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Analysis and opinion covers key topic areas such as:
Generics Bulletin
By Chloe Kent 18 Jan 2022
Medicines for Ireland has appointed Accord Healthcare Ireland managing director Padraic O’Brien as chairperson and Teva Ireland director of generic products Paul Neill as vice chairperson of the Irish industry association. The changes come just a few weeks after Ireland implemented its new framework agreement on off-patent pricing.
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 Akriti Seth 14 Sep 2021
India’s Alkem has delivered a strong quarter with a boost in its domestic business on the back of “strong volume-led growth in the acute therapies and faster than market growth in chronic therapies.” However, the company saw a slight YoY decline in the US.
Generics Bulletin
By Akriti Seth 22 Jun 2021
After a production setback, Aspen and Johnson & Johnson announce a donation of 300,000 vaccines to South African teachers. Strides partners with Ennaid for an oral COVID drug, while Dr Reddy’s, Lupin, Cipla and Sun Pharma Partner with Eli Lilly for baricitinib in India and Formycon receives approval for early action for its COVID-19 drug.
Generics Bulletin
By Akriti Seth 16 Jun 2021
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
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 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 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
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 Aidan Fry 27 Nov 2020
California’s 2020-2021 fiscal budget includes plans to work with manufacturers to establish the state’s own generics label. But industry is sceptical that the initiative will deliver the savings that the US state hopes for.
Generics Bulletin
By Akriti Seth 17 Nov 2020
Pfizer has reported 80% growth in its global biosimilars business for the third quarter of 2020, on the back of recent oncology launches. Though the company’s sterile injectables saw a slight drop in business, Pfizer’s biopharma business saw 4% growth.
Topic Coronavirus Biosimilars Deals
Generics Bulletin
By Akriti Seth 25 Sep 2020
The AAM has published a timely guide highlighting various voter issues of concern in the run-up to the US elections, including anti-competitive tactics building on monopoly pricing and weak patent laws. The AAM has also called for policies to encourage generic and biosimilar entry in the market while the guide also focuses on policies around the US supply chain.
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
01 Feb 2023
Generics Bulletin
01 Feb 2023
Generics Bulletin
31 Jan 2023
Generics Bulletin
31 Jan 2023
Generics Bulletin
30 Jan 2023
Generics Bulletin
30 Jan 2023
Generics Bulletin
27 Jan 2023
Generics Bulletin
27 Jan 2023
Generics Bulletin
27 Jan 2023
Generics Bulletin
27 Jan 2023
Generics Bulletin
26 Jan 2023
Generics Bulletin
26 Jan 2023
Generics Bulletin
26 Jan 2023
Generics Bulletin
25 Jan 2023
Generics Bulletin
25 Jan 2023
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