BioNTech, Pfizer start rolling EMA approval filing for COVID-19 vaccine Amgen teases 'promising' phase 2 data for closely watched KRAS prospect Santhera flunks DMD phase 3, prompting restructuring and withdrawal of approval application Sponsored: Xevinapant’s 3-year data make waves in head and neck cancer at ESMO 2020 Walden Biosciences launches with $51M and a 2-pronged approach to 'completely transform' kidney disease Federation Bio goes live with $50M to pursue microbial treatments After ERT hit by ransomware attack, the trial company kicks out old chief amid delayed COVID-19 work Nvidia to build the U.K.'s fastest supercomputer for AI drug-hunters at GSK, AstraZeneca and more Featured Story | By Nick Paul Taylor BioNTech and Pfizer have started a rolling submission of their COVID-19 vaccine BNT162b2 to the European Medicines Agency (EMA). The news comes days after EMA named AstraZeneca's AZD1222 as the first COVID-19 vaccine to start the rolling review process. read more |
| |
|---|
|
Top Stories By Amirah Al Idrus Just two weeks after unveiling full data from its phase 1 program, Amgen’s KRAS inhibitor is back with more. The Big Biotech teased results from a phase 2 study that it says echo the efficacy seen in its closely watched phase 1 trial. read more By Nick Paul Taylor Santhera Pharmaceuticals has stopped a phase 3 trial of Duchenne muscular dystrophy (DMD) drug idebenone after it failed an interim analysis. The setback prompted Santhera to outline plans to pull a filing for approval and restructure around a second asset that it secured global rights to last month. read more Sponsored by: Debiopharm Xevinapant in combination with standard cisplatin-based chemoradiation therapy (CRT) reduces the risk of death in high-risk patients with locally advanced head and neck cancer by 50%.. This first-in-class molecule showed it could improve long-term outcomes in hard-to-treat patients, becoming the first in decades to demonstrate a survival benefit in this group. read more By Amy Sokolow In the U.S., about 37 million people live with kidney disease, which is more than 1 in 7 American adults. But Blaine McKee, the CEO of the newly unveiled Cambridge, MA, startup Walden Biosciences, hopes to change that. read more By Amirah Al Idrus Several companies are exploring microbiome treatments for various ailments, ranging from Parkinson’s disease and multiple sclerosis to more usual suspects like gastrointestinal infections. One company, Federation Bio, thinks its approach can top the rest, and its new CEO—not to mention investors—agree. read more By Ben Adams Clinical trial health tech firm eResearchTechnology is getting a new CEO in the same week a report by The New York Times said its work on COVID-19 treatments was delayed due to a cyberattack. read more By Conor Hale Through a new partnership with GlaxoSmithKline, AstraZeneca and the U.K.’s National Health Service, the chip maker Nvidia plans to build Great Britain’s most powerful supercomputer—and dedicate it to artificial intelligence research in healthcare. read more Resources Sponsored by: EVERSANA An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How. 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: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. Sponsored by: Thermo Fisher Scientific Learn how to safeguard supply, improve distribution and reduce program costs and risks Sponsored by: Clinical Ink Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol. Sponsored by: Guidehouse While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products. Sponsored by: Blue Matter Consulting Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. Sponsored by: LexisNexis Risk Solutions A complete Life Science Industry Snapshot in One Report Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. 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: 4G Clinical This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials. 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: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. 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. Medtech Innovation Week October 19-22 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. | 