14 September 2023
14 September 2023
Companies that include Walgreens Boots Alliance and CVS have received warning letters from the FDA.
ICON will conduct Phase IIb clinical trials for the US BARDA-selected Covid-19 vaccine candidates as part of Project NextGen.
The company is seeking approval for resmetirom to treat NASH and liver fibrosis under the FDA’s accelerated approval pathway.
Roche planned to launch the new formulation this year, but it will be pushed back after tweaks requested by FDA.
The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.
The company will divest the AVTX-800 rare disease compound series to AUG Therapeutics, with an expected completion in Q4 2023.
AbCellera will receive research payments, downstream clinical and regulatory milestone payments and royalties for net product sales from Incyte.
Sun Pharma will make upfront, milestone and royalty payments to Pharmazz under the agreement.
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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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