Johnson & Johnson and Legend Biotech have filed an application in Europe to move Carvykti up the treatment line. Thermo Fisher has opened a new facility in Singapore. Celltrion's Humira biosimilar has finally won an FDA approval after a manufacturing problem delayed the review. And more.
1. Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma
Johnson & Johnson and Legend Biotech have filed Carvykti in Europe for earlier treatment of multiple myeloma. The application uses data from the CARTITUDE-4 trial. According to leaked results from the study that were later confirmed by Legend, Carvykti cut the risk of progression or death by 74% against standard combo treatment in patients who had tried one to three prior lines of therapy.
2. Amid biopharma's Singapore expansion push, Thermo Fisher debuts sterile drug facility
Thermo Fisher Scientific has opened a new sterile drug plant in Singapore to support delivery of vaccines and medicines for the region. The plant includes a high-speed, fully automated aseptic fill-finish line for both small and large molecules. Other drug manufacturers including Merck & Co., Sanofi, WuXi Biologics and GSK have recently expanded in Singapore.
3. Celltrion wins FDA nod for Humira biosimilar after delay
Celltrion has won FDA approval for Yuflyma, a high-concentration formulation of a biosimilar to AbbVie’s Humira. Yuflyma marks the company’s fifth biosimilar approved in the U.S. The decision came late because Celltrion had to resolve a problem uncovered during an FDA manufacturing inspection, Korea Biomedical Review reported in February.
Meanwhile, Celltrion and patient organization the European Federation of Crohn’s and Ulcerative Colitis Associations launched a new campaign for inflammatory bowel disease (IBD). The new campaign asks, where’s colitis and Crohn’s (CC), featuring hidden CC characters based on real-life patient stories. With Yuflyma and a biosimilar to J&J’s Remicade, Celltrion has two TNF blockers for IBD.
Zoll Medical entered into a $400,000 settlement with the U.S. Department of Justice over claims that the devicemaker violated the Trade Agreements Act of 1979 when it sold the U.S. government ECG cables made in China. The law mandates that goods sold to the U.S. government must be manufactured only in the U.S. and 126 other nations.
6. Dr. Reddy's CDMO subsidiary Aurigene plans $40M expansion in India
Aurigene Pharmaceutical Services will spend $40 million to build a production facility for therapeutic proteins, antibodies and viral vectors in Hyderabad, India. The Dr. Reddy’s Laboratories subsidiary said it expects to start operating at the facility by the first half of 2024.