WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST This week the FDA opened up Gilead’s remdesivir as a treatment for all people hospitalized with COVID-19, despite mixed data that doesn’t point to a preferred group of patients or how long treatment should last. Meanwhile the antiviral, also known as Veklury, is also being developed as an inhaled powder that could expand its reach even further. Elsewhere, AstraZeneca kicked off a 30,000-person trial of its vaccine in the U.S.—and long-time treatments for coronavirus-related diseases in cats may soon make their debut against COVID-19. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Arlene Weintraub University of Alberta scientists reported that a drug being developed by Anivive Lifesciences to treat feline infectious peritonitis prevented human coronaviruses from replicating in cell studies. They believe the drug should be rushed into human trials to treat patients with COVID-19, given that it has proven safe and effective in cats. read more |
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|  | Webinar: Accelerating Pharma’s Evolution Towards a Perfect Omnichannel Engagement September 15, 2020 | 11am ET / 8am PT This webinar reviews the current strategies to better engage with HCPs and patients and covers practical considerations for achieving a perfect omnichannel marketing experience. Panelists will also discuss about the enablers which makes omnichannel experience possible including the types of data needed, and the role AI and predictive analytics play. Register now. |
Top Stories Of The Week By Kyle Blankenship Drugmakers on the hunt for a COVID-19 vaccine have promised massive supply rollouts in the coming months if their candidates pass regulators' scrutiny. But promises and results are very different things: For two highly touted mRNA-based shots, cold-storage requirements could hobble their launches. read more By Nick Paul Taylor AstraZeneca has begun a U.S. phase 3 clinical trial of its COVID-19 vaccine candidate AZD1222. The BARDA-funded study will enroll 30,000 adults at sites in the U.S. and some other countries in which the virus is prevalent. read more By Kyle Blankenship Pfizer and Bristol Myers Squibb's anticoagulant superstar Eliquis has raced out to blockbuster sales in recent years and a big-time lead over its its warfarin alternative competitors. Looking to pad that lead, the partners are building a body of real-world evidence for their drug, and in one French study the results are mostly promising. read more By Ben Adams After being bounced by Bristol Myers after its Celgene takeover, Jounce is courting again, this time an early romance with Gilead. read more By Fraiser Kansteiner A University of Texas research team had already developed its thin-film freezing technology when COVID-19 struck. With the drug delivery platform primed to create dry powder formulations of established meds, the team set to work creating an inhaled version of the antiparasitic niclosamide for coronavirus testing—and then targeted Gilead Sciences' remdesivir. read more By Eric Sagonowsky Amid daily headlines about COVID-19 vaccines and trends, Gilead's Veklury, also known as remdesivir, remains the only antiviral drug authorized to treat the illness. With a new move from the FDA, the medicine's emergency green light is a little broader—despite some lingering questions about its efficacy. read more By Conor Hale The Trump administration has cut short its COVID-19 ventilator contract with Philips before a majority of the order could be delivered to the national stockpile. read more By Nick Paul Taylor Novartis has presented midphase data showing paroxysmal nocturnal hemoglobinuria patients can safely transition from Alexion’s Soliris to its experimental oral candidate LNP023. read more By Beth Snyder Bulik The Department of Health and Human Services plans to spend $250 million in media communications to “defeat despair and inspire hope” around the coronavirus pandemic, Politico reports. In a document sent to potential bidders, the agency detailed plans for a broad campaign across media and channels. read more Enrollment Showcase | Presented by: Biotility Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more. |
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Resources 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. Sponsored by: LexisNexis Risk Solutions 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: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment 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: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. 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: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. 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. | 
