AstraZeneca COVID-19 vaccine data hint at single-dose efficacy, effect on asymptomatic cases Public Citizen calls out 'inappropriate close collaboration' between FDA and Biogen, urges investigation Lilly's tirzepatide drives deep drops in blood sugar and body weight in diabetes phase 3 Sponsored: From Conquering COVID-19 to Curing Cancer, New York City Charts the Future of Life Sciences Ex-GSK immunology chief takes over oncolytic virus biotech Candel as it ramps up its pipeline Sponsored: Biotech IPOs: Navigating the New Landscape Sanofi, Evotec veteran Carter joins Fierce 15 winner Dewpoint Boehringer snaps up virology partner to beef up immuno-oncology work Roche to supply antibody tests to Moderna's COVID-19 vaccine trial Preventing Type 1 diabetes by targeting a T-cell protein Featured Story | By Nick Paul Taylor Full data from late-phase trials of AstraZeneca’s COVID-19 vaccine have pointed to the potential for AZD1222 to work after a single dose and prevent asymptomatic cases but left key questions about the efficacy of the candidate unanswered. read more |
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| | Balancing Cost, Time and Quality When you support many clinical studies, one thing is certain—you gain experience. Explore critical factors in the packaging design process that can help to deliver the best possible outcome for your study. |
Top Stories By Ben Adams Activist group Public Citizen is crying foul on an “inappropriate close collaboration” between the FDA and Biogen surrounding the pharma’s controversial Alzheimer’s disease drug aducanumab and the related FDA advisory committee documents. read more By Nick Paul Taylor Eli Lilly’s tirzepatide has significantly reduced blood sugar and body weight in Type 2 diabetics in a late-phase clinical trial. The release of the top-line data provides early validation of Lilly’s decision to place a big bet on the dual GIP/GLP-1 agonist. read more Sponsored By: NYCEDC The life sciences sector in New York City is on pace to raise $1B in venture funding in 2020, up from just $40 million ten years ago. In addition to NYC’s outstanding talent and funding, the city is rich with life science real estate offerings across the five boroughs. read more By Amirah Al Idrus After at stint at Flagship Pioneering that was “one of the best experiences” in his career, Paul-Peter Tak, M.D., Ph.D., has a new gig. The former GlaxoSmithKline immunology chief takes over at Candel Therapeutics as the company gears up for a busy year. read more Sponsored By: RBC Capital Markets Biotech IPO markets are booming. But even in a boom, identifying the right time to go public and telling your post-IPO story for how capital deployment translates to value for investors is critical. read more By Ben Adams Dewpoint Therapeutics has nabbed infectious disease specialist Kara Carter, Ph.D., as its senior vice president of discovery biology. read more By Amirah Al Idrus Boehringer Ingelheim teamed up with German biotech Labor Dr. Merk & Kollegen in 2015 on viral-based therapies. Five years on, it’s swallowing up its partner, a move it thinks will boost development of its oncolytic, or cancer-killing viruses, and cancer vaccines. The companies did not disclose financial details. read more By Conor Hale The partnership aims to draw the line where antibody protection begins, and provide answers on whether booster shots will be needed to maintain immunity. read more By Angus Liu In Type 1 diabetes, the body’s immune system mistakenly attacks insulin-making beta cells in the pancreas. Scientists at the University of Utah School of Medicine said they've found a way to rein in that autoimmune response by targeting a protein called OCA-B that’s essential for T-cell activation. read more Resources Sponsored by: ZS Learn how Aerie fueled their product launches with advanced analytics. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Thermo Fisher Scientific Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed. Sponsored by: Cytiva Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored By: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! 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: 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: 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 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event | 