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News

EMA recommends approval of abiraterone and thiotepa generics posted 02/04/2021

In January and February 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) hel...

Teva and Sandoz launch new generics posted 26/03/2021

In early 2021, Teva Pharmaceuticals announced the US launch of generic versions of NuvaRing® and AZOPT®. During the same peri...

16704526_l EMA recommends approval of fourth COVID-19 vaccine posted 19/03/2021

11 March 2021 saw the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the four...

Posaconazole, silodosin and droxidopa generics from Lupin and Sandoz posted 12/03/2021

Early 2021 saw the launch of two generic versions of posaconazole in Canada and the US. In Canada, the first generic version...

Biocon and Lupin launch generic tacrolimus capsules in US posted 05/02/2021

India-based generics makers Biocon and Lupin have both launched generic tacrolimus capsules in the US.

 

Research

Dispensing branded drugs costs Medicare over a billion dollars posted 09/04/2021

Branded drugs dispensed instead of generics at the request of physicians and patients have incurred annual costs of over US$1...

Technological approaches to drug repurposing for cancer treatment posted 08/04/2021

Cancer is one of the leading causes of death in the world today, causing nearly 10 million deaths in 2018 alone. Despite exte...

Debate about generic versus brand-name drugs for glaucoma posted 24/03/2021

Glaucoma is a chronic, largely asymptomatic disease that often needs lifelong treatment. The choice of drugs is extremely imp...

The role of authorized generics in improving access to medicines posted 12/03/2021

In recent years, many authorized generic drug products have been launched by pharmaceutical companies at lower prices than th...

Approving generics of polymer-based parenteral long-acting drugs posted 12/03/2021

To assure the safety and the efficacy of drugs, quality and batch-to-batch reproducibility need to be guaranteed. In the case...

 

General

US$1.2 FDA contract for generic drug computational tool posted 16/04/2021

The US Food and Drug Administration (FDA) Office of Generic Drugs (ODG) has awarded a US$1.2 million contract to support the...

Opportunities for generics with Korean patent expires in 2021 posted 12/03/2021

As part of ongoing action to improve the quality of generics and ensure an efficient and competitive generics market, the Kor...

AIFA updates the Transparency Lists for generics posted 26/02/2021

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 15 January 2021 the update of its Transparency...

New generics company to offer low-cost versions of high-cost generics posted 29/01/2021

Billionaire Marc Cuban has launched a new generics company – Marc Cuban Cost Plus – which ‘is dedicated to producing low-cost...

Generics applications under review by EMA – January 2021 posted 22/01/2021

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