The Pharmaceutical Managers Institute

Business Insights

Lexitas and QHP Capital | July 08, 2022

QHP Capital the management company for NovaQuest Private Equity announced its acquisition of Lexitas Pharma Services a full-service ophthalmology contract research organization supporting biopharmaceutical and medical device clinical trials. Since 2011, Lexitas has provided clinical trial and medical strategy solutions to biopharmaceutical and medical device companies developing ophthalmic products. The Company provides end-to-end support and development expertise in the ant...

Business Insights

Oramed Pharmaceuticals Inc. | March 17, 2022

Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis. An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Dige...

Fiercepharma | June 01, 2020

Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. The COVID-19 pandemic has underscored key weaknesses in the biopharma industry’s complex global supply chain, and now a top adviser for the Trump administration is calling on Congress to push for more manufacturing in Puerto Rico. In an interview with the Washington Examiner, White House trade advis...

Business Insights

BioMarin Pharmaceutical Inc. | November 24, 2022

BioMarin Pharmaceutical Inc. announced advancements in the U.S. Food and Drug Administration review of the Biologics License Application of ROCTAVIAN™ for adults with severe hemophilia A. The Company was recently notified by the FDA that after further consideration, at this time, the Agency no longer plans to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN that is currently under review. Previously, the FDA communicated to the Company that it did intend to hold an...