WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST As the pandemic heads into a new phase and (yet another) new normal, how will the biopharma industry deal with lasting changes? That includes the birth of a new field of COVID-focused companies—including some superstars—as well as an explosion of decentralized clinical trials that have helped add some much-needed diversity to medical research. Meanwhile, the pace of biotech layoffs has quickened since the start of the year, with few being immune. Fierce Biotech has begun tracking them all in one place. Those stories, plus our top reads of the week, follow below. | |
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Featured Story | By Angus Liu Novartis CEO Vas Narasimhan is giving the Swiss pharma a huge makeover ahead of a possible spinoff of generics unit Sandoz, pushing out three C-level executives and preparing for layoffs. read more |
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Top Stories Of The Week By Annalee Armstrong Layoffs are hitting biotech fast and furious. The Fierce Biotech Layoff Tracker is listing them all from Jan. 1 on. read more By Annalee Armstrong COVID-19 is shifting to an endemic disease, and life is getting back to whatever this new normal will be. But for biotech, the pandemic made for Earth-shattering disruptions that will have a long-lasting impact on drug development timelines—and bottom lines. read more By Angus Liu Bristol Myers Squibb is hoping new launches will offset a wave of forthcoming patent losses for some of its biggest-selling drugs. But in the meantime, CEO Giovanni Caforio just received a smaller pay package. read more By Kevin Dunleavy Viatris has sold a former factory in Morgantown, W.V., to West Virginia University for $1. The school and WVU Medicine will oversee the transformation of the 1.1 million-square-foot complex to a business incubation facility. read more By Annalee Armstrong Sage Therapeutics was mostly focussed on reviewing safety for its Alzheimer’s disease drug, but early data shows the therapy may also improve executive performance, learning and memory in patients with mild cognitive impairment and dementia—but there's a catch. read more By Angus Liu The co-founder of Johnson & Johnson’s partner in freshly FDA-approved CAR-T therapy Carvykti has stepped down unexpectedly as chief scientific officer. In a revelation that suggests an internal power struggle, the former R&D chief told Fierce Biotech he hasn't settled on his next gig. read more By Conor Hale After more than a yearlong wait at the FDA due to the COVID-19 pandemic, Senseonics’ six-month CGM system is finally headed to users with diabetes. read more By Eric Sagonowsky Throughout the COVID-19 pandemic, emerging variants have prompted regulators to force antibody products off the market if testing showed that they had stopped working. Now, GlaxoSmithKline and Vir Biotechnology are the latest victims as the FDA has revoked their emergency use authorization for Xevudy. read more By Angus Liu Existing CAR-T therapies were saved for blood cancer patients who’ve tried multiple treatments—until now. With a first-in-class nod, the FDA has cleared Gilead's Yescarta for certain large B-cell lymphoma patients after one prior therapy. read more By Max Bayer A team of hundreds of researchers spanning dozens of countries has used "10 years worth of data" to nail down precise genes linked with schizophrenia, which could someday lead to new treatment options. read more |  | Webinar: Comparing the FDA, EMA & PMDA In Vitro DDI Guidance Thursday, April 14, 2022 | 11am ET / 8am PT In January 2020, the FDA published its final guidance for industry on in vitro drug-drug interaction (DDI) studies. Dr. Taylor will offer his expert perspectives on major changes, challenges and impacts to development strategies that resulted, compare it with the current EMA and PMDA in vitro guidance documents and discuss how to harmonize your drug development strategies to meet the expectations of all three. Register Now! |
Resources Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Blue Matter, strategic consultants in the life sciences What’s in store for the oncology market in 2022 and beyond? This paper looks at 5 trends driving the market. Sponsored by: Thermo Fisher Scientific Learn how to position quality as a central component within your raw material sourcing strategies for the chemicals used throughout your workflows. Download the free whitepaper from Thermo Fisher Scientific. Sponsored by: Medidata, a Dassault Systèmes company The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates. Sponsored by: Thermo Fisher Scientific Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow. Sponsored by: Oracle Health Sciences Learn about ways to break down regulatory roadblocks and get closer to 100% clarity on regulatory positions to advance decentralized clinical trials in research. Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Drug Development Boot Camp® HYBRID and VIRTUAL in real time November 16-17, 2022 Fierce Medical Affairs Strategic Summit (MASS) East April 12-14, 2022 | New Brunswick, NJ Fierce Promotional Review Committee Compliance and Best Practices Summit April 12-14, 2022 | New Brunswick, NJ Accelerating Immuno-Oncology and Oncology Drug Development Using Humanized Mice Thursday, April 21, 2022 | 12pm ET / 9am PT Fierce Trial Master File Summit May 2-4, 2022 | New Orleans, LA & Streaming Live Fierce Leaders in Life Sciences Forum May 24, 2022 | Free Virtual Event Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Free Virtual Event Fierce Pharma PR & Communications Summit July 19-20, 2022 | Jersey City, NJ Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 2022 | San Diego, CA Fierce Health Payer Summit October 12, 2022 | Free Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Drug Development Boot Camp® HYBRID/VIRTUAL November 16-17, 2022 Fierce New Product Planning Summit November 30 - December 1, 2022 | Boston, MA Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 
