Blog
RSS FeedPosted by Michael Wonder on 13 Nov 2019
FDA’s Project Orbis may expand to Singapore and Switzerland
12 November 2019 - The US FDA may expand a pilot project that allows for simultaneous drug approval decisions from ...
Posted by Michael Wonder on 10 Oct 2019
Swissmedic reviewing licence extension for the SGLT2 inhibitor Invokana (canagliflozin) in fast-track procedure
9 October 2019 - The CREDENCE renal outcomes study, which was stopped early in July 2018 owing to positive efficacy findings, ...
Posted 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 21 Feb 2019
High pharma margins squeeze health care systems
19 February 2019 - The WHO found that for every dollar invested in cancer research, pharmaceutical companies earned on average $14.50 ...
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 02 Nov 2018
Federal office decides drug price cuts
2 November 2018 - There will be an average drop of almost 20% in the price of 288 medicines from ...
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 05 Jul 2018
International work-sharing pilot - apalutamide (Erlyand)
5 July 2018 - Apalutamide (Erlyand) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...
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 17 Apr 2018
ACSS - NCE work-sharing pilot
17 April 2018 - The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration, ...
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 ...