WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST According to an online quiz from Biogen and Eisai, if you occasionally forget an appointment, lose your train of thought, or feel overwhelmed in the face of a decision, those could be the early signs of Alzheimer’s. But even if you say those never happen to you, the site will still prompt you to talk to a doctor about cognitive screening, and even PET scans—which critics describe as a predatory move to promote its controversial, $56,000-a-year Aduhelm treatment. Meanwhile, AbbVie shared full results from a medicine for farsightedness that comes with age, which is typically treated with contacts or glasses, showing significant vision improvements after 30 days. Those stories, plus our top reads of the week, follow below. | |
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Featured Story | By Nick Paul Taylor AbbVie has shared full results from a phase 3 trial it is hoping will persuade the FDA to approve a medicine solution for age-related far-sightedness, which is typically treated with contacts or glasses. The study of AGN-190584 showed significant improvements in the vision of patients with age-related far-sightedness after 30 days of dosing. read more |
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Top Stories Of The Week By Noah Higgins-Dunn Biogen's latest marketing push focusing on early Alzheimer's detection—just weeks after the FDA narrowed Aduhelm's label—is rousing criticism among some experts who say the company is trying to cause undue concerns over mild cognitive impairment. However, some acknowledge that diagnosing cognitive impairment early on isn't easy. read more By Kyle LaHucik,Annalee Armstrong Annovis Bio wants its therapy to be better than Biogen's Aduhelm, but the latest data shows the drug did not improve dementia symptoms, problem-solving, orientation or judgment, among other data points. The company revealed a mixed—and confusing—bag of results from a small phase 2a study Wednesday night at the 2021 Alzheimer's Association International Conference in Denver. read more By Angus Liu GlaxoSmithKline has picked a familiar face to lead its consumer health business after a planned spinoff next year. Hint: It’s not group CEO Emma Walmsley as activist investor Elliott Management may have wished for. read more By Noah Higgins-Dunn Johnson & Johnson’s COVID-19 vaccine presents greater benefits than it does safety risks, especially amid the quickly spreading Delta variant, a key CDC expert panel decided. However, the panel said that a ruling over the need for a booster added to all COVID shots will have to start with the FDA. read more By Andrea Park A recall of Philips’ ventilators for at-home and clinical use was given the FDA’s most serious classification after the devices were found to put users at risk of inhaling or swallowing dangerous pieces of debris. read more By Ben Adams Just two months after getting a swift approval for its closely watched KRAS lung cancer drug Lumakras, Amgen is not resting on its laurels and has penned a major new buyout deal to further boost its oncology pipeline. read more By Fraiser Kansteiner Moderna will delay some overseas vaccine shipments after its ex-U.S. production partners were hit with manufacturing lab issues, a company spokesperson said. Separately, 51 million Novavax doses bound for Australia in the back half of the year are now expected to ship in 2022, The Guardian reports. read more By Kyle LaHucik Less than two months after Biogen received the FDA green light for its controversial Alzheimer's drug Aduhelm, competitor Prothena said preclinical studies of its own monoclonal antibody targeting amyloid-beta show that the drug binds to its target with about 11 times more strength than Biogen's does. read more By Fraiser Kansteiner Takeda is injecting $126 million into its Thousand Oaks facility to boost manufacturing and support new product lines. read more Resources Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: Blue Matter Consulting E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic. Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: PA Consulting What does the future of Cell & Gene Therapy look like? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. | 