Lower drug costs are just a federal license away. But they require Biden Administration leadership.

23 January 2024 - It’s a longstanding Government failure to never use federal “march-in” licensing rights to lower drug prices. It’s ...

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In ‘march-in’ rights, some see a tool to lower drug prices. Others see a threat to intellectual property.

22 January 2024 - In the fall of 2020, Robert Sachs was prescribed a medication to treat prostate cancer that had ...

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UCB announces MHRA approval for UCB’s Zilbrysq

18 January 2024 - Green light concerns generalised myasthenia gravis therapy ...

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Prescription Drug Affordability Act aims to set limits on high medication prices

17 January 2024 - Lawmakers in Springfield are focusing on high prescription drug prices. ...

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Human medicines: highlights of 2023

16 January 2024 - In 2023, EMA recommended 77 medicines for marketing authorisation.  ...

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Orphan drug label expansions: analysis of subsequent rare and common indication approvals

8 January 2024 - We found that 491 novel orphan drugs were approved between 1990 and 2022.  ...

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Novel drug approvals for 2023

8 January 2024 - Innovative drugs often mean new treatment options for patients and advances in health care for the American ...

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2023 FDA approvals

2 January 2024 - The FDA’s Center for Drug Evaluation and Research approved 55 new drugs in 2023, as the small ...

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MHRA’s new international recognition procedure goes live from 1 January 2024

2 January 2024 - In partnership with other global regulators, the international recognition procedure is expected to further help bring life-saving ...

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Biden Administration’s Medicare drug price negotiations will face major tests in 2024

28 December 2023 - US patients and drug makers will get a first glimpse of how much Medicare can negotiate down ...

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Centralised marketing authorisations of generic versions of Tecfidera are revoked by the European Commission

19 December 2023 - Biogen today announced that the European Commission has revoked the centralised marketing authorizations for generic versions ...

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Artificial intelligence workplan to guide use of AI in medicines regulation

18 December 2023 - The EMA and the Heads of Medicines Agencies have published an artificial intelligence workplan to 2028, ...

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Biden Administration to impose inflation penalties on dozens of drugs

15 December 2023 - The Biden Administration said on Thursday it had identified 48 drugs in the Medicare program whose ...

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CSL Behring’s Hemgenix granted first ever direct access in France for haemophilia B gene therapy

13 December 2023 - CSL Behring has been granted Direct Access for Hemgenix (etranacogene dezaparvovec) by the French Ministry of ...

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Apellis provides update on on-going regulatory review of pegcetacoplan for GA in the European Union

14 December 2023 - Apellis Pharmaceuticals announced today an update on the on-going review of its marketing authorisation application for ...

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