- Intellia hits a 'home run' with gene editing results, setting up entire field for a grand slam
- Sanofi commits $476M a year to mRNA vaccine center in race to expand tech beyond COVID-19
- After Orphazyme's pipeline in a product bursts, the inevitable tide turns on its staffers
- Sponsored: The Far-Reaching Value of Deeply Understanding the Patient Journey
- Foresite’s 2nd SPAC deal counts Gilead as an investor in $276M bid for COVID-19 biotech Pardes
- ADA 2021: Hanmi's GLP-1 drug, returned by Sanofi, curbs cardiovascular, kidney issues while tackling Type 2 diabetes
- Cel-Sci's 11-year cancer drug odyssey ends in failure, sinking stock, but plots FDA filing anyway
- Outsmarting cancer with RNA, 'genome-tuning' drugs and other gene-altering therapies
- 4G Clinical raises $230M to expand its RTSM global reach, product capabilities
- Pfizer, CDC experts don't see eye to eye on COVID-19 boosters, threatening key revenue stream: analysts
Featured Story | By Annalee Armstrong Intellia’s gene editing results “decisively exceeded” analyst expectations, launching the rest of the field into the spotlight overnight and maybe, just maybe, providing some fodder for the FDA to lighten up on its resistance to hosting gene editing trials in the U.S. Shares of the Cambridge, Massachusetts-based biotech gained more than 55% Monday, rising to $133.43 at close. read more |
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Top Stories By Nick Paul Taylor Sanofi is set to invest €400 million ($476 million) a year in a dedicated vaccines mRNA Center of Excellence. The commitment is intended to establish Sanofi as a frontrunner in the race to develop mRNA vaccines against a wide range of infectious diseases. read more By Ben Adams Orphazyme is taking the ax to most of its workforce after its beleaguered single asset has been hit by rejections and serial flops in the clinic. read more Sponsored by: Alexion An experiential learning program where Alexion employees “walk in the shoes” of patients to deepen understanding of the rare disease journey and develop impactful solutions. Learn more about LEAP. read more By Amirah Al Idrus Foresite Capital’s second special purpose acquisition company (SPAC) has landed on its target: Pardes Biosciences, a biotech working on antiviral treatments for COVID-19. Through the merger, Pardes will add about $276 million to the bank, which will get its lead candidate into the clinic later this year. read more By Amirah Al Idrus Hanmi Pharmaceuticals may no longer have a diabetes partner in Sanofi, but newly released results for its GLP-1 drug could move the needle for Type 2 diabetes patients with a history of cardiovascular disease, kidney disease or both. Efpeglenatide reduced the risk of heart attack, stroke and death and also slowed decline in patients’ kidney function, new data show. read more By Nick Paul Taylor A phase 3 clinical trial of Cel-Sci’s immunotherapy candidate has missed its primary endpoint. The drug failed to improve on the overall survival achieved by standard of care in the overall population of head and neck cancer patients, but Cel-Sci plans to seek FDA approval on the basis of a subgroup analysis. read more By Arlene Weintraub Startups and academics are working on novel treatments designed to turn the expression of certain genes up or down to achieve an anti-cancer effect. It’s not gene therapy in the traditional sense, because they’re not replacing disease-causing genes, but if they succeed, they could offer new ways to conquer "undruggable" cancer targets. read more By Kyle LaHucik The randomization and trial supply management system provider will use the investment to expand its reach in the Asia Pacific region and add capabilities to its natural language processing technology stack. read more By Noah Higgins-Dunn Pfizer has predicted that a COVID-19 vaccine booster could be needed as soon as antibody blood concentration wanes to ensure the broad population can't carry the virus, Bernstein analysts wrote in a recent note. However, a key CDC panel doesn't appear to agree. read more |  | Health Care Is Home Care From study drug administration to blood draws, Marken’s fully integrated home healthcare solutions make participation in clinical research as simple as possible for patients. Learn more. |
Resources Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: PA Consulting What does the future of Cell & Gene Therapy look like? Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. Sponsored by SDG Group Discover how Ashfield Healthcare uses the power of data and analytics to enable pre-call planning, inform sales rep actions and drive higher market share for its target pharmaceutical products. Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 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 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. | 
