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News

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...

EMA approval for tacrolimus generic posted 10/11/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that...

 

Research

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...

The Greek problem of generics pricing posted 18/01/2018

Over the past few decades spending on prescription pharmaceuticals has increased faster than total health spending and gross...

Jan Aushadhi and affordability and accessibility of medicines in India posted 05/01/2018

The pharmaceutical industry in India ranks third in the world in terms of volume and 14th in terms of value. According to the...

Generic metformin bioequivalent in healthy volunteers in Nigeria posted 08/12/2017

Researchers from Nigeria’s Obafemi Awolowo University have found generic metformin sourced in the country to be ‘not inferior...

Perceptions and attitudes towards generics in South Korea posted 24/11/2017

A survey of the perception and attitude of South Korean physicians towards generics has shown that not much has changed despi...

 

General

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...

REMS issues come under FDA spotlight posted 11/12/2017

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has once again chastised brand-name drug companies that...

Kenya needs to increase use of generics to combat rising costs posted 11/12/2017

Kenyan medical insurance management firms are advising that they will only pay for generics and not brand-name prescriptions.

Texan judge invalidates Restasis patents posted 11/12/2017

On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine...