regulation

FDA’s use of real-world data

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The 21st Century Cures Act required the Food and Drug Administration (FDA) establish a program for evaluating the use of real-world data (RWD) to support the approval of new indications for drugs. Real-world data is typically data from either health insurance claims, electronic health records… Read More »FDA’s use of real-world data

Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020

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SMi reports: Alan Franklin, CEO, ForwardVue Pharma will be presenting at the Ophthalmic Drugs conference The 4th Annual Ophthalmic Drugs Conference taking place on the 23rd -24th November 2020, will explore new discoveries in the treatment of ocular disease, innovations in combination technologies, and the… Read More »Exclusive interview with ForwardVue Pharma released for Ophthalmic Drugs 2020

UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran

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The UK’s regulator has granted early access to Alnylam’s ultra-rare disease drug lumasiran, allowing patients with primary hyperoxaluria type 1 to gain access ahead of a regulatory decision by the European Commission.  The Medicines and Healthcare products Regulatory Agency (MHRA) gave a positive opinion for lumasiran through its… Read More »UK patients get early access to Alnylam’s ultra-rare disease drug lumasiran