The US House Committee on China has requested a briefing from the FBI and the intelligence community regarding GenScript Biotechnology Co and its three subsidiaries: Bestzyme, Legend Biotech, and ProBio. Lawmakers are seeking to determine if the Chinese Communist Party (CCP) has any influence over the operations of these companies. This request comes two weeks after another House committee approved a bill that would restrict business with several Chinese biotech firms, including WuXi AppTec, WuXi Biologics, BGI, MGI, and Complete Genomics, due to concerns over national security and the protection of sensitive healthcare data. The lawmakers' interest in GenScript Biotech reflects the ongoing scrutiny of Chinese biotech companies and their potential ties to the CCP. [94307902]
In a separate development, three top American lawmakers, Cathy McMorris Rodgers, Brett Guthrie, and Morgan Griffith, have raised concerns about the FDA's foreign drug inspection program in India and China. They have written a letter to FDA Commissioner Robert Califf, highlighting inconsistencies in inspection outcomes from January 2014 to April 2024. The lawmakers are calling for an investigation into the skill and thoroughness of FDA inspectors to ensure rigorous and consistent inspections. This development adds to the growing concerns over the safety and quality of drugs imported from India and China. [730ff334]
In another news, the U.S. Food and Drug Administration (FDA) has inspected Divi's Laboratories Ltd.'s manufacturing facility in Visakhapatnam, Andhra Pradesh. The inspection took place from July 11-19, and the FDA made one procedural observation. Divi's Laboratories is a Hyderabad-based drugmaker that produces active pharmaceutical ingredients and intermediates for global markets. The company did not provide details about the observation made by the FDA. Shares of Divi's Laboratories closed 1.48% lower after the announcement. [8a8ef229]
Meanwhile, the United States Food and Drug Administration conducted a surprise inspection on Gland Pharma's Dundigal Facility in Hyderabad for Good Manufacturing Practices from July 22 to July 25. The inspection concluded with two 483 Observations, which are procedural in nature. Gland Pharma stated that the observations are neither repeated nor related to data integrity. Gland Pharma also received tentative US FDA approval for Latanoprostene Bunod Ophthalmic Solution, 0.025% on July 23. The stock of Gland Pharma Ltd. rose by 0.71% during the day. [616f04dc]
Cipla, a leading Indian pharmaceutical company, expects to start supplying the US market from its China facility in the second half of FY 2024-25. The company has received approval from the USFDA and is working to resolve issues with its domestic plants. The China facility has cleared the USFDA audit, along with the Patalganga and Kurkumbh plants in India. However, the Goa site has received observations, and the Indore plant is being remediated. Cipla is focusing on new therapeutic areas, investing in tech-based solutions, and addressing antimicrobial resistance. The company also plans to develop drugs, digital initiatives, nutraceuticals, and the overall ecosystem for obesity and obesity-related diseases. Additionally, Cipla is investing in new-age tech-based solutions like CAR-T cell therapy, peptides, oligonucleotides, and biosimilars. The company aims to enhance its digital initiatives and invest in big brands, strategic alliances, and global partnerships to democratize healthcare services. [16e7bdbe]