| Back from the Dead: Biogen will submit aducanumab for FDA review in Alzheimer’s, months after phase 3 trials of the drug were terminated early by a data-monitoring committee. The drugmaker will instead press on with data from after the cutoff. “The result of the futility analysis was incorrect,” Biogen said, stunning analysts who couldn’t decide whether the move was a treat or a Halloween trick—but they agreed that what once was dubbed a “transformative failure” could completely remake Biogen if it’s approved. | |
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Featured Story | | | Tuesday, October 22, 2019 Biogen is planning to file for FDA approval of its failed Alzheimer’s disease drug aducanumab. The drug flunked a futility analysis in March, but Biogen resurrected it after factoring in data generated after the cutoff for the interim assessment. |
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Top Stories Of The Week Wednesday, October 23, 2019 Biogen stunned investors and analysts alike on Tuesday when it said it would file its Alzheimer's medaducanumab for approval, despite canning two phase 3 studies for the drug after a futility analysis. Now that the dust has settled, what are analysts saying? Monday, October 21, 2019 As the biopharma industry’s digital transformation continues apace, with the rapid acceptance of tools such as artificial intelligence and machine learning, certain projects promise to yield impacts on a much wider scale. Friday, October 18, 2019 Merck has struggled with certain diabetes and cardiovascular drugs, but its cancer business—including star checkpoint inhibitor Keytruda—is booming. Now, the company is chopping 500 jobs nationwide as part of a continued shift to focus more on innovative drugs. The company is cutting jobs in “select sales and headquarters commercial teams" effective Jan. 3. Monday, October 21, 2019 The triple combo era in cystic fibrosis is here, thanks to Vertex's new OK. Five months ahead of schedule, the FDA greenlighted Trikafta—the company's next big blockbuster hope—to treat CF patients over the age of 12 with a particular gene mutation. Monday, October 21, 2019 A pivotal trial of Seattle Genetics’ tucatinib in patients with HER2-positive breast cancer has met its primary endpoint. The data tee Seattle Genetics up to file for FDA approval of a TKI inhibitor it paid $614 million to acquire last year. Friday, October 18, 2019 Johnson & Johnson's talc woes deepened Friday after the FDA turned up "sub-trace" levels of asbestos in the company's baby powder, triggering a recall. J&J only pulled one lot of the product, but amid a high-profile legal fight, spooked investors headed for the exits, wiping billions off the drugmaker's market value. Monday, October 21, 2019 Smith & Nephew CEO Namal Nawana will step down after about a year and a half in the position over salary demands. Starting Nov. 1, Nawana will be replaced by the former CEO of Roche Diagnostics, Roland Diggelmann. Friday, October 18, 2019 Pfizer’s tafamidis franchise has been on a road paved with blockbuster hopes since its FDA nod in May. Now, one group of analysts says the drug’s early uptake has been faster than expected—and physicians tend to favor it over rivals by Alnylam and Ionis. Sunday, October 20, 2019 A team led by scientists at Scripps Research has found a possible way to more efficiently deliver genes to improve blood stem cell-based gene therapy treatment outcomes and reduce costs—and it involves using a close relative to a natural compound found in grapes. Tuesday, October 22, 2019 Sanofi is playing catch-up in gene therapy, but new CEO Paul Hudson is taking quick steps to close the gap. 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