WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST The clamor for transparency has been steadily growing for COVID-19 vaccine developers. Moderna, AstraZeneca and Pfizer and BioNTech responded by publishing their protocols—detailing their measurements of success as well as a broad timeline of when sufficient results will be expected. Meanwhile at ESMO’s annual meeting, Amgen’s KRAS drug shrunk lung tumors in a third of patients, while Merck and Eisai showed where they might take their Keytruda-Lenvima combination next. Those stories plus our top reads of the week follow below. | |
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Featured Story | By Ben Adams The clamor for more transparency from the leading pandemic vaccine contenders has been getting louder, especially after AstraZeneca’s trial was briefly stopped in the U.K. (and is still on hold in the U.S.). read more |
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Top Stories Of The Week By Kyle Blankenship Once cleared by the FDA of a probable carcinogen, generic diabetes med metformin has now become the target of a growing number of recalls. This week, a seventh drugmaker joined the metformin recall parade after finding high levels of the potential cancer-causing contaminant NDMA. read more By Carly Helfand Merck & Co. already has an approval for Keytruda in tandem with Lenvima—a drug it shares with Eisai—in endometrial cancer. But the partners are trying to take the combo into additional cancers, and new data provide a glimpse of where it might go next. read more By Amirah Al Idrus After releasing dribs and drabs about its closely watched KRAS inhibitor, Amgen is pulling the curtain on full data. The treatment, known as sotorasib or AMG 510, curbed tumor growth in 88% of patients with non-small cell lung cancer, shrinking tumors in one-third of patients. read more By Ben Adams Blocking tau appears to be just as fruitless as clearing amyloid buildup when it comes to helping Alzheimer’s disease patients. read more By Angus Liu Monday, Johnson & Johnson’s CAR-T partner Legend Biotech and its parent company, Chinese CDMO Genscript Biotech, dropped the bombshell that Fangliang “Frank” Zhang, chairman of Genscript and recently appointed CEO of Legend, has been put under “residential surveillance” by China law enforcement. read more By Conor Hale The initial immunoassay will measure neurofilament light chain protein levels, found in the blood and cerebrospinal fluid, which are linked to nerve damage. read more By Eric Sagonowsky Defending its blockbuster MS drug Tecfidera from generics hasn't been easy for Biogen lately, and the painful trend continued this week with a court ruling that clears the way for more copycat drugs to launch—and siphon off most of its $3.3 billion in U.S. sales, an analyst said. read more By Angus Liu Novartis was gunning for an FDA application in 2021 for a new, market-expanding Zolgensma formulation. The company planned to use phase 1/2 data to make its case for the second-gen gene therapy—and move into a larger group of spinal muscular atrophy patients that could yield bigger sales. Instead, the FDA is demanding a full phase 3 trial. read more By Angus Liu Scientists at University Hospital Zurich showed that immune signaling molecule IL-2 might provide vital support to immuno-oncology agents by engaging with dendritic cells, which function as the messengers of the immune system by presenting antigens to T cells. read more Resources Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. Sponsored by: 4G Clinical This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials. Sponsored by: EVERSANA How independent drug launch and commercialization can lead to higher market capitalization. Sponsored by: AMRI Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development. Sponsored by: LexisNexis Risk Solutions Avoid severe compliance penalties by staying on top of evolving laws. Sponsored by: Quotient Sciences This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >> Sponsored by: Clarify Health In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy. Sponsored by: Benchling Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide. Sponsored by: Thermo Fisher Scientific Don’t oversimplify your solubility challenges. Sponsored by: Clinical Ink Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Thermo Fisher Scientific Download the whitepaper to learn more. Sponsored by: LexisNexis Risk Solutions Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information. Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Optum Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. 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. | 