WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Vaccine research continues to accelerate. Moderna finally published details on the immune responses teased two months ago—and is churning out doses ahead of a green light. Meanwhile, AstraZeneca is expected to drop positive data at any time, as it works with IQVIA to speed up vaccine trials even further, and Pfizer and BioNTech’s CEOs talk about nabbing their own approvals this fall. But overhyped promises for a quick vaccine could end up hurting the larger fight against the pandemic, warns Merck’s Ken Frazier, with massive development obstacles still ahead. Those stories, plus our top reads of the week, follow below. | |
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Featured Story | By Eric Sagonowsky Politicians, government officials and pharma executives alike have been predicting a COVID-19 vaccine debut by year's end, but Merck CEO Kenneth Frazier doubts that's possible. Instead, those who are promising vaccines later this year could be hurting the overall fight against the pandemic, he figures. read more |
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Top Stories Of The Week By Nick Paul Taylor AstraZeneca and the University of Oxford are set to share “positive news” on their COVID-19 vaccine soon, according to a leading U.K. journalist. The update, which could come as soon as tomorrow, may shed light on how the front-runner vaccine fared in early clinical trials. read more By Ben Adams Operation Warp Speed is living up to its name as, under the project, one of the COVID-19 vaccine front-runners AstraZeneca is teaming up with life science services company IQVIA to boost its work on the shot. read more By Amirah Al Idrus Moderna’s COVID-19 vaccine prompted an immune response similar to those seen in patients who have recovered from infection. Two weeks after receiving a second dose, patients had "robust" levels of neutralizing antibodies against the new coronavirus. Those levels were two to four times higher than levels seen in patients who had recovered from COVID-19 infection. read more By Eric Sagonowsky Moderna and its partners in the federal government are just now gearing up for a late-stage COVID-19 vaccine trial set to launch later this month. But at the same time, the mRNA biotech is prepping a supply of doses for quick shipment if the shot gets an FDA go-ahead. read more By Eric Sagonowsky Moderna has never scored a commercial approval for any of its drugs or vaccines, but analysts with Jefferies think the company has a winner in its COVID-19 shot. The team is projecting around $2 billion in 2021 sales, and $5 billion in sales over the next few years. read more By Eric Sagonowsky Gilead Science’s remdesivir is on the very short list of drugs that have posted positive data in COVID-19, but one U.S. lawmaker is joining a chorus arguing the company priced the medicine too high. Taxpayers spent nearly $100 million to save the drug from the "scrapheap," the lawmaker wrote, and are being repaid with "price gouging." read more By Ben Adams Pfizer and German mRNA partner BioNTech have grabbed an FDA fast track label as they look to start a late-stage, 30,000-patient COVID-19 vaccine test before the month is out. read more By Kyle Blankenship The Trump administration has dumped billions into COVID-19 vaccine development and manufacturing as part of its Warp Speed initiative. Now, with vaccine makers moving rapidly toward approval, the administration has high hopes at least one shot candidate will start churning out doses within the next six weeks. read more By Arlene Weintraub By studying the antibody response to COVID-19 in 12 patients and immune cells from 48 healthy people, German researchers uncovered 28 antibodies that neutralize the virus. They're now working with Boehringer Ingelheim to advance the drugs into clinical testing. read more By Kyle Blankenship Novartis' blockbuster Entresto missed a big opportunity last year with a failed late-stage trial in certain heart failure patients without a current approved treatment. Despite that loss, and a slow start to market, analysts say Entresto is picking up steam with cardiologists—and it could translate into a major sales boost. read more By Conor Hale The world has changed since Thermo Fisher Scientific reached a hard-fought, $11.5 billion agreement to acquire Qiagen, announced in the first days of March after months of negotiations and public rumors. read more | | Webinar: Metabolites in Safety Testing (MIST): Analytical Strategy Wednesday, July 29 | 1pm ET / 10am PT Regulatory agencies have provided recommendations on when and how to identify and characterize drug metabolites to ensure their non-clinical toxicity has been adequately evaluated. This presentation will review the origins of these recommendations and the specific requirements that need to be considered in designing studies. Register now. |
Resources Sponsored by: Lonza Pharma & Biotech A novel spray-dried dispersion platform has been developed to faciliate high drug load applications Sponsored by: Florence Complimentary Download: How to connect to study sites remotely via the Electronic Investigator Site File (eISF) to streamline clinical operations. Insights from the largest eISF network in the world. With today’s rapidly evolving environment, we have created this five-part content series to highlight pressing issues and topics that are more pertinent today than ever before. Sponsored by: Cambrex The industry trend of outsourcing to CDMOs continues. With more services, capabilities, facilities, and employees than ever before, our experts have contributed more articles to our biggest eBook yet. Sponsored by: EVERSANA How predictive analytics and machine learning have the potential to transform healthcare by predicting “Patient Switching Behaviors.” 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: PRA Health Sciences Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need. Sponsored by: Systech Get an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain. Sponsored by: Automation Anywhere Built on advances in Artificial Intelligence (AI), data mining, and information integration into various systems at 100% accuracy, the new era of intelligent automation is integral to life sciences for devising new treatments faster and at a lower expense. Sponsored by: Research Solutions Learn four ways to squeeze more value from your limited R&D resources. Sponsored by: BioAnalytix Download this eBook and Learn the Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies 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. | 