Blog
RSS FeedPosted by Michael Wonder on 17 Sep 2018
Dutch, Swiss regulators forge agreement on data exchange
14 September 2018 - The heads of the Netherland’s Medicines Evaluation Board and Swissmedic have signed a memorandum of understanding ...
Posted by Michael Wonder on 22 May 2018
'The Swiss government must make lifesaving drugs affordable'
22 May 2018 - Swiss health NGO Public Eye has launched a campaign calling for Swiss authorities to combat the ...
Posted by Michael Wonder on 01 May 2018
A comparative review of marketing authorisation decisions in Switzerland, the EU, and the USA
19 April 2018 - In this study we compared Swissmedic’s regulatory marketing authorisation decisions to those of the US FDA ...
Posted by Michael Wonder on 19 Apr 2018
Swissmedic validates Shire’s marketing authorisation application for investigational hereditary angioedema treatment lanadelumab
18 April 2018 - Swissmedic validation shows continued regulatory progress for lanadelumab. ...
Posted by Michael Wonder on 04 Apr 2018
Roche's Alecensa approved in Switzerland
3 April 2018 - Roche said Tuesday that its prescription medicine Alecensa has been approved in Switzerland as a first-line ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
Posted by Michael Wonder on 29 Jan 2018
Swissmedic accepts our filing for edaravone to treat ALS
23 January 2018 - Mitsubishi Tanabe Pharma Corporation announced today that the Swissmedic has accepted its filing for edaravone, an intravenous ...
Posted by Michael Wonder on 12 Jan 2018
Swissmedic updates biosimilar guidance to allow comparators of US origin
11 January 2018 - The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in ...
Posted by Michael Wonder on 06 Jan 2018
Veltassa approved for marketing in Switzerland for the treatment of hyperkalaemia
3 January 2018 - SwissMedic has approved patiromer to be marketed in Switzerland as Veltassa for the treatment of hyoperkalaemia ...
Posted by Michael Wonder on 28 Nov 2017
Ferring receives Swiss approval for Rekovelle, the first personalised fertility treatment using an approved dosing algorithm
27 November 2017 - Approval is based on a comprehensive clinical development programme (ESTHER), involving patients in 11 countries and over ...
Posted by Michael Wonder on 17 Oct 2017
Swissmedic updates requirements concerning the fast-track authorisation procedure
16 October 2017 - On 1 October 2017, the Swiss Agency for therapeutic products updated its guidance document concerning the ...
Posted by Michael Wonder on 29 Sep 2017
Roche’s Ocrevus (ocrelizumab) approved in Switzerland for primary progressive and relapsing forms of multiple sclerosis
28 September 2017 - Authorisation in Switzerland marks the first for Ocrevus in Europe following approvals in North America, South America, ...
Posted by Michael Wonder on 21 Jun 2017
Takeda and TiGenix announce that Swissmedic has accepted for review the file on Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients
19 June 2017 - Takeda and TiGenix today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has accepted for ...
Posted by Michael Wonder on 01 Jun 2017
Swissmedic touts 2016 performance: 42 new approvals
30 May 2017 - In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the EMA and ...
Posted by Michael Wonder on 31 Oct 2016
Alprolix approved in Switzerland for the treatment of haemophilia B
28 October 2016 - Alprolix approved in Switzerland for the treatment of haemophilia B ...