WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST What was going through the minds—and inboxes—of FDA officials as the COVID-19 pandemic unfolded? Hundreds of emails released by the agency offer a glimpse, with communications between task force members as well as biopharma execs on the roll out of remdesivir, hydroxychloroquine, diagnostic tests and more. Fast forward to now, where Pfizer and Moderna’s vaccines have shown responses against variants in a small study, and CytoDyn’s share price has plummeted after a rebuke by the FDA for cherry-picking data for its COVID treatment. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Beth Snyder Bulik What was going through the minds of the FDA officials during the earliest days of the COVID-19 pandemic? Thanks to hundreds of emails released by the FDA on Thursday—forced through the Freedom of Information Act—enquiring minds can find out. It's still just a glimpse, however, as quite a bit of the text copy, subject lines and emails are blacked out for confidentially reasons. read more |
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Top Stories Of The Week By Annalee Armstrong Biogen revealed that a gene therapy failed to improve vision in patients with X-linked retinitis pigmentosa, a disease area that has become ripe for the company’s rivals. The company had hoped the gene therapy would become a one-time treatment for these patients, who currently have no other treatment options. read more By Kevin Dunleavy A study of T cell responses shows that mRNA vaccines produced by Moderna and Pfizer-BioNTech are as effective against the U.K. and South African variants of COVID-19 as they are against the original strain, among other findings. read more By Andrea Park In 2020, medtech companies raked in $6.4 billion in venture funding, quite a bit above the $5.7 billion investors poured into the sector in 2019. Here’s how they split the pot—and what each company is doing now to top a record-setting year. read more By Amirah Al Idrus Bristol Myers Squibb ponied up $13 billion for MyoKardia last fall, just months after it showed its targeted drug could prevent thickened heart muscle from blocking blood flow in patients with an inherited heart disorder. Now, the Big Pharma is unveiling more data from that phase 3 study, highlighting the drug’s effect on patients’ symptoms and quality of life. read more By Annalee Armstrong In an unprecedented public rebuke, the FDA accused CytoDyn of trying to cherry-pick data from two failed studies of leronlimab in COVID-19 patients to claim the drug is effective. Plus, a stockholder has filed a class action lawsuit alleging that CytoDyn made false and misleading statements about the viability of leronlimab in treating COVID-19, a securities filing shows. read more By Fraiser Kansteiner With vaccines putting COVID-19 on the defense in the U.S., drugmakers are grappling with the question of when, how and whether employees might return to the office. The short answer? Consensus says fully in-person work is going the way of the dinosaur. read more By Beth Snyder Bulik As Biogen and Eisai await an FDA decision for Alzheimer’s candidate aducanumab, they’ve got Samuel L. Jackson on their side—through an Alzheimer’s Association campaign, that is. After years of back-and-forth, and a thumbs-down from an FDA advisory panel, the association’s effort aims to build a grassroots effort to support an approval. Not everyone’s in favor of the campaign, though. read more By Angus Liu Otonomy may have hit a snag with development of its lead ear disorder candidate Otividex, but the biotech is trumpeting an early win for a gene therapy designed for congenital hearing loss caused by mutations in the GJB2 gene. The treatment reduced hearing loss and repaired structural damage in the inner ear in two mouse models. read more By Fraiser Kansteiner Charles River Laboratories will pay $292.5 million in cash for gene therapy CDMO Vigene Biosciences. The move will add viral vector and plasmid DNA manufacturing to Charles River’s cell and gene repertoire—boosting its presence in a CMDO market valued at $2.5 billion globally and growing, the company said. read more By Andrea Park As chief business officer and deputy CEO of Remedee Labs, Gilles Litman will lead the French startup's international growth and product development. read more Resources Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? 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: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. 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. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. | 