Genmab — Maj 2021
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Sponsors who obtain orphan designation benefit from protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market. Fee reductions are also available depending on the status of the sponsor and the type of service required. https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview
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i agree it is mainly about market exclusivity , but i do think that can be important with the rapid development of copy cats and generics. But i agree that it would only be for a small part of the market they may eventually target, as we know that they wouldn't get orphan for the whole NSCLC indication (if they decide to go for that broader label)
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Go morgen.
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Onsdagens aviser med Pandora, Jyske Bank og Huscompaniet https://www.proinvestor.com/investornyt/674730/onsdagens-aviser-med-pandora-jyske-bank-og-huscompaniet
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Yellen hverken forudså eller anbefalede renteforhøjelser - GENT https://www.proinvestor.com/investornyt/674728/yellen-hverken-forudsa-eller-anbefalede-renteforhojelser-gent
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AMG 420 was halted a while back and is followed by AMG 701. but that wasn't going flawless either: AMG 701 Enrollment in the Phase 1 study has been paused while we discuss protocol modifications to optimize safety monitoring and mitigation with the FDA. Currently enrolled patients who are demonstrating benefit may continue to receive investigational product and the Company expects to resume patient enrollment in H1 2021
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Safety and Efficacy of Daratumumab in Patients with Proliferative GN with Monoclonal Immunoglobulin Deposits https://jasn.asnjournals.org/content/32/5/1163
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