Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s ARCoV had acceptable safety and induced a strong immune response, partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine.
North China Pharmaceutical Group New Drug Research & Development Co. Ltd. has received approval from China’s NMPA to market ormutivimab as post-exposure treatment for the prevention of rabies.
Edigene Inc. has extended a long-running partnership with an academic lab at the Chinese Academy of Medical Sciences and Peking Union Medical College with the goal of co-developing hematopoietic stem cell regenerative therapies and technology.
North China Pharmaceutical Group New Drug Research & Development Co. Ltd. has received approval from China’s NMPA to market ormutivimab as post-exposure treatment for the prevention of rabies.
With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s mRNA COVID-19 vaccine candidate ARCoV had acceptable safety and induced a strong immune response in the 120 people who received it, company partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine. If successful, the program could become the first of several Chinese-developed mRNA vaccines poised to take on the pandemic.
Edigene Inc. has extended a long-running partnership with an academic lab at the Chinese Academy of Medical Sciences and Peking Union Medical College with the goal of co-developing hematopoietic stem cell regenerative therapies and technology for the treatment of inherited blood disorders, as well as the discovery of biomarkers to improve quality control of stem cell production.
Innovent Biologics Inc. has secured an option to license China rights for up to three enzyme specific inhibitors for inflammatory disorders with few or no treatments from Amagma Therapeutics Inc. Innovent will also manufacture the inhibitors for a phase II trial in the region.
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