Project Orbis: quicker access to promising cancer treatments

29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...

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Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis

13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...

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Curium announces submission of the marketing authorisation application for Pylclari, an innovative (18F)-PSMA PET tracer indicated in adults with prostate cancer to Swissmedic

22 February 2024 - Curium announced today that the marketing authorisation application for Pylclari (piflufolastat (18F)) submitted by exclusive Swiss ...

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Swissmedic approves Beyfortus for RSV prophylaxis in newborns, infants and young children

28 December 2023 - Following a thorough review, Swissmedic has authorised the medicinal product Beyfortus from marketing authorisation holder Sanofi-Aventis (Suisse). ...

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Application for COVID-19 vaccine Nuvaxovid against Omicron variant XBB.1.5 withdrawn

18 December 2023 - The manufacturer Novavax is no longer pursuing marketing authorisation for its COVID-19 vaccine in Switzerland. ...

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Orchard Therapeutics receives Swissmedic approval for Libmeldy in early-onset MLD

11 December 2023 - Orchard Therapeutics today announced the Swiss Agency for Therapeutic Products (Swissmedic) has approved Libmeldy (atidarsagene autotemcel), a ...

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Switzerland restricts reimbursement of orphan drugs

30 October 2023 - New rules for the reimbursement of orphan drugs and other unlisted medicines will become effective in Switzerland ...

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Swissmedic approves Moderna coronavirus vaccine Spikevax XBB.1.5

28 September 2023 - Spikevax XBB.1.5 approved for persons aged 18 and over ...

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Regulatory challenges: is a surrogate endpoint instead of overall survival enough for regulatory approval of (neo)adjuvant cancer treatment? The Swissmedic perspective.

21 September 2023 - From a regulator's point of view, a market authorisation can only be granted with a positive benefit-risk ...

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Swiss drug review times trail FDA and EMA, increased due to COVID

21 August 2023 - While lagging other regulators in bringing new drugs to market, Swiss regulators say their review times ...

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Moderna submits authorisation application for coronavirus vaccine Spikevax XBB.1.5

13 July  2023 - Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5 ...

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Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345

5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...

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Akebia announces Swissmedic approval of Vafseo (vadadustat)

20 June 2023 - Akebia Therapeutics today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorisation ...

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Swiss drug prices still much higher than abroad

19 May 2023 - Patent-protected medicines cost an average 5.4% less in other European countries than in Switzerland, and 10.8% ...

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Aurinia Pharmaceuticals announces Swissmedic approval of Lupkynis (voclosporin)

2 May 2023 - Aurinia Pharmaceuticals today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization of ...

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