AstraZeneca probes 'mistake' behind 90% COVID-19 vaccine efficacy Immunocore's TCR bispecific improves survival in solid tumor phase 3 Russia posts 91% efficacy for COVID-19 vaccine after jumping the gun to approval Anti-aging biotech Elevian raises $15M as it looks to the clinic Hoping for an endgame, GSK kick-starts phase 3 RSV vaccine trial in pregnant women Twist Bioscience's COVID-19 'nanobodies,' inspired by llamas, show promise in hamsters FDA clears Baxter's virtually connected, in-home peritoneal dialysis system Featured Story By Nick Paul Taylor AstraZeneca is looking into why the accidental use of a half-dose primer vaccine appears to make its COVID-19 regimen more effective. The half-dose was given to some participants due to an error but is now AstraZeneca’s best hope of delivering efficacy comparable to mRNA vaccines. read more |
| |
---|
| Top Stories By Nick Paul Taylor Immunocore’s tebentafusp has improved overall survival in metastatic uveal melanoma patients. The phase 3 success marks a landmark for the use of T-cell receptor therapeutics and bispecifics in solid tumors. read more By Amirah Al Idrus Russia shocked the world in August when it approved a COVID-19 vaccine based on early data, leapfrogging global vaccine players like Pfizer and AstraZeneca. Now, the vaccine’s maker is reporting data from nearly 19,000 people showing it is more than 90% effective. read more By Ben Adams Early-stage biotech Elevian has raised $15 million as it looks to target multiple age-related diseases. read more By Ben Adams A month after seeing a "robust immune response" from a clutch of RSV vaccine hopefuls, GlaxoSmithKline is kicking off a key late-stage test for the infectious respiratory disease. read more By Angus Liu Single-domain antibodies, or “nanobodies,” inspired by llamas, have been proposed as potential treatments for COVID-19. Twist Bioscience has two such candidates that the company plans to develop as nasal sprays, and they've shown early promise in animal models. read more By Conor Hale Baxter has received clearance from the FDA for the latest version of its automated peritoneal dialysis system designed for home use, combining it with a digital platform that aims to help patients with kidney disease manage their care remotely. read more Resources 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: WCG Need additional site resources for your current or upcoming clinical trial? 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: Medidata Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now. 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: Thermo Fisher Scientific One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. 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: Thermo Fisher Scientific Anticipate early development challenges to avoid rework and costs. Sponsored By: Cytiva Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article. Sponsored by: LexisNexis Risk Solutions Get insights into healthcare decision-makers networks. 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: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. 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. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event |