|  | Scout Clinical helps remove the financial and logistical burdens for clinical trial participants. We offer personalized and adaptable patient payment and travel services globally. Learn more: Scout Clinical | Services! |
Featured Story | By Annalee Armstrong The pharmaceutical industry already knew virtual tools like decentralized studies, telehealth and home health visits could help make clinical trials more diverse. It just took a global pandemic to go all in on fixing the problem. read more |
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Top Stories By Ben Adams Dicerna is no longer looking to move from being a clinical- to a commercial-stage biotech as it seeks out a new partner to do the heavy lifting for the sales work for its midstage RNAi asset nedosiran. read more By Nick Paul Taylor The FDA has identified deficiencies in Axsome Therapeutics’ submission for approval of AXS-05 in major depressive disorder. With less than two weeks to go until the PDUFA action date, Axsome is yet to learn the nature of the deficiencies or their implications for its filing. read more By Annalee Armstrong Takeda is sorting through the rubble of a chaotic year in R&D to figure out what worked and what didn’t as it overcame an unprecedented disruption to business as usual due to the pandemic. read more By Annalee Armstrong The oncology team at Johnson & Johnson’s Janssen unit had to think fast to support the thousands of at-risk cancer patients in the healthcare giant’s trials as COVID-19 spread. They ended up establishing a sort of a la carte flexibility menu for clinical trial sites—and it’s going to become a permanent offering. read more By Annalee Armstrong When companies suddenly had to figure out a way to quickly take their clinical trials virtual during the pandemic, Medidata was one of their first calls. read more By Amirah Al Idrus When Takeda teamed up with Finch Therapeutics on inflammatory bowel disease (IBD), it planned to pick up programs after they’d finished phase 2 trials. Now, the Japanese pharma is moving that timeline up, taking the lead on an ulcerative colitis program before it hits the clinic. read more By Kyle LaHucik GreenLight Biosciences began its days in agriculture—think cows—and has since moved to human health to focus on, you guessed it, vaccines. Now, the ag and vax upstart is riding its way from the farm to the streets of New York City via a merger with special purpose acquisition company read more By Kyle LaHucik LQT Therapeutics will use a fresh haul of $19 million to advance its portfolio of heart disease candidates into the clinic. The Canadian biotech has in-licensed compounds from Sanofi and is working on using the SGK1 inhibitors to target Long QT Syndrome. read more By Nick Paul Taylor Visus Therapeutics has raised a further $20 million as it closes in on the release of midphase data on a potential treatment for age-related long-sightedness. The financing comes on the heels of phase 3 data on rival candidates in development at AbbVie and Eyenovia. read more By Kyle LaHucik Reify Health has raised more than 7 times the size of its August 2020 series B in another round of financing, at $220 million, to expand its decentralized research organization outside the U.S., and boost its recruitment and enrollment technology, which is available in 65 countries already. read more By Noah Higgins-Dunn Moderna is working with the Canadian government to build a “state-of-the-art messenger RNA” vaccine manufacturing facility that will help the country tackle future pandemics and provide capacity for other respiratory viruses. read more By Dave Muoio Loosened virtual care policies and the healthcare industry's growing awareness of low-income patients' needs were the pandemic's silver lining. The post-COVID middle ground being floated by policy makers would revoke those key gains, speakers at a HIMSS21 panel said. read more By Kevin Dunleavy In its second full quarter as a newly formed company, Viatris reported better-then-expected revenue. Bernstein analyst Ronny Gal, however, has doubts about its ability to sustain success in the long term. read more |  | Looking for a simple and cost-effective solution to scalable production of ESCs and iPSCs? Learn how growing pluripotent stem cells in suspension enables scaling up without scaling out while saving time and cost. Download our free PSC suspension culture infographic |
Resources Sponsored By: Patheon Pharmaceutical Services Inc. Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Evidera, a PDD business Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification 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. | 
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