WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST With nearly 35 million global cases and at least 1 million deaths so far, it’s clear COVID-19 has defined this year and will shape those to come. But unlike previous pandemics faced by the human race, today we bring more tools and technology to bear. Our list of 2020’s Fierce 15 biopharma companies have shown how fast the industry can respond to a novel threat—from mapping the novel coronavirus’ genome, to developing antibodies, to launching clinical trials in a matter of months. But why stop there? Several CEOs we talked to say these efforts could set the stage for tackling cancer and other devastating diseases. Our full list of winners, plus our top stories of the week, follow below. | |
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Featured Story | By Ben Adams Whilst COVID-19 consumes our minds and the current budgets of the world, cancer will still develop and kill; genetic abnormalities will create rare diseases with no treatment; millions will still die from influenza. This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology. read more |
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Top Stories Of The Week By Eric Sagonowsky Pfizer CEO Albert Bourla and his vaccine partner BioNTech have said the companies expect phase 3 data by the end of October—and that an FDA application could follow. But more than 60 researchers and bioethicists urged the partners to wait for more safety data before submitting their shot for a green light, Bloomberg reports. read more By Ben Adams Johnson & Johnson has posted an early peek at its phase 1/2 trial data for its pandemic vaccine hopeful that last week started late-stage tests. read more By Nick Paul Taylor Moderna has published data from adults aged 56 years and older who received its COVID-19 vaccine. Results from the small cohort suggest the vaccine triggers comparable immune responses in younger and older adults. read more By Eric Sagonowsky With a pandemic spreading globally, vaccines have moved to the forefront of the public’s attention—naturally focused on COVID-19 candidates moving at record speeds. But biopharma companies haven’t given up on their other promising programs. These are the top late-stage vaccine prospects in pipelines today. read more By Angus Liu The FDA handed Gilead Sciences and its partner Galapagos a surprising no-go for blockbuster hopeful filgotinib last month. But that didn’t stop regulators in Japan from making a different decision on the rheumatoid arthritis med, now dubbed Jyseleca. read more By Amirah Al Idrus The FDA slapped a partial clinical hold on the phase 2/3 study of Inovio’s COVID-19 vaccine because it has “additional questions” about the trial, the company revealed on Monday. The hold is not a response to side effects seen in a phase 1 study of the vaccine and so, will not affect that trial, nor any of Inovio's other work. read more By Arlene Weintraub A new atlas of nearly 500,000 cells from 14 donated hearts was designed to help researchers build their understanding of how a healthy heart operates—and what goes wrong when heart disease develops. Its developers believe the cardiology community will be able to use the atlas to develop personalized treatments for heart disease. read more By Angus Liu Behzad Aghazadeh, the Immunomedics executive chairman who previously worked hard as an activist investor to derail a $2 billion licensing deal with Seattle Genetics, is now on tap for a whopping $2.35 billion from selling the roughly 11% stake he has in Immunomedics shares to Gilead. Contrary to what industry watchers assumed, the Big Biotech didn't fight through a bidding war to land the $21 billion deal. read more By Kyle Blankenship With all eyes on the hunt for a COVID-19 vaccine, drugmakers like New Jersey's Johnson & Johnson are scouring the market for manufacturing partners to help meet what would be global demand for their shots. With a couple already in hand, J&J is now turning to a Michigan CDMO to help keep up. read more By Conor Hale There’s a new type of line to wait in at the airport: United Airlines said it will begin providing COVID-19 screening tests for passengers on certain routes, allowing those who test negative to skip any quarantine requirements after they land. read more By Sharon Klahr Coey Allergan Aesthetics taps actress and producer Malin Akerman as brand ambassador for new body contouring campaigns for its CoolSculpting and CoolTone treatments. read more Resources Sponsored by: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. Sponsored by: Guidehouse While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products. Sponsored by: Blue Matter Consulting Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. Sponsored by: LexisNexis Risk Solutions A complete Life Science Industry Snapshot in One Report Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. Sponsored by: 4G Clinical This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials. Sponsored by: EVERSANA How independent drug launch and commercialization can lead to higher market capitalization. Sponsored by: AMRI Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development. Avoid severe compliance penalties by staying on top of evolving laws. Sponsored by: Quotient Sciences This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >> Sponsored by: Clarify Health In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy. Sponsored by: Benchling Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide. Sponsored by: Thermo Fisher Scientific Don’t oversimplify your solubility challenges. Sponsored by: Clinical Ink Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Thermo Fisher Scientific Download the whitepaper to learn more. Sponsored by: LexisNexis Risk Solutions Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information. Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. 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. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. | 
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