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 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 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 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 ...
Posted by Michael Wonder on 20 Aug 2022
Kapruvia approved in Switzerland with additional regulatory decisions expected in H2, 2022
19 August 2022 - Regulatory decisions in Australia and Singapore expected by the end of 2022. ...
Posted by Michael Wonder on 08 Jun 2022
BioCryst announces approval of Orladeyo (berotralstat) by Swissmedic
7 June 2022 - -- BioCryst Pharmaceuticals today announced that Swissmedic has granted marketing authorisation for oral, once-daily Orladeyo (berotralstat) ...
Posted by Michael Wonder on 31 May 2022
Swiss drug prices still soar above European levels
31 May 2022 - Compared with nine other European countries, Switzerland remains a high-price island for medicines, according to an annual ...
Posted by Michael Wonder on 14 May 2022
Hansa Biopharma announces temporary marketing authorisation in Switzerland for Idefirix (imlifidase) in kidney transplantation
13 May 2022 - Idefirix is now granted marketing authorisation within the EU, the U.K., Israel and Switzerland. ...
Posted by Michael Wonder on 26 Apr 2022
Swissmedic has accepted the new oral edarvarone formulation for the treatment of ALS
25 April 2022 - Mitsubishi Tanabe Pharma announced that Swissmedic has accepted the filing for an investigational oral suspension formalation ...
Posted by Michael Wonder on 23 Mar 2022
MorphoSys and Incyte announce Swissmedic temporary approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with r/r DLBCL
22 March 2022 - Minjuvi is a new therapeutic option for eligible DLBCL patients in Switzerland addressing an urgent unmet medical ...
Posted by Michael Wonder on 19 Feb 2022
BeiGene announces approval for Brukinsa (zanubrutinib) by Swissmedic for treatment of adult patients with Waldenström’s macroglobulinaemia
17 February 2022 - With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global ...
Posted by Michael Wonder on 17 Jan 2022
Swissmedic grants temporary authorisation to Xevudy for COVID-19 patients
14 January 2022 - Corona medication Xevudy from GSK (sotrovimab) granted temporary authorisation in Switzerland ...