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STAT+: Merck strikes voluntary licensing deals in poor countries for an experimental HIV prevention pill
Amid rising concern over efforts to contain HIV, Merck has reached voluntary licensing deals with seven companies to make generic versions of an experimental, once-a-month prevention pill in 129 low- and middle-income countries.
The agreements will allow the manufacturers — three of which are based in Africa and four in India — to sell generic versions to both public and private buyers, which is designed to ensure the medicine becomes available to the widest possible population. Moreover, the deals are royalty free, which makes it easier for the generic companies to predict costs.
The timing of the announcement is notable because Merck is striking these deals while its medicine, known as alimatravir, is currently undergoing a pair of late-stage clinical trials. By doing so now, the company believes it will help the generic makers plan for wide-scale production and the necessary steps to receive regulatory approvals around the world.
Amid rising concern over efforts to contain HIV, Merck has reached voluntary licensing deals with seven companies to make generic versions of an experimental, once-a-month prevention pill in 129 low- and middle-income countries.
The agreements will allow the manufacturers — three of which are based in Africa and four in India — to sell generic versions to both public and private buyers, which is designed to ensure the medicine becomes available to the widest possible population. Moreover, the deals are royalty free, which makes it easier for the generic companies to predict costs.
The timing of the announcement is notable because Merck is striking these deals while its medicine, known as alimatravir, is currently undergoing a pair of late-stage clinical trials. By doing so now, the company believes it will help the generic makers plan for wide-scale production and the necessary steps to receive regulatory approvals around the world.
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Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity
Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity
As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market. Read More
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.
The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals’ antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling—and readjusting. BioSpace looks at five contenders and where they currently stand.
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