| Following early hopes and development ups and downs, Gilead’s remdesivir is on its way to providers after its FDA green light two Fridays ago—but the next big challenge is producing enough of it. This week the drugmaker said it signed voluntary, nonexclusive agreements with five generics manufacturers in India and Pakistan, to help build a network that could supply the COVID-19 antiviral to at least 127 countries. Meanwhile, Sanofi’s CEO said the U.S. would be first in line to pre-order an eventual coronavirus vaccine, following its investments in the company’s R&D. Those stories plus our top reads from the week follow below. | |
|
Featured Story | | | Tuesday, May 12, 2020 After scoring an early authorization for its COVID-19 therapy remdesivir, Gilead Sciences has been on the hunt for manufacturing partners to help boost production for the in-demand drug. Through a series of licensing agreements, Gilead has taken the first steps to build that network. |
|
|---|
|
Top Stories Of The Week Wednesday, May 13, 2020 As questions swirl over equitable access to COVID-19 vaccines, Sanofi CEO Paul Hudson has laid out some of his company’s plans should its program succeed, Bloomberg reports. A key point? The U.S. will be first in line. Friday, May 8, 2020 The FDA published results from the first batch of COVID-19 antibody diagnostics to have their accuracy independently evaluated by federal laboratories—starting with the 12 blood tests the agency has already authorized for emergency use against the pandemic. Monday, May 11, 2020 Roche has named Aviv Regev as the new head of Genentech research and early development (gRED). Regev, who currently works at the Broad Institute, will take over as head of gRED when Michael Varney retires at the end of July. Monday, May 11, 2020 With drugmakers and government researchers racing after coronavirus drugs and vaccines, law enforcement agencies say hackers are trying to steal some of their discoveries. Now, after news of a potential cyberattack from Iran, the U.S. plans to implicate China in other hacking attempts on companies leading the COVID-19 pack. Monday, May 11, 2020 Pfizer has dedicated enormous resources to gearing up for hundreds of millions of doses of a possible COVID-19 vaccine. But that massive effort requires a trade-off: Pfizer will need to contract out more manufacturing work to keep up supplies of its existing meds. Tuesday, May 12, 2020 In what will be of little surprise to anyone, the FDA has hitched its fast-track tag to Moderna’s speedy attempt at an mRNA COVID-19 vaccine. Saturday, May 9, 2020 The FDA has authorized its first COVID-19 antigen test, bringing a new category of diagnostic against the disease. Wednesday, May 13, 2020 As part of its $74 billion Celgene pickup, Bristol Myers Squibb offered future payouts based on FDA approval for three key pipeline assets. Already in jeopardy after one delay, that payoff looks even more tenuous now that the FDA has made a rare—and embarrassing—refusal to even consider one of those approval filings. Monday, May 11, 2020 Rinke Bos is a scientist. But under the bright spotlight of COVID-19, the Johnson & Johnson immunologist has also become a media spokesperson, online video cast member and one of the many pharma researchers who symbolize hope for the world. Monday, May 11, 2020 A single injection of the gene that makes the protein follistatin caused a significant buildup of muscle mass in mice while also preventing obesity, reported Washington University researchers. The gene therapy could someday help people who are overweight and suffering from joint pain caused by osteoarthritis, they suggested. Monday, May 11, 2020 Genfit’s lead drug failed a phase 3 study in nonalcoholic steatohepatitis (NASH), joining a growing number of fatty liver prospects that have bitten the dust. The drug, elafibranor, did not beat placebo at improving NASH symptoms without making liver scarring worse, interim data show. The company will analyze those data to see whether it has a path forward in NASH. 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. |
|
|---|
|
Resources 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: 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. 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: 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: 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. | 