Pluristem | December 30, 2020
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a main regenerative medication organization building up a foundation of novel natural helpful items, reported today it has gone into a coordinated effort concurrence with Mexican drug organization Innovare R&D to extend its continuous clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) related with COVID-19 in Mexico. The Phase II investigation in Mexico is dependent upon the endorsement of neighborhood specialists, with the objective of being led under the U.S. Food and Drug Administration (FDA) cleared convention.
As per the arrangement, Innovare will open clinical destinations and enlist patients for the proposed clinical investigation in Mexico. Innovare will subsidize the examination in Mexico and will buy PLX cells for the investigation from Pluristem. Subject to potential positive clinical investigation results and Mexican administrative endorsement for commercialization, the arrangement awards Innovare restrictive conveyance rights in Mexico to supply PLX cells for treating serious COVID-19 cases confounded by ARDS. All protected innovation and assembling rights stay with Pluristem.
With 1,389,430 cases and 122,855 passings as of December 29, 2020, Mexico's COVID-19 disease and death rates have been expanding. Mexico has the most elevated passings relatively to COVID-19 cases or populace on the planet as of December 28, 2020, as announced by Johns Hopkins University of Medicine.
"We are satisfied to unite with Innovare, a main imaginative organization intending to be important for the answer for battling the COVID-19 pandemic in Mexico," expressed Pluristem CEO and President, Yaky Yanay. "On account of our key upper hand of having in-house producing office, progressed strategic capacities, and a worldwide reach, we can supply PLX cells to clinical bases on the world while broadening our worldwide help for COVID-19 into Latin America. By directing the examination in both the U.S. furthermore, Mexico, in corresponding to the E.U. furthermore, Israel, we are proceeding with our attention on accomplishing clinical achievements and targets, while bringing the expected treatment of PLX cells to those out of luck."
Gerardo Cárdenas Vogel, CEO of Innovare R&D remarked, "As an organization that is looking for overall accomplices indicating clinical guarantee for neglected clinical necessities, we are eager to team up with Pluristem. We anticipate utilizing our clinical and business capacities with Pluristem's high level cell treatment answer for help create and possibly bring a genuinely necessary treatment for ARDS patients related with COVID-19 to Mexico."
Sanofi | November 17, 2020
When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant.
The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at the contractor's site, the French drugmaker said Friday.
A Sanofi spokeswoman declined to specify who the manufacturer cited in the FDA's letter was or what the nature of the deficiencies were.
With its application on hold, Sanofi said it would work with its manufacturer and the FDA to resolve the issues in a "timely manner." The drugmaker didn't say how quickly it expected to turn around a new application.
The untimely feedback from the FDA dims C1 inhibitor sutimlimab's chances in cold agglutinin disease (CAD), a rare blood disease characterized by anemia, fatigue and other symptoms.
Corval | September 22, 2021
Corval LLC announced the launch of its cloud-based commercialization planning platform designed for early- to mid-stage biopharma companies. Created by industry veterans with deep experience in biopharma commercialization, the platform provides a technology-based approach that expedites the commercialization planning process and helps teams align on strategic decisions, timing, and future resourcing needs.
I have spent my entire career in this space and been exposed to the many challenges facing early- to mid-stage biopharma companies, particularly, how the lack of in-house expertise and constrained resources can threaten the ability to know what to do when.
- Sue Nemetz, founder and CEO of Corval and CEO of The NemetzGroup LLC, a strategic consultancy that has supported the progression of more than 100 companies with assets at every phase of development.
As a biotech CEO and investor, I have seen many companies get mired in the commercialization planning process. Corval, built upon the wealth of knowledge and experience from The NemetzGroup, will help ensure biotech executive teams don't miss any critical steps on their path to market.
- Abbie Celniker, Ph.D., a Partner at Third Rock Ventures.
Corval's platform is built upon decades of biopharma commercialization experience and more than 75,000 data points that drive recommendations throughout the entire development timeline and accommodate the unique circumstances of each asset's commercial strategy. Corval contains foundational tools for commercialization success, including:
Custom Commercialization Map: a detailed and adaptable roadmap of the objectives and activities necessary to commercialize an asset
Budget and Resource Plan: a customized schedule of the resources and investments required to support these activities and achieve organizational objectives
Commercialization Center: a single workspace to collaborate on the roadmap and access a trove of commercialization knowledge
Corval develops technology solutions to empower biopharma leaders to navigate the commercialization process with confidence. Built on decades of commercialization expertise, its innovative cloud-based platform assesses each asset's unique situation and creates a customized, detailed map to illustrate every step on the journey from clinic to market. Corval reduces the commercialization planning process from three to six months to three to six days, dramatically streamlining efforts to set commercialization plans in motion.