Blog
RSS FeedPosted 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 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. ...
Posted by Michael Wonder on 25 Jan 2023
Pricing of medicines in Switzerland | Three yearly price review: What are the most important changes for 2023?
24 January 2023 - The Federal Office of Public Health reviews the price of every medicinal product that is reimbursed under ...
Posted by Michael Wonder on 06 Dec 2022
Swissmedic approves Quviviq (daridorexant) – a first in class treatment for chronic insomnia disorder to improve both nighttime symptoms and daytime functioning
5 December 2022 - Quviviq, Switzerland's first approved dual orexin receptor antagonist, offers a new targeted mechanism of action that decreases ...
Posted by Michael Wonder on 03 Dec 2022
Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)
1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...
Posted by Michael Wonder on 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...
Posted by Michael Wonder on 21 Nov 2022
Moderna applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine
18 November 2022 - Application submitted for Spikevax Bivalent Original / Omicron BA.4-5 (mRNA-1273.222) ...
Posted by Michael Wonder on 11 Oct 2022
Swiss drugs regulator approves one of Pfizer's COVID-19 booster shots
10 October 2022 - Swiss drugs regulator Swissmedic said on Monday it had temporarily approved Pfizer's COVID-19 booster shot targeting ...
Posted by Michael Wonder on 23 Sep 2022
Pfizer applies to Swissmedic for authorisation of another COVID-19 vaccine
22 September 2022 - Pfizer said on Thursday it had submitted an application to Swissmedic for authorisation of a further ...
Posted by Michael Wonder on 17 Sep 2022
Swiss regulator gives green light to first drug to prevent Covid-19
16 September 2022 - Swissmedic has issued a temporary marketing authorisation for AstraZeneca’s drug Evusheld, making it the first Covid-19 prophylaxis ...