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Generics

News

FDA approves MS and prostate generics posted 17/01/2020

The US Food and Drug Administration (FDA) in December 2019 approved the first generics of Gilenya (fingolimod) for multiple s...

EMA recommends approval for two new generics posted 12/12/2019

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November...

Dubai’s LIFEPharma signs historic agreement with Canada’s Apotex posted 22/11/2019

LIFEPharma, a wholly-owned subsidiary of the United Arab Emirates (UAE)-headquartered VPS Healthcare, has announced a histori...

Glenmark and Lupin gain FDA approval for nervous system agents posted 12/11/2019

Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for...

AB004665 Alimta and Orfadin generics approved by FDA posted 15/10/2019

The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cance...

 

Research

Medicare Part D has no impact on generics prescribing in long-term care posted 17/01/2020

A recent observational study [1] in long-term care facilities in the US shows that the Medicare Part D programme has no signi...

American College of Physicians makes new recommendations to cut drug spending posted 13/01/2020

A paper from the American College of Physicians (ACP) makes a number of policy recommendations to reduce costs of prescriptio...

The impact of generics regulation in Brazil posted 07/01/2020

Sales of originator drugs have decreased and the number of generics manufacturers have increased following the introduction o...

FDA generics approvals increasing but not for at-risk generics posted 07/01/2020

Analysis of generics approvals by the US Food and Drug Administration (FDA) reveals a slight increase in the total number of...

Safety of generics in US questioned posted 07/01/2020

US Food and Drug Administration (FDA) regulations guarantee a safe drug supply. However, author Michael White, from the Healt...

 

General

FDA sets up centre to improve quality of compounded drugs posted 24/01/2020

The US Food and Drug Administration (FDA) has established a Center of Excellence to improve the quality of compounded drugs,...

Ontario proposes regulatory changes to simplify drug formulary listing and cut government payments to pharmacies posted 03/01/2020

Following a number of changes in Canada’s generics and biosimilars landscape in 2019 [1-3], the Ontario Ministry of Health an...

WHO prequalifies antiparasitic API posted 06/12/2019

The World Health Organization (WHO) has announced the prequalification of Pyrimethamine, manufactured by Macleods Pharmaceuti...

FDA identifies causes of drug shortages, recommends solutions posted 22/11/2019

In response to growing concern over drug shortages, the US Food and Drug Administration (FDA) has released a report and accom...

16704526_l UK Labour Party proposes state run generics manufacturer posted 25/10/2019

In a speech at the 2019 Labour Party Conference, leader Jeremy Corbyn introduced the ‘Medicines For The Many’ initiative, whi...