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STAT+: Pharmalittle: We’re reading about Bavarian Nordic’s mpox shot, a crackdown on Ozempic prescribing and more

STAT

Or if you prefer to enjoy the great indoors, you could curl up with a good book or binge watch moving pictures on the telly. One doctor said he thinks the company wants to discourage using the drugs for unapproved purposes, a practice called off-label prescribing, which is legal and accepted in American medicine. But be safe.

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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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6 Digital Tools at the Center of Healthcare Digitalization [INFOGRAPHIC]

Pharma Marketing Network

Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *. The post 6 Digital Tools at the Center of Healthcare Digitalization [INFOGRAPHIC] appeared first on Pharma Marketing Network.

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How Label Management Solutions Can Help CDMOS Grow Their In-House Capabilities

pharmaphorum

BRINGING IT ALL HOME: HOW LABEL MANAGEMENT SOLUTIONS. In this blog, PRISYM ID’s Clinical Trials Sales Manager Bob Bowdish looks at the challenges of in-sourcing label management processes for CDMOs, and explores how they can be overcome by investing in a cloud-based, validation-ready labeling solution. Stick or twist?

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EU gives narrower label to Apellis, Sobi’s PNH drug

pharmaphorum

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.

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Digital Tools at the Center of Healthcare Digitalization

Pharma Marketing Network

Get your complimentary copy of "The Publishing Industry: The Soar of Innovation During COVID-19 Fact Sheet". Company Email *. The post Digital Tools at the Center of Healthcare Digitalization appeared first on Pharma Marketing Network.