Data for Biogen's Alzheimer's hopeful aducanumab 'highly persuasive': FDA briefing documents Trial chief tips AstraZeneca COVID-19 vaccine for 2020 data drop Fosun follows BioNTech in changing COVID-19 vaccine, plans bridging study for Chinese filing Sponsored: Best Practices for Research Sites: Effectively Using Patient Recruitment Advertising Dollars JW Therapeutics rakes in $300M Hong Kong IPO to bring CAR-Ts to China BioMarin nabs FDA review for dwarfism drug vosoritide, forgoes AdComm as it eyes 2021 approval Inhibikase Therapeutics slahes deal size ahead of IPO FDA greenlights Boston Scientific's paclitaxel-coated Ranger balloon for peripheral artery disease Featured Story | By Ben Adams A drug that was very nearly culled and needed some serious data digging to find glimmers of efficacy has been broadly backed as “highly persuasive” from the FDA’s briefing documents out Wednesday morning. read more |
| |
|---|
|
| | For oncology CROs, the utilization of noninvasive optical imaging gives researchers an earlier indication of anti-cancer activity and valuable insight into the effects of new drugs. Our free white paper details its benefits and how this method can advance your drug program. Read more! |
Top Stories By Nick Paul Taylor AstraZeneca has a good chance of delivering late-phase data on its COVID-19 vaccine this year, the chief investigator of the Oxford Vaccine Trial said. The timing gives AstraZeneca a “small chance” of being able to start distributing the AZD1222 vaccine in the U.K. before Christmas. read more By Nick Paul Taylor Fosun Pharma has stopped development of BioNTech’s first COVID-19 vaccine, following the lead of its German partner by picking BNT162b2 as the candidate to take to market. read more Sponsored 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 As it gears up to launch a new CAR-T therapy in China, JW Therapeutics pulled off a $300 million (HK$2.325 billion) IPO on the Hong Kong Stock Exchange. The bulk of the funds will bankroll R&D and commercialization for its lead program, while the rest will fund the company’s earlier-stage programs. read more By Ben Adams The FDA will hand down a decision on BioMarin’s rare disease drug vosoritide by Aug. 21 as it says there's no need for an advisory committee. read more By Ben Adams Twelve-year-old early-stage neuro biotech Inhibikase Therapeutics has nearly halved its shares offering ahead of a now lowered IPO. read more By Conor Hale Boston Scientific has secured FDA approval for its Ranger paclitaxel-coated balloon, designed to help limit a patient’s systemic exposure to the chemotherapy used to slow the closure of reopened arteries. read more Resources 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: WCG Need additional site resources for your current or upcoming clinical trial? Sponsored By: AmerisourceBergen How pharma's supply chain partners are paving the way for coronavirus therapies. 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 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. 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 Learn How To Bring A Drug Successfully To Market Oct 21-22, 2020 | Live, Online 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. | 