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Hospitals to start own generics company posted 26/01/2018

In an effort to combat regular shortages and the increasing prices of drugs, four of the US’s largest hospital systems have m...

Mylan appeals to FDA: no approval for generic Advair Diskus based on multi-batch PK BE studies posted 19/01/2018

On 5 December 2017, Mylan filed a citizen petition asking the US Food and Drug Administration (FDA) not to approve any abbrev...

Mylan/Aspen launch generic busulfan injection posted 08/12/2017

US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), ann...

Drugmakers waking up to potential value of branded generics posted 01/12/2017

Pharma companies are making a move into what may become a lucrative sector – branded generics. The concept is simple – take a...

FDA tentatively approves pemetrexed generic posted 24/11/2017

Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and D...

 

Research

Persistence with generic imatinib in CML patients posted 23/02/2018

A study carried out by researchers from Canada investigated the clinically comparability of brand-name and generic imatinib i...

Efficacy and safety of generic imatinib after switching posted 23/02/2018

A study carried out by researchers from the US investigated switching from originator to generic imatinib in patients treated...

Approval rating and opinion on generic drugs in Italy: a cross-sectional study in the Liguria region posted 09/02/2018

Italy has the lowest generics market share by volume in Europe (less than 20%), coming just below Portugal and Spain. While i...

Interchangeability of gabapentin generics posted 02/02/2018

Researchers from The Netherlands and the US developed a model that could describe pharmacokinetic data for generic gabapentin...

Treatment of chronic myeloid leukaemia patients with generic imatinib in Algeria posted 19/01/2018

In a developing country like Algeria expensive therapies are not available. Alternative approaches are needed. In Algeria Ima...

 

General

Canada’s generics industry to cut prices by up to 40% posted 23/02/2018

The pan-Canadian Pharmaceutical Alliance (pCPA) announced on 29 January 2018 that together with participating federal, p...

Europe calls for more drugs repurposing posted 15/02/2018

The European Commission (EC) published a paper for the 8th Meeting of the STAMP Expert Group on 8 December 2017 regarding cas...

FDA denies Novo Nordisk petition to block generic liraglutide posted 02/02/2018

On 5 January 2018, the US Food and Drug Administration (FDA) denied Novo Nordisk’s October 2017 citizen petition [1] that sou...

France fines J&J 25 million Euro for blocking generics posted 19/01/2018

A fine of Euros 25 million was imposed on Janssen-Cilag and its parent company Johnson & Johnson (J&J) by the French...

Generics applications under review by EMA – January 2018 posted 19/01/2018

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the lo...

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