AstraZeneca starts phase 1 of antibodies that could protect against COVID-19 for 6 months Tricida sinks as FDA rejection raises prospect of new trial Takeda, Ovid rare epilepsy drug slashes seizures in phase 2 Sponsored: Improve outcomes for TIL therapies by tackling process challenges AbbVie pulls the trigger on Morphic fibrosis programs, adding $20M to deal Connect Biopharma adds $115M to the pot as it eyes rivalry with Dupixent Qiagen to launch digital, portable test for COVID-19 antibodies, preordering 900K for U.S. FDA chief Hahn walks back plasma claims, but his correction still missed the point, experts say Featured Story | By Nick Paul Taylor AstraZeneca has started a phase 1 clinical trial of its two-antibody cocktail against COVID-19. The 48-subject trial is set to deliver data later this year and set AstraZeneca up to evaluate the protective and therapeutic effect of the drug in larger phase 2 and 3 studies. read more |
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Top Stories By Nick Paul Taylor The FDA has rejected Tricida’s filing for approval of a treatment for metabolic acidosis in patients with chronic kidney disease. Tricida said it may need to run another clinical trial to fix the deficiencies that led the FDA to issue the complete response letter. read more By Amirah Al Idrus Takeda and Ovid’s epilepsy drug topped placebo at reducing seizure frequency in children with rare, genetic forms of epilepsy, topline phase 2 data show. The drug performed better in Dravet syndrome than in Lennox-Gastaut syndrome, teeing up a phase 3 study in the former, while prompting the partners to dig into the data for the latter to determine its next steps. read more Sponsored By: Cytiva The efficacy of TIL therapies depends on how the original tumor samples are collected, harvested, and processed. read more By Amirah Al Idrus AbbVie has been a longtime supporter of Morphic Therapeutic, chipping into multiple venture rounds and forking over $100 million upfront in an R&D deal. Now, the Big Pharma is taking the next step: It’s paying Morphic $20 million to pick up its integrin inhibitors for the treatment of fibrotic diseases. read more By Ben Adams While Sanofi and Regeneron’s Dupixent racks up the sales, more and more biotechs want a piece of the action. read more By Conor Hale Qiagen has announced plans to launch a new digital test for COVID-19 antibodies that can run multiple samples at once on a small portable device and deliver results in about 10 minutes. read more By Eric Sagonowsky As criticism of the FDA's convalescent plasma authorization mounted Monday, Commissioner Stephen Hahn, M.D., sought to clear the air. But his defense—and his attempt to correct a misplaced statistic—didn't sit well with some experts. read more Enrollment Showcase | Presented by: Biotility Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more. |
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Resources Sponsored by: LexisNexis Risk Solutions Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information. Sponsored by: Optum Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization. Sponsored by: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment 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: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. 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: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. 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 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. | 