Today's Rundown Celgene refiles ozanimod with FDA 1 year after regulatory snafu iTeos brings on Sanofi cancer VP as CMO as it wades deeper into the clinic After a delay, Can-Fite digs into subpopulation data as liver cancer drug fails to hit primary endpoint Aldeyra’s anti-allergy eyedrop sails through first phase 3 trial, boosting stock price by two-thirds Arch-backed Sana bags Harvard off-the-shelf cell therapy tech Featured Story | | | Tuesday, March 26, 2019 Celgene has refiled for FDA approval of ozanimod in multiple sclerosis. The resubmission comes one year after Celgene was rocked by a refusal-to-file notice from the FDA. |
|
|
Top Stories Tuesday, March 26, 2019 Belgian immunotherapy developer iTeos Therapeutics has snagged Sanofi’s cancer drug development leader, Joanne Lager, M.D., to be its new chief medical officer. Tuesday, March 26, 2019 Israeli biotech Can-Fite missed the primary endpoint in a midstage test of its experimental late-stage liver cancer drug namodenoson. Tuesday, March 26, 2019 Aldeyra Therapeutics aced a phase 3 trial of reproxalap for allergic conjunctivitis, sending its stock up at least 66% in premarket trading. Tuesday, March 26, 2019 Sana Biotechnology has licensed technology from Harvard University to further its efforts to develop off-the-shelf cell therapies. The goal is to genetically modify and differentiate stem cells to create cell therapies that are cloaked from the immune system. | This week's sponsor is Covance. | | | Advancing a Diabetes Multi-Registration Program
Learn how Covance helped a sponsor who wanted to get all sites for a 2,700 patient study up and running as quickly as possible. Covance leveraged their proprietary historical investigator performance database to see which investigators outperformed their peers on a consistent basis and had the capacity to run multiple studies at the same time. Download the Case Study now. |
Resources Sponsored by: Veradigm Real-World case study by Veradigm suggests that new medications specifically approved for the treatment of systolic heart failure may be underutilized despite being important advances in patient care. Sponsored by: Outer Edge Technology Software end of life puts you at risk for data breaches, business disruption and liability. Support for Microsoft SQL Server 2008/2008 R2 and Windows Server 2008/2008 R2 ends on July 9, 2019 and January 14, 2020, respectively. Learn how you can turn these risks into a strategic business advantage. Sponsored by: AlphaSense From new regulations to drug pricing and the latest M&A deals, learn how AI is making it easier for competitive intelligence to uncover the insights they need to stay ahead of the curve. Sponsored by: InterSystems Analytics using patients’ real-time longitudinal laboratory results, and claims data, yielded higher value information and new revenue streams for TriCore reference laboratories. Sponsored by: InterSystems Whitepaper on leveraging normalized real-world patient data to streamline clinical trials, reduce delays and lower costs. Sponsored by: Patheon, part of Thermo Fisher Scientific The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing. Sponsored by: Patheon, part of Thermo Fisher Scientific Download this whitepaper to learn more. Sponsored by: ON24 Which HCP Touchpoints and channels are yielding the best results in today’s digital world? Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. BioBasics: Biotech For The Non-Scientist March 28-29, 2019 | Boston, MA Drug Development Immersion April 3-4, 2019 | Philadelphia, PA BioBasics: Biotech For The Non-Scientist May 8-9, 2019 | New York, NY Drug Development Immersion May 16-17, 2019 | Boston, MA 2019 BIO International Convention June 3-6, 2019 | Philadelphia, PA FierceBiotech Executive Breakfast at BIO 2019 – Getting Real: The Changing Tide on Real-World Evidence in Drug Development June 5, 2019 | Philadelphia, PA Calling Europe – Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! | 