Regulatory Affairs Associates

The guardian | May 03, 2020

Swiss drug maker Roche Holding AG says it has received emergency use approval from the US Food and Drug Administration (FDA) for an antibody test to help determine if people have ever been infected with the coronavirus. Governments, businesses and individuals are seeking such blood tests to help them learn more about who may have had the disease, who may have some immunity and to potentially craft strategies to end lockdowns that have battered global economies. Roche had previously pledged to ma...

Research

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 neighb...

Business Insights, PHARMA TECH

Dalton Pharma Services | February 17, 2023

On February 16, 2023, Dalton Pharma Services, a leading cGMP pharmaceutical firm, announced a significant strategic expansion of its sterile filling and pharmaceutical manufacturing capabilities. The capital expansion plan includes a brand-new, state-of-the-art, and fully automated cGMP sterile filling line that can fill syringes, vials and cartridges under isolator technology. The sterile fill line is integrated with a new cGMP lyophilizer to provide customers with complete sterile finish...

Prnewswire | September 30, 2020

In a bid to improve the quality and availability of information on health-specific cannabis use, industry giant WayofLeaf.com has introduced a team of doctors and health experts to review thousands of topics relating to the use of medical cannabis and CBD for specific health conditions. The website, which for years has provided a reliable informational resource for medical cannabis patients, believes it is time for cannabis users of all types to have access to trustworthy, research-backed conten...