WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST The Trump administration’s “Operation Warp Speed” vaccine development project named its Big Pharma finalists, with the goal of delivering an effective COVID-19 vaccine in the seven months left in the year. AstraZeneca, Merck, Pfizer, Johnson & Johnson and Moderna will have access to additional government funding, clinical trial assistance and manufacturing help, according to reports. But other efforts were left off the list, including Inovio, Novavax and a partnership between Sanofi and GlaxoSmithKline. Meanwhile, ASCO’s virtual meeting brings new CAR-T data from Gilead and Allogene. Those stories and more follow below. | |
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Featured Story | Wednesday, June 3, 2020 The Trump administration has selected its COVID-19 vaccine finalists for Operation Warp Speed, which aims to deliver safe and effective coronavirus vaccines to Americans by the end of the year, The New York Times reports. read more |
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Top Stories Of The Week Friday, May 29, 2020 One of the European Commission’s stipulations for Takeda’s purchase of Shire was that it divest the biopharma’s inflammatory bowel disease candidate SHP647. read more Friday, May 29, 2020 After the FDA identified a likely carcinogen in samples of the broadly used diabetes med metformin, recalls appeared likely. Now it's official: The FDA is pushing five metformin manufacturers to pull their products, following in the footsteps of Zantac and blood pressure meds yanked for the same reason. read more Thursday, June 4, 2020 A few years ago, one of our Fierce Life Sciences editors met a Big Pharma R&D chief for the first time. “You’re the ones with the scary name,” he joked. It was a glancing reference, but the comment stuck, and for good reason. We had never articulated, for ourselves or anyone else, what being Fierce actually meant. read more Friday, May 29, 2020 Leaders from four of the biggest drugmakers in the world spoke about rising to the challenge of defeating the global pandemic as scaled-up trials and a potential approval peek over the horizon. read more Friday, May 29, 2020 Sanofi's new CEO Paul Hudson has been making his mark in the company's C-suite, and his latest round of executive shuffling will impact the company's top vaccines job—even as it's prepping its GlaxoSmithKline-partnered COVID-19 candidate. Sanofi Pasteur chief David Loew is jumping ship to fellow French pharma Ipsen as CEO. read more Tuesday, June 2, 2020 Merck CEO Ken Frazier has spoken passionately about racial inequality in America before. Monday, amid protests and rioting over George Floyd's death, he made that passion personal. Floyd “could be me or any other African American man,” Frazier said in an interview on CNBC, going on to relate his own experiences growing up in Philadelphia—and how businesses can work to bridge opportunity gaps. read more Tuesday, June 2, 2020 In a pandemic world, the biotech funding environment couldn’t look brighter, and today Pfizer shone its own light. read more Friday, May 29, 2020 Researchers at the University of Maryland are developing a simple, experimental diagnostic test for COVID-19 that could provide a visual result in 10 minutes, without any laboratory equipment. read more Friday, May 29, 2020 Gilead Sciences is working to move CAR-T therapy Yescarta into other types of non-Hodgkin lymphoma, and if data from an interim trial look-in are any indication, it’s well on its way. In patients who'd relapsed or proven treatment-resistant, Yescarta spurred a benefit in 93% and cleared cancer completely in 80%, interim study data show. read more Friday, May 29, 2020 Allogene released expanded data from a phase 1 trial of its off-the-shelf, CD19-directed CAR-T, ALLO-501, plus its antibody ALLO-647. The response rate wasn't quite as impressive as what the company reported two weeks ago, but the details could generate some excitement among Wall Street analysts. read more Enrollment Showcase | Sponsored by: University of Florida College of Pharmacy Position yourself as a precision medicine leader with the online graduate program in precision medicine. Learn the latest in genomic technologies and precision medicine therapies from experts in research and implementation. Join the future of health care with the flexibility and convenience of an online program. |
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Resources Sponsored by: Blue Matter, strategic consultants in the life sciences White paper describing 7 keys to success for any biopharma company that is entering (or thinking about entering) Europe. Sponsored by: Copyright Clearance Center Dive into the history of biomedical classification and how these systems have evolved to address new technology and use cases. Sponsored by: Clinical Ink This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations. Sponsored by: Clinical Ink Learn how GI specific data capture solutions can support virtual and hybrid trials during COVID-19. 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. 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: 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: 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: 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. |
