President Donald Trump on pending FDA COVID-19 guidance have had on the morale of FDA’s staff and the agency’s credibility (see “Trump Contradicts Hahn”).