Pharma companies who choose to take advantage of the EMA’s Prime scheme, which is designed to streamline and accelerate the development and approval process for priority drugs, will now be able to meet with the agency about a year before they file for approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acurx, Biosyngen, Boan, Bone, HRA, Nova Mentis, Regenxbio, Sarepta, Takeda, Telix, Vertex.
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the World Health Organization (WHO) is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions so the treatments can be used where they’re needed most.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Can-Fite, JW, Merck, Moderna, Promis, Sumitomo.
Hundreds of executives from biopharma companies are signing onto an April 10 letter decrying a U.S. district judge’s decision last week to stay the FDA approval of mifepristone, which is used in more than half of all abortions in the U.S.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Brim, CNS, Enanta, Everest, Merck.
The long-running Makena saga came to a close April 6 with the U.S. FDA announcing its decision to immediately withdraw approval of the drug and its generics – the only drugs indicated in the U.S. to reduce the risk of preterm birth.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, AB Science, Accord, Advantage, Direct, Edesa, Inflarx, Mirum, Perfuse, Soligenix, Verismo.
As the number of drug shortages continues to grow in the U.S. and globally, the FDA is issuing a draft guidance spelling out drug and API manufacturers’ responsibility to give the agency a timely, informative heads-up about changes in their production that could lead to a shortage.
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