Blog
RSS FeedPosted by Michael Wonder on 21 Nov 2023
Sandoz launches Hyrimoz (adalimumab) high concentration formulation in Europe, aiming to improve patient care
21 November 2023 - Hyrimoz HCF to launch progressively across Europe. ...
Posted by Michael Wonder on 04 May 2023
Gene therapies are still hampered by substantial delays between approval and launch
3 May 2023 - Gene therapies hold promise for treating a wide range of diseases. Innovative companies such as bluebird bio ...
Posted by Michael Wonder on 07 Sep 2022
Rhythm Pharmaceuticals announces Imcivree (setmelanotide) granted marketing authorisation by European Commission for treatment of obesity and control of hunger in Bardet-Biedl syndrome
6 September 2022 - Setmelanotide now FDA approved and EC authorized for Bardet-Biedl syndrome. ...
Posted by Michael Wonder on 25 Aug 2022
First gene therapy for adults with severe haemophilia A, BioMarin's Roctavian (valoctocogene roxaparvovec), approved by European Commission
24 August 2022 - Maintains orphan drug designation in the EU providing 10 years of market exclusivity. ...
Posted by Michael Wonder on 11 Apr 2022
Drug makers pledge speedier European market launches to avert stricter regulation
11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...
Posted by Michael Wonder on 18 Feb 2022
Sandoz launches generic lenalidomide in 19 countries across Europe, expanding access to essential oncology medicine
18 February 2022 - Cost savings from Lenalidomide Sandoz can expand treatment options for patients with haemato-oncology conditions. ...
Posted by Michael Wonder on 30 Jan 2022
Medicines regulator pilot probes pharma delays in market launches
25 January 2022 - The European Medicines Agency wants to get a better understanding of drug companies’ commercial intentions and why. ...
Posted by Michael Wonder on 30 Mar 2021
Karyopharm receives conditional marketing authorisation from the European Commission for Nexpovio (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed and or refractory multiple myeloma
29 March 2021 - Second European Regulatory Filing Based on Phase 3 BOSTON Data Expected by April 2021. ...
Posted by Michael Wonder on 10 Nov 2020
Mirum Pharmaceuticals broadens Expanded Access Program for maralixibat in Alagille syndrome to Europe and Australia
5 November 2020 - Maralixibat Expanded Access Program now available for patients with pruritus associated with Alagille syndrome in Australia and ...
Posted by Michael Wonder on 05 Nov 2020
Sobi launch Doptelet (avatrombopag) in Europe
4 November 2020 - Sobi today announced the commercial launch of Doptelet (avatrombopag) in Europe, with the United Kingdom as ...
Posted by Michael Wonder on 27 Jul 2020
EU talks with Pfizer, Sanofi, J&J on COVID vaccines hit snags
28 July 2020 - European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson are mired in ...
Posted by Michael Wonder on 19 May 2020
Top pharma official rejects idea of free COVID-19 vaccine for all
18 May 2020 - A leading representative of the pharmaceutical industry has downplayed the idea of a vaccine against the ...
Posted by Michael Wonder on 19 May 2020
AveXis receives EC approval and activates “Day One” access program for Zolgensma, the only gene therapy for spinal muscular atrophy
19 May 2020 - Zolgensma (onasemnogene abeparvovec) is conditionally approved in Europe for the treatment of patients with spinal muscular atrophy ...
Posted by Michael Wonder on 13 Apr 2020
COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries
10 April 2020 - The company already increased its production capacity by 50% and is on track to further increase production ...
Posted by Michael Wonder on 09 Apr 2020
Global regulators stress need for robust evidence on COVID-19 treatments
9 April 2020 - International regulators have published a report today highlighting their considerations on the development of potential COVID-19 ...