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After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi

Fierce Pharma

. | Late Tuesday, Biogen and Eisai said they kicked off a rolling FDA submission for the subcutaneous version of Leqembi—which is currently infused—after winning a fast track tag from the agency.

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STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant

STAT

Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Continue to STAT+ to read the full story…

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STAT+: CMS will use outcomes-based agreements in bid to help Medicaid pay for sickle cell gene therapies

STAT

In response to concerns over multimillion-dollar price tags for new gene therapies for sickle cell disease, the U.S. government on Tuesday announced a long-awaited “access model” designed to blunt the cost that state Medicaid programs would pay for these curative treatments. million and $3.1

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Jolly Good/Teijin Pharma develop VR digital therapeutics for depression

pharmaphorum

The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA). However Nokia famously ran into trouble when it tried to develop VR products for digital health and its OZO camera failed to catch on, mainly because of a high $60,000 price tag.

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NICE reaches a deal with Roche on access to oral SMA drug Evrysdi

pharmaphorum

The cost-effectiveness agency had turned down Evrysdi (risdiplam) in draft guidance published in June, saying it was too expensive, but after negotiations with Roche has reached a deal that will make the drug available to around 1,500 people in England. .

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3 ways pharma marketers can draw inspiration from digitally-native brands

pharmaphorum

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

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NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta

pharmaphorum

The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.

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