Dynavax Technologies Corporation
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Latest From Dynavax Technologies Corporation
Taiho will pay Cullinan Oncology up to $405m for their joint venture and lead candidate for a form of lung cancer. Plus deals involving Zhaoke/Visus, AnGes/Eiger, Juniper/Helsinn, Peak Bio and more.
Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.
Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill
Draft legislation would undo the Catalyst decision prohibiting FDA from providing separate orphan exclusivity periods for different subpopulations and alter the Genus ruling by requiring FDA to treat contrast agents, radioactive drugs and OTC monograph drugs as drugs.
Axsome’s CRL was not the first from the US FDA for the nearly insoluble NSAID as sponsors try different technologies for delivering its pain relief quickly.
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