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Executive Editor
Ireland
13+ years of experience
Generics Bulletin
By David Wallace 25 Oct 2022
Chirag Patel and Chintu Patel have returned to being co-CEOs of Amneal, just over a year after the firm completed its merger with Impax. Rob Stewart – who was president and CEO of Amneal – and executive chairman Paul Bisaro have resigned from the roles.
Topic Company Analysis
Generics Bulletin
By David Wallace 18 Jan 2022
WaveData’s compilation of the fastest-rising UK generics prices in December showed several products across multiple presentations more than doubling their average trade prices to independent pharmacists.
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 14 Sep 2021
The Medicines Patent Pool has announced that the first shipments of dolutegravir under a fresh agreement covering upper-middle-income countries have reached Azerbaijan and Belarus.
Generics Bulletin
By David Wallace 08 Jun 2021
Celltrion has pushed into another new market with its Remsima SC subcutaneous version of infliximab, launching the innovative biosimilar in Canada.
Generics Bulletin
By David Wallace 22 Apr 2021
Attendees to Medicines for Europe’s virtual summit on biosimilars heard how learning from experiences across Europe can allow individual countries to build a toolbox of policies to help create a sustainable biosimilars market.
Generics Bulletin
By David Wallace 06 Apr 2021
Guidance published by the US FDA in the form of a question-and-answer document addresses questions from ANDA applicants about generic drug development during the COVID-19 pandemic.
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
In the first part of an exclusive two-part interview, James Burt – Accord’s executive vice-president for Europe, the Middle East and North Africa – talks to Generics Bulletin about the key actions taken by the generics industry to mitigate the coronavirus pandemic, and the changed landscape that the off-patent arena can expect to see in future.
Topic Coronavirus Manufacturing
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
25 Jul 2022
Generics Bulletin
25 Jul 2022
Generics Bulletin
22 Jul 2022
Generics Bulletin
22 Jul 2022
Generics Bulletin
20 Jul 2022
Generics Bulletin
20 Jul 2022
Generics Bulletin
18 Jul 2022
Generics Bulletin
18 Jul 2022
Generics Bulletin
15 Jul 2022
Generics Bulletin
15 Jul 2022
Pink Sheet
15 Jul 2022
Pink Sheet
15 Jul 2022
Generics Bulletin
15 Jul 2022
Generics Bulletin
15 Jul 2022
Generics Bulletin
15 Jul 2022
