Blog
RSS FeedPosted by Michael Wonder on 25 Mar 2019
Mavenclad (cladribine tablets) approved as the first short-course oral treatment for relapsing remitting multiple sclerosis in Switzerland
25 March 2019 - Approval based on extensive clinical development program capturing more than 10,000 patient years of safety data and ...
Posted by Michael Wonder on 28 Nov 2018
Octapharma receives Swissmedic approval for fibryga to treat congenital and acquired fibrinogen deficiencies
26 November 2018 - Octapharma today announced that the Swiss Agency for Therapeutic Products, Swissmedic, granted marketing authorisation to its new ...
Posted by Michael Wonder on 22 Oct 2018
Novartis leukaemia drug approved in Switzerland
22 October 2018 - Basel-based pharmaceutical company Novartis has received approval for its personalised cell therapy Kymriah in Switzerland. Children ...
Posted by Michael Wonder on 02 Oct 2018
Swissmedic approves Ameluz in combination with daylight photodynamic therapy in Switzerland
1 October 2018 - Biofrontera announced today that Swissmedic, the Swiss national approval and supervisory authority for drugs and medical ...
Posted 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 ...