WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST One year and 500,000 deaths into the COVID-19 crisis, the U.S. is looking to Pfizer, BioNTech, Moderna—and soon, Johnson & Johnson—to produce as many vaccine doses as possible. Pfizer plans to increase its manufacturing from 4 to 5 million per week up to 13 million by mid-March, while Moderna, which has already delivered 45 million shots, hopes to double its monthly shipments by April. Meanwhile, the FDA’s vaccine panel meets today to discuss J&J’s single-dose vaccine, after reviewers described it as safe and effective. If authorized, the country could have its third inoculation option, with 20 million doses available by the end of next month. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Angus Liu Novo Nordisk’s Ozempic is already ducking it out with Eli Lilly’s Trulicity in the once-weekly diabetes treatment field. But looming competition from the Indianapolis pharma could pose a serious threat, especially at its lowest tested dose, one analyst said. read more |
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Top Stories Of The Week By Ben Adams After a flurry of CRO takeovers a few years back, the megamerger market went quiet. But, today, as the industry hauls itself out of the pandemic funk of 2020, Icon is getting out its checkbook in a massive $12 billion buyout of PRA Health. read more By Fraiser Kansteiner Pfizer, Moderna and Johnson & Johnson execs say they're working all the angles on increasing COVID-19 vaccine production and expect to amp up weekly deliveries by tens of millions by the end of March. Moderna plans to double its output by April, while Pfizer aims to roll out 13 million doses a week next month. read more By Nick Paul Taylor Sanofi and GlaxoSmithKline have begun a phase 2 clinical trial of a new version of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. The study start comes around two months after weak clinical data forced the partners to rethink the antigen formulation. read more By Eric Sagonowsky Sanofi hasn't abandoned its COVID-19 vaccine hopes despite a setback in the high-stakes race, but as it moves two separate technologies forward, it's also pitching in to make vaccines for its usual rivals. The deal is the latest pandemic tie-up among Big Pharma companies. read more By Amirah Al Idrus FDA staffers endorsed Johnson & Johnson's COVID-19 vaccine as safe and effective in briefing documents released Wednesday, ahead of an advisory committee meeting scheduled for Friday. The documents reiterated that the vaccine was 66.1% effective at preventing COVID-19 infection at least 28 days after vaccination, with “no specific safety concerns identified that would preclude issuance of an EUA.” read more By Amirah Al Idrus Multiple companies aim to surmount the limitations of CAR-T therapy by going beyond T cells and engineering cell therapies based on natural killer cells or macrophages instead. Orna Therapeutics’ solution is more holistic: bringing CARs directly to a patient’s immune cells to help them kill cancer. The company uncloaks with $100 million to develop this approach, among others, all of which are based on engineered circular RNA. read more By Angus Liu COVID-19 products aren’t guarantees of market cap growth at biopharma companies these days—and a lack of them doesn’t deprive a drugmaker, either—if a year-end comparison between 2020 and 2019 is any indication. read more By Ben Adams As Moderna ramps up its COVID-19 vaccine efforts and has made one of the speediest moves from a hyped-up preclinical biotech to a commercial entity hoping to help save the world, its chief medical officer, Tal Zaks, M.D., Ph.D., is set to leave for pastures new. read more By Conor Hale Insilico Medicine's computer networks uncovered a never-before-tried biological target linked to idiopathic pulmonary fibrosis and designed a novel molecule from scratch to potentially treat the disease—for less than $2 million and 18 months of time. read more By Arlene Weintraub Precision BioSciences' gene editing technique produced a stable lowering of PCSK9 protein and LDL cholesterol in nonhuman primates for three years, according to a study led by University of Pennsylvania researchers. The company is developing the one-time treatment as an alternative to drug treatments for familial hypercholesterolemia. read more By Angus Liu Novartis sales took a hit from COVID-19, and so did CEO Vas Narasimhan’s 2020 pay. The Swiss pharma handed its CEO a $11.6 million compensation package in 2020 as his annual bonus—a large part of which was tied to Novartis’ financial performance last year—turned out to be a drag. read more By Eric Sagonowsky Pfizer's already gracing headlines worldwide with its COVID-19 vaccine rollout. Now, it's making a big splash in Tampa Bay. The drug giant is opening a “global capability hub” in the city, bringing multiple services—including finance, human resources, digital, and sourcing—to one office. read more By Beth Snyder Bulik In a stunning reversal from just one year ago, almost two-thirds of Americans now rate the pharma industry positively, The Harris Poll finds. Back in January 2020, as the pandemic was just heating up in the U.S., only about a third gave the industry good marks. read more Resources 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: Medidata, a Dassault Systèmes company 8 parameters to optimize your “Path to Virtualization” across site- and patient-centric capabilities in this Sponsor Edition eBook. Sponsored By: LabVantage Solutions Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored By: Acorn AI, a Medidata Company Acorn AI has developed a flexible and scalable Commercial Data Model that provides pharmaceutical companies with the data-driven insights required to respond to the industry’s ever-changing landscape. Download the whitepaper to learn how Acorn AI’s intuitive data model enables launch success and more. 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. |
