Blog
RSS FeedPosted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 04 Sep 2021
GSK’s shingles vaccine Shingrix gains UK license
2 September 2021 - GlaxoSmithKline's Shingrix has been licensed in the UK for the prevention of shingles in adults aged ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 20 May 2021
NICE turns down Janssen's Erleada
20 May 2021 - NICE has published draft guidance rejecting Janssen's Erleada (apalutamide) with androgen deprivation therapy for treating prostate ...
Posted by Michael Wonder on 19 Nov 2020
NICE recommends another medicine for patients with multiple myeloma
18 November 2020 - Recommended for listing in the Cancer Drugs Fund. ...
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 08 Jun 2020
NICE publishes appraisal consultation for isatuximab in combination with pomalidomide and dexamethasone for treating patients with relapsed and refractory multiple myeloma
4 June 2020 - The appraisal committee has considered the evidence submitted by the company and the views of non-company consultees ...
Posted by Michael Wonder on 04 May 2020
AstraZeneca to make Oxford vaccine as COVID-19 race heats up
30 April 2020 - AstraZeneca agreed to make an experimental coronavirus vaccine developed by Oxford University researchers as the race ...
Posted by Michael Wonder on 21 Apr 2020
Human trials to begin on COVID-19 vaccine by Thursday
21 April 2020 - A million doses of their experimental coronavirus vaccine could be ready as early as September, Oxford scientists ...
Posted by Michael Wonder on 16 Aug 2019
Brexit's disruptive impact on U.K. and European prescription drug market
15 August 2019 - The new Prime Minister of Britain, Boris Johnson, is one of the more strident Brexiteers. He's ...
Posted by Michael Wonder on 26 Mar 2019
EMA tells pharma companies to continue to prepare for UK’s withdrawal
25 March 2019 - With an extension in place that will push the UK's withdrawal from the EU back to ...
Posted by Michael Wonder on 22 Jan 2019
Sanofi UK marketing authorisation granted for Sanofi Pasteur’s trivalent influenza vaccine (split virion, inactivated) high dose (TIV high dose)
21 January 2019 - UK is the only European country where TIV high dose is approved. ...
Posted by Michael Wonder on 16 Jan 2019
EFPIA response to the UK parliament’s decision to reject the Brexit withdrawal agreement and political declaration
15 January 2019 - EFPIA notes the UK parliament’s decision to reject the Brexit withdrawal agreement and political declaration. ...
Posted by Michael Wonder on 12 Jan 2019
Time running out for ‘no-deal’ Brexit medicines laws
11 January 2019 - Needs parliament clearance before 29 March. ...
Posted by Michael Wonder on 05 Dec 2018
Europe’s drug regulator is backing away from the U.K.
4 December 2018 - Potential split sparks concern about delays, patient access. ...