12 September 2023
12 September 2023
The move comes after the FDA’s VRBPAC provided guidance recommending vaccine approval.
The agreement allows Sandoz exclusive marketing rights for the inflammatory bowel disease therapy in Europe and North America.
The drug is intended for use as prophylaxis of organ rejection in allogeneic transplants of kidney, liver and heart.
Regeneron is developing an antibody for Covid-19 prevention with the help of US government funding.
The latest approval is based on data from the two-part Phase III GENESIS clinical trial.
The agency has set a PDUFA target action date of June 2024, with no current plans for an advisory meeting in the works.
The US FDA has awarded Biosyngen’s IND for the T-cell receptor therapy, BRL03, to start Phase I/II trials in lung and other solid cancers.
Shionogi will provide the key data required for the production of the antibiotic to Orchid.
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As PD therapy currently centers on symptomatic treatment, the need for DMTs is one of the greatest unmet needs. Several companies within the late-stage PD pipeline are developing drugs that target PD via novel MOAs. KOLs remain hopeful that these companies will uncover a class of drugs that works effectively to slow or modify the disease course. Targeting α-synuclein and other neurotoxic proteins is a key strategy in the late-stage pipeline for DMTs.
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