Featured Story | By Nick Paul Taylor Pfizer is preparing to file its COVID-19 vaccine for emergency use authorization (EUA) after passing a key safety milestone. CEO Albert Bourla, Ph.D., said Pfizer now has the median two-month follow-up data needed to secure EUA from the FDA, putting it a step closer to bringing its vaccine to market in the U.S. read more |
| |
|---|
|
|  | Sterile Filling with Eurofins Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials using our state-of-the-art vial filler. Learn More. |
Top Stories By Ben Adams A week after one of its tests in Brazil was stopped amid a safety scare, Chinese biotech Sinovac has published data showing its experimental COVID-19 vaccine can quickly boost an immune response. read more By Amirah Al Idrus After scoring breakthrough and fast-track status from the FDA, the French pharma’s Pompe disease treatment grabbed a priority review tag, setting it up for an FDA decision next spring. The agency also fast-tracked rilzabrutinib, a BTK inhibitor Sanofi picked up in its $3.7 billion buyout of its partner Principia Biopharma. read more Sponsored By Cytiva The right automation design can meet your initial needs and be expanded for your future growth. Planning for success takes a little effort upfront but can pay huge dividends in the long run. read more By Nick Paul Taylor Elevation Oncology has raised $65 million to complete enrollment in a registration-enabling phase 2 cancer trial. The study is assessing seribantumab, an anti-HER3 antibody that failed multiple trials at Merrimack Pharmaceuticals before being reborn as a tumor-agnostic candidate at Elevation. read more By Amy Sokolow Dr. Andy Scharenberg envisions Umoja, which means “unity” in Swahili, as a unification of three developments by scientists at Seattle Children’s and Purdue University. Umoja’s multi-pronged approach relies on three platforms used in sequence. read more By Conor Hale Boston Scientific has retired its entire Lotus Edge heart valve program, effective immediately, leaving a gap in the company’s U.S. transcatheter aortic valve replacement offerings until a new model is approved by the FDA. read more By Angus Liu Scientists at St. Jude Children’s Research Hospital have shed light on how two-way metabolic signaling affects the functioning of the immune system's regulatory T cells. The findings provide potential new targets for treating autoimmune diseases and other disorders. read more Resources 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. | 
.jpg)
