Blog
RSS FeedPosted by Michael Wonder on 14 May 2024
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 ...
Posted by Michael Wonder on 23 Feb 2024
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 ...
Posted by Michael Wonder on 28 Dec 2023
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). ...
Posted by Michael Wonder on 28 Dec 2023
Application for COVID-19 vaccine Nuvaxovid against Omicron variant XBB.1.5 withdrawn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. ...
Posted by Michael Wonder on 12 Dec 2023
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 ...
Posted by Michael Wonder on 30 Oct 2023
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 ...
Posted by Michael Wonder on 03 Oct 2023
Swissmedic approves Moderna coronavirus vaccine Spikevax XBB.1.5
28 September 2023 - Spikevax XBB.1.5 approved for persons aged 18 and over ...
Posted by Michael Wonder on 22 Sep 2023
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 ...
Posted by Michael Wonder on 22 Aug 2023
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 ...
Posted by Michael Wonder on 17 Jul 2023
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 ...
Posted by Michael Wonder on 06 Jul 2023
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, ...
Posted by Michael Wonder on 21 Jun 2023
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 ...
Posted by Michael Wonder on 19 May 2023
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% ...
Posted by Michael Wonder on 04 May 2023
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 ...
Posted by Michael Wonder on 09 Mar 2023
Swissmedic issues unlimited authorisation for booster dose of Moderna's bivalent COVID-19 Original/Omicron BA.4-5 vaccine
8 March 2023 - Spikevax bivalent Original/Omicron BA.4-5 mRNA vaccine authorised for people aged 18 and over. ...