Pfizer, BioNTech see stock, hope soar as they say COVID-19 vax 90% effective, plot November EUA FDA panel slams Biogen's controversial Alzheimer's med Sanofi, Alnylam’s hemophilia med fitusiran is on hold—again Best Practices for Research Sites: Effectively Using Patient Recruitment Advertising Dollars EIP Pharma tees up phase 3 for ex-Vertex dementia drug Decibel scores $82M to push hearing loss gene therapy into the clinic RemeGen grabs one of the world's largest ever biotech IPOs Fierce Pharma Politics—Biden puts COVID-19 transition task force on the job Oxford's rapid COVID-19 test acquired by Prenetics to screen airport passengers in London, Hong Kong Attacking pancreatic cancer with a novel immuno-oncology drug conjugate Featured Story By Ben Adams Pfizer and German mRNA biotech partner BioNTech have released an early look at their experimental pandemic vaccine, and the news is good. read more |
| |
---|
| Top Stories By Amirah Al Idrus Biogen shocked the biopharma world last year when it resurrected its once-failed Alzheimer’s drug based on findings from a post hoc analysis. But its hopes for a speedy FDA nod look dashed as a panel of outside experts picked apart the data supporting the new drug application, panning it in multiple votes. read more By Amirah Al Idrus Sanofi hit pause on the development program for fitusiran, its Alnylam-partnered RNA-silencing hemophilia treatment, thanks to new side effects seen in clinical trials, a trio of hemophilia organizations announced on Friday. read more By WCG Are you looking to optimize your site’s patient recruitment advertising dollars? WCG’s experienced team of patient recruitment experts can help your site efficiently use your advertising funds by creating customized recruitment campaigns for any of your studies, and we’ve also curated a list of best practices to ensure your spend sees the best ROI. read more By Amirah Al Idrus Dementia with Lewy bodies may be among the most common types of dementia, but there aren’t many treatment options for the disease. EIP Pharma is one step closer to changing that, with phase 2 data showing its prospect beat placebo at boosting cognition in 91 patients. It hopes to kick off a phase 3 trial in late 2021. read more By Amirah Al Idrus Launched in 2015 to tackle hearing loss broadly, Decibel Therapeutics kicked off 2020 with a new CEO and an R&D makeover. Now it’s grabbing $82 million to propel its lead programs, including a gene therapy for children with congenital deafness and a program left over from its early days designed to protect hearing in cancer patients undergoing chemotherapy. read more By Ben Adams RemeGen has raised $515 million on the Hong Kong exchange in one of the largest biotech IPOs ever produced. read more By Eric Sagonowsky President-elect Joe Biden unveiled his COVID-19 transition task force Monday, with Vivek Murthy, David Kessler and Marcella Nunez-Smith co-chairing—and some other bold-faced names in the infectious disease world serving on the panel. First order of business: Working with state and local officials to determine conditions around the country as case counts surge. read more By Conor Hale A low-cost, rapid coronavirus diagnostic developed by researchers at the University of Oxford is now in place to screen passengers at major international airports in London and Hong Kong. read more By Arlene Weintraub Researchers at Boston Children’s Hospital engineered an antibody-drug conjugate to home in on pancreatic tumors and deliver a cancer-killing compound to them. Two doses of the drug shrank tumors and prevented metastasis in mouse models of the disease. read more Resources 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: WCG Need additional site resources for your current or upcoming clinical trial? 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: Veeva Learn how to plan immersive digital event experiences 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: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper 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: Cascade Chemistry, API CDMO Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success. 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. Learn How To Bring A Drug Successfully To Market Oct 21-22, 2020 | Live, Online Drug Development Immersion: Live, Online Course October 21-22, 2020 | 9am - 3:30pm ET Become Fluent In Drug Development With Our Industry Expert October 21-22, 2020 | 9am - 3:30pm ET BioBasics 101: The Biology of Biotech for the Non-Scientist: Live, Online Course November 12-13, 2020 | 9am - 3:30pm ET Drug Development Boot Camp® VIRTUAL 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now | Due to COVID19 provisions – training will be conducted VIRTUALLY | Same excellent total immersion training in new medicine development will be made available to experts who want to make a difference to patients. |