| How does $4,460 per patient sound? The drug price watchdog ICER said that would be a fair offer for Gilead’s remdesivir, the first antiviral to show benefit against the novel coronavirus in a randomized study, and the latest to receive the FDA’s OK. But even at $1,000 Gilead could make $1 billion in sales, as it gears up to treat 1 million patients by year’s end. On a call with investors, CEO Daniel O’Day said the pandemic may shift attitudes on pricing in Washington, as the public watches Big Pharma tackle the crisis—however, scrutiny on drug costs isn’t going away completely, he added. Featured Story | | | Monday, May 4, 2020 While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically. |
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|  | May 13, 2020 | 11am ET / 8am PT In a continuous manufacturing process, products are produced via an integrated series of modular unit operations. As a result, this process has greater control, no scale up and can provide multiple benefits in both development and commercial manufacturing. Register Today! |
Top Stories Of The Week Friday, May 1, 2020 Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine. Pharma companies today need to figure out how social media helps them reach the right influencers and key opinion leaders, drive traffic to websites or change perceptions of the products or company. Monday, May 4, 2020 With less than six months to go until the U.S. elections, the drugmakers find themselves in a different position than expected at the start of the year. Because of the COVID-19 pandemic, the public will recognize pharma's ability to innovate and help, Gilead CEO Daniel O'Day said. Wednesday, May 6, 2020 The FDA has delayed its decision on whether to approve Bristol Myers Squibb’s CAR-T cell therapy by three months. Bristol Myers attributed the delay to its submission of additional information upon the request of the FDA. Thursday, April 30, 2020 Single-domain antibodies or “nanobodies” produced by llamas' immune systems have inspired a potential treatment for COVID-19 that works by binding to the spike protein on the coronavirus that causes the illness. The researchers that created the treatment have shown it neutralizes the virus in cell cultures, and they're now planning animal studies. Friday, May 1, 2020 Johnson & Johnson is ready to take treatment time for multiple myeloma patients down from hours to just minutes with its new formulation of blockbuster Darzalex, and the drug's latest FDA approval couldn't come at a more opportune time for the New Jersey drugmaker. Friday, May 1, 2020 AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment. Thursday, May 7, 2020 Moderna is finalizing the protocol for a phase 3 trial of its COVID-19 vaccine with a view to starting the study early in the summer. The establishment of the timeline, which follows FDA clearance to run a phase 2 trial, puts Moderna on track to win approval for its mRNA vaccine mRNA-1273 next year. Friday, May 1, 2020 The successful activation of T cells is critical to the immune system's ability to clear infections. A retrospective study in China found that COVID-19 patients had remarkably low T-cell counts in their blood, while some pro-inflammatory cytokines such as IL-6—which Roche’s Actemra targets—were elevated. Monday, May 4, 2020 Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. Tuesday, May 5, 2020 After allowing unreviewed antibody tests to pervade the U.S. market for weeks, the FDA is closing its open-door policy for coronavirus blood serology tests—bringing their oversight more in line with the molecular diagnostics used to confirm active cases of COVID-19. Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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Resources Sponsored by: Patheon, by Thermo Fisher Scientific Continuous Manufacturing vs. Batch for Oral Solid Dose Sponsored by: Cenduit, LLC Download this case study to read about how Cenduit navigated these challenges, and successfully supports the trial sponsor to execute the umbrella trial with agility. Sponsored by: Patheon, by Thermo Fisher Scientific Download this whitepaper to learn more about the importance of an integrated approach to formulation. 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. Presented by: Optum The immediacy of EHR data availability can be significantly impactful, particularly as the health care system works to address COVID-19. Download this whitepaper to learn more. 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. Sponsored by: Recro Gainesville Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project. Sponsored by: AMRI In this webinar, the featured speaker will explore the key advances and critical hurdles for translating these emerging molecular biology technologies into real-world applications and commercial processes. Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug. Download the whitepaper. 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: Lonza This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies. 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: Blue Latitude Health Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns. 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: 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. | 
