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Executive Editor
Ireland
12+ years of experience
Generics Bulletin
By David Wallace 01 Dec 2021
Bio-Thera Solutions had been hoping to become the first Chinese biosimilars developer to win an FDA approval, for its BAT1706 bevacizumab candidate. However, the announced FDA action date for the application has come and gone with no word from the company or regulator.
Generics Bulletin
By David Wallace 17 Sep 2021
The EU’s creation of a Health Emergency Response Authority to deal with future health threats has been welcomed by off-patent industry association Medicines for Europe. However, the organization pointed out current policy and regulatory weaknesses that must be addressed if HERA is to be successful.
Generics Bulletin
By David Wallace 18 Jan 2021
Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.
Generics Bulletin
By David Wallace 08 Dec 2020
Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged
Topic Coronavirus EU Policy & Regulation
Generics Bulletin
By David Wallace 29 Nov 2020
Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.
Topic Coronavirus EU Policy & Regulation
Generics Bulletin
By David Wallace 27 Nov 2020
Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.
Topic Biosimilars Launches Regulation
Generics Bulletin
By David Wallace 27 Nov 2020
Alberta has become the second Canadian province to announce a biosimilar switching program, following the example set by British Columbia earlier this year. The move has been welcomed by Biosimilars Canada but criticized by originator-backed body Crohn’s and Colitis Canada.
Topic Biosimilars Regulation
Generics Bulletin
By David Wallace 11 Sep 2020
World Health Organization recommendations to use dexamethasone and hydrocortisone to treat patients with severe and critical COVID-19 demonstrate the potential for common and low-cost generics in fighting the coronavirus pandemic.
Topic Coronavirus
Generics Bulletin
By David Wallace 09 Sep 2020
Guidance from the UK’s MHRA on post-Brexit arrangements relevant to the off-patent industry has been welcomed by local industry body the BGMA. However, it has warned that time is short to prepare for the end of the UK-EU transition period, with new guidance in certain areas “critical.”
Topic Brexit
Generics Bulletin
By David Wallace 15 Jun 2020
Dr Reddy’s has become the latest firm to strike a licensing deal with Gilead for its remdesivir potential treatment for COVID-19.
Topic Coronavirus
Generics Bulletin
By David Wallace 06 Apr 2020
Australia’s competition regulator, the ACCC, has granted a conditional dispensation to allow generics industry association the GBMA and brand body Medicines Australia to work together to help address the coronavirus pandemic by sharing information on stock, inventory, manufacturing and the supply chain. However, tender pricing will not be among the subjects discussed.
Topic Coronavirus
Generics Bulletin
By David Wallace 19 Mar 2020
Industry has welcomed the European Commission’s introduction of priority freight lanes, or ‘green lanes’, for essential goods to help address the challenges posed by the coronavirus outbreak.
Topic Coronavirus
Generics Bulletin
By David Wallace 08 Nov 2019
Teva and Celltrion have launched the first biosimilar rituximab in the US, introducing Truxima at a 10% discount to Roche’s Rituxan.
Topic Biosimilars Strategy
Generics Bulletin
By David Wallace 30 Jul 2019
As Sandoz reported its second-quarter financial results, the firm revealed details of a previously unannounced development program for biosimilar denosumab.
Topic Company Analysis Biosimilars
Generics Bulletin
By David Wallace 07 Mar 2019
Two new categories – Value Added Medicine Of The Year and Legal Strategy Of The Year – have been added to the Global Generics & Biosimilars Awards in 2019, which will take place on 5 November in Frankfurt, Germany.
Topic BioPharmaceutical Biosimilars
Generics Bulletin
25 Jul 2022
Pink Sheet
15 Jul 2022
Generics Bulletin
15 Jul 2022
Generics Bulletin
15 Jul 2022
Generics Bulletin
15 Jul 2022
Generics Bulletin
15 Jul 2022
Generics Bulletin
14 Jul 2022
Generics Bulletin
13 Jul 2022
Generics Bulletin
12 Jul 2022
Generics Bulletin
06 Jul 2022
Generics Bulletin
04 Jul 2022
Generics Bulletin
30 Jun 2022
Generics Bulletin
27 Jun 2022
Generics Bulletin
24 Jun 2022
Generics Bulletin
22 Jun 2022
