Spotlight

USP is exploring how its extensive expertise in developing quality standards for drug products and ingredients can contribute to pharmaceutical continuous manufacturing.

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PHARMA TECH

Saama Launches Active Safety Analytics for Pharma (ASAP), Co-built With Gilead to Transform Safety Surveillance

Saama Technologies, Inc. | October 27, 2020

Saama Technologies, Inc. (“Saama”), the AI clinical analytics platform company, announced today the launch of the new Active Safety Analytics for Pharma (ASAP) product. ASAP is the first validated pharmacovigilance solution to leverage the U.S. Food and Drug Administration’s (FDA) Sentinel Common Data Model and the TreeScan methodology for detecting safety signals. ASAP was co-built with Gilead Sciences, a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Saama and Gilead partnered to develop ASAP, with scientific advice from the Reagan-Udall Foundation for the FDA, and accelerate the life sciences industry’s paradigm shift to adopt active safety analytics.

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RESEARCH

UConn startup DIANT bags license for continuous nanoparticle manufacturing tech

UConn | November 20, 2020

Consistent assembling has just begun to override customary group handling in the domain of tablet creation. The following region due for an assembling update? Nanoparticle drug conveyance frameworks, one startup thinks—and it's currently prepared to pitch its foundation to drugmakers. The University of Connecticut as of late authorized its ceaseless nanoparticle fabricating innovation to DIANT Pharma, a startup helped to establish by the stage's designers Antonio Costa, Ph.D., and Diane Burgess, Ph.D. The high-throughput framework can possibly spare tidy up room space, bring down the quantity of preparing steps and diminish the quantity of bunches created every year. Since the stage is persistent, it should empower makers to hop in the event that anything turns out badly, redirecting or eliminating just a little bit of the item instead of rejecting a whole group, Costa, CEO at DIANT and partner research teacher at UConn, said in a meeting.

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RESEARCH

Pluristem Enters Collaboration With Pharmaceutical Company Innovare R&D to Expand Pluristem’s ARDS Associated With COVID-19 Program to Mexico

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."

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Spotlight

USP is exploring how its extensive expertise in developing quality standards for drug products and ingredients can contribute to pharmaceutical continuous manufacturing.