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Latest From Alkermes plc
Can US FDA Share Drug Sponsor’s Information With Patent & Trademark Office?
Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.
Trials In Focus: How COVID-19 Studies Set New Standards For Collaboration, Diversity
JAMA reports on the COVID-19 Prevention Network’s efforts. Also, Inhibikase said the US FDA lifted a hold on its drug for Parkinson’s disease, while Astellas Pharma said the agency lifted a clinical hold on its gene therapy for Pompe disease. And Trefoil, Theriva Biologics and Nektar initiated new trials.
Requests For EMA PRIME Designation Fall But Improvements Are On The Way
While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.
10 Clinical Trials To Watch Out For In 2023
Scrip surveys the Phase III clinical trial readout landscape and picks 10 of the more interesting studies set to report in 2023, with a few added extras. AstraZeneca, Novo Nordisk, Novartis and Roche feature heavily.
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