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Deputy Editor
Ireland
+11 year(s) experience
Generics Bulletin
Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.
Generics Bulletin
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
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
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
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
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
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
In the wake of the revelation that the US has secured rights to almost all of Gilead’s remdesivir supplies through September 2020, compulsory licensing had been raised as a possible way for countries to procure versions of the COVID-19 treatment. However, Medicines for Europe has cautioned that the procedure will not be practical to apply in Europe.
Generics Bulletin
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
As Hikma launches propofol vials in three presentations in the US to address a local shortage, CEO Siggi Olafsson explains how the company is more broadly keeping on top of the higher demand generated by the coronavirus pandemic.
Topic Coronavirus
Generics Bulletin
In an exclusive interview with Generics Bulletin, Celltrion Healthcare’s UK commercial director, Matt Eddleston, has set out the firm’s plans to roll out an antibody test and trial two antiviral treatments for COVID-19. Meanwhile, the company’s recently-launched subcutaneous version of biosimilar infliximab, Remsima SC, is helping to free up hospital space in the UK by allowing treatment to be moved out of that setting as the coronavirus pandemic progresses.
Topic Coronavirus
Generics Bulletin
Australia’s off-patent industry association, the GBMA, and local brand organization Medicines Australia have set out their plans for collaborating on supplying essential medicines amid the coronavirus pandemic.
Pink Sheet
A temporary framework has been adopted by the European Commission that will allow companies and associations to co-ordinate efforts to tackle the coronavirus pandemic without raising competition concerns. The move has been welcomed by the European off-patent industry.
Topic Coronavirus
Generics Bulletin
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
Leaders around the world must do all they can to ensure that medicines manufacturing and the supply chain are operating at full capacity as part of efforts to tackle the coronavirus outbreak, global off-patent industry association the IGBA has urged.
Topic Coronavirus
Generics Bulletin
09 Apr 2021
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08 Apr 2021
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08 Apr 2021
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07 Apr 2021
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06 Apr 2021
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06 Apr 2021
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06 Apr 2021
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06 Apr 2021
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01 Apr 2021
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01 Apr 2021
Generics Bulletin
31 Mar 2021
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31 Mar 2021
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31 Mar 2021
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29 Mar 2021
Generics Bulletin
29 Mar 2021
