Today's Rundown Novartis posts pivotal data ahead of FDA decision on $9.7B bet Biogen sues over 'brazenly' copied aducanumab drug E-Scape Bio hires GSK neuroscience alum as new CSO [Sponsored] Biogazelle launches novel high-throughput RNA sequencing and data analysis services Soligenix's stock climbs as phase 3 lymphoma trial hits goal Pfizer's Dupixent rival en route to regulatory filings with 3rd positive phase 3 FDA urges clinical researchers to go virtual in response to COVID-19 pandemic Qiagen aims to more than quadruple its COVID-19 reagent production in 6 weeks Roche launches clinical trial of COVID-19 pneumonia hopeful Actemra after backing from China Featured Story | | | Thursday, March 19, 2020 Novartis has published the phase 3 data it hopes will secure approval of cholesterol drug inclisiran. The trials linked the siRNA therapy to sharp declines in levels of LDL cholesterol, shedding more light on why Novartis decided to pay $9.7 billion to get its hands on the drug. |
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Top Stories Thursday, March 19, 2020 Biogen has sued Boston-based biotech Creative Biolabs for allegedly selling copycat versions of its unapproved Alzheimer’s hopeful aducanumab. Thursday, March 19, 2020 Paul Wren, Ph.D., joins E-Scape Bio from GlaxoSmithKline, where he had multiple jobs in its neuroscience unit. He arrives at E-Scape Bio months after the Bay Area biotech revealed phase 1 data for its lead program in Niemann-Pick disease type C, a rare, inherited disorder in which patients cannot transport fats inside cells. Monday, March 16, 2020 Biogazelle NV, a CRO specializing in genomics and transcriptomics, announced the launch of HTPathwaySeq and HTTargetSeq, two cost-effective high-throughput RNA sequencing and data analysis services. Thursday, March 19, 2020 A phase 3 trial of Soligenix’s cutaneous T-cell lymphoma treatment has squeezed under the bar for statistical significance. The finding sent shares in the nanocap drug developer up almost 50% at points in premarket trading. Wednesday, March 18, 2020 Chalk one up for Pfizer’s eczema hopeful—the JAK inhibitor beat placebo at reducing itch and skin inflammation in a third phase 3 study. The data echo the results of two other phase 3 studies testing abrocitinib against placebo, setting the drug up for regulatory filings later this year. Wednesday, March 18, 2020 How can clinical trial sponsors help keep their research going amid the spreading coronavirus outbreak? Use virtual visits, phone interviews, self-administration and remote monitoring, the FDA says. That's according to a new final guidance document the agency published Wednesday describing the potentially unavoidable deviations from trial protocols that may have to be made to maintain the safety of study participants and providers. Wednesday, March 18, 2020 Qiagen is looking to steeply ramp up its worldwide production of the RNA test reagents used to perform certain COVID-19 diagnostics. By the end of the year, the company hopes to provide for more than 20 million monthly tests. Thursday, March 19, 2020 Roche’s arthritis drug Actemra already has backing from Chinese authorities to tackle COVID-19. But the Swiss drugmaker wants to confirm the use through careful examinations rather than relying purely on encouraging anecdotal stories. It's now looking to enroll patients to a global phase 3 in early April. Enrollment Showcase | | | Presented by: Global EMBA for Healthcare & the Life Sciences, University of Toronto Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide. |
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Resources Sponsored by: eClinical Solutions Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor. 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. 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 about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Outer Edge Technology See why innovative BioPharma’s are partnering with Cloud Service Provider’s to design, manage and implement cloud strategies to smooth the path to FDA approval and enhance their competitive prowess. Sponsored by: Metabolon Metabolomics can help you streamline your drug development process by providing the framework to make a stronger, more confident, and more valuable case for a molecule in a shorter timeframe. Sponsored by: Epsilon Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing. Sponsored by: Reprints Desk/Research Solutions 3 ways you may be overspending on scientific literature access, and how to fix them. Sponsored by: Baxter When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed. Outsourcing to a CMO with experience in multiproduct facilities can be an option. Sponsored by: WCG Metrics Champion Consortium Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way. Sponsored by: Eagle Productivity Solutions Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates by implementing the right methodology with a focus on behavior change. Sponsored by: The Kinetix Group Read about the innovative ways payers are making smart moves in the healthcare game. 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: Blue Matter Consulting White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. 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 Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Bioprocessing Summit Europe – Practical Solutions for Today’s Bioprocess Challenges March 24-26 2020 | Barcelona, Spain BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA Clinical Trial Innovation Summit – Technology, Data, Operations, Oversight April 6-8, 2020 | Cambridge, MA Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France U.S. Healthcare Compliance Certificate Program June 8-10, 2020 | Newark, NJ BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 