More news on potential therapeutics for COVID-19 came to light this week, but not without the inherent caveats of early-stage R&D and remaining unknowns. Gilead posted data from 53 patients receiving remdesivir under compassionate use, but the lack of a control arm obscured the antiviral’s true effects. Meanwhile, China’s CanSino Bio plans to move its vaccine into phase 2—based on undisclosed phase 1 safety results, and after human testing began just 3 weeks ago in Wuhan. Those stories and our top reads follow below, plus the top 10 drugs expected to see the largest sales increases this year. | |
| Featured Story | Friday, April 10, 2020 In the global race to develop an effective vaccine to protect people against the novel coronavirus, China’s CanSino Bio has leapt ahead. The biotech has started enrollment activities of a phase 2 trial testing its recombinant shot, Ad5-nCoV, in healthy volunteers in the city of Wuhan. |
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Top Stories Of The Week Monday, April 13, 2020 Gilead has posted data on 53 severe COVID-19 patients who received remdesivir on a compassionate use basis. More than two-thirds of the patients improved after receiving remdesivir, although the lack of a control arm makes it hard to tell what role the antiviral played in their recoveries. Wednesday, April 15, 2020 After having to halt enrollment in its severe COVID-19 trial due to a lack of patients, a second test of Gilead’s old Ebola drug remdesivir has befallen the same fate, this time in patients with a milder form of the disease. Some drugmakers work for years to take one of their meds from launch to blockbuster status—a journey defined by competition, market, branding and a dash of luck. But even for pharma's biggest whales, growth-minded executives have a question: What have you done for me lately? Tuesday, April 14, 2020 A phase 1 trial of Moderna’s COVID-19 vaccine candidate has begun enrolling subjects at the highest dose. Moderna shared the update on the COVID-19 study alongside news that people in another trial had anti-Zika antibodies after receiving the biotech’s vaccine against that virus. Friday, April 10, 2020 In quick succession, Gilead Sciences has not only lost an early attempt to overturn a massive CAR-T patent infringement verdict, but now a judge has also ordered hundreds of millions of enhanced damages for plaintiff Bristol Myers Squibb. Tuesday, April 14, 2020 The COVID-19 pandemic is “one of the most significant events any of us have ever experienced,” J&J CEO Alex Gorsky said Tuesday. From there, execs revealed a multibillion-dollar guidance cut and outlined plans for the rest of 2020, offering some hints to what we'll see from pharma as Q1 results roll out. Monday, April 13, 2020 Clinical genomics researchers at Rutgers University have received the FDA’s first emergency authorization for a COVID-19 diagnostic test that uses easy-to-collect saliva samples instead of the more difficult deep nose swabs. Wednesday, April 15, 2020 Uric acid takes a villainous turn in Horizon Therapeutics' latest gout awareness campaign. The acid appears as a personified jagged-edged cartoon bully to an affable kidney in Horizon’s animated two-minute movie to remind nephrologists that the uric acid that causes gout inflammation can damage kidneys. Monday, April 13, 2020 Researchers led by the Emory School of Medicine discovered proteins that govern how cells derive energy from glucose are elevated in the brains and cerebral spinal fluid of patients with Alzheimer's disease. The findings could be used to define new drug targets and develop diagnostics for early detection of the disease. Friday, April 10, 2020 Vir Biotechnology is betting big on its two novel antibodies' potential to treat COVID-19, locking down a range of manufacturing partners to help scale up. Now, in a third major deal, Vir and Samsung will work together to boost production if the treatment proves effective. Resources Sponsored by: BBK Worldwide Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic. 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: Clinical Ink This white paper includes a Phase III case study and discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations. Sponsored by: Research Solutions Turn your drug failures into competitive advantage. Sponsored by: ICON How will US payers evaluate and manage digital therapeutics? Get insights and recommendations on successful market access considerations. Sponsored by: Epsilon Download this e-book to learn 9 ways to enhance the customer experience within healthcare marketing. Sponsored by: Copyright Clearance Center Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have? 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: Patheon, by Thermo Fisher Scientific Poorly soluble molecules hindering your workflow? 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: 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: Clarify Health Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. |