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Allergan allows Amneal to market Alzheimer’s generic in 2025 posted 29/09/2016

Allergan has reached a deal with Amneal Pharmaceuticals (Amneal) over Allergan’s Alzheimer’s drug Namzaric. The agreement wil...

Patent wins and losses for Teva posted 16/09/2016

Teva Pharmaceutical Industries (Teva) – the world’s largest generics manufacturer – has reported a string of patent updates r...

Senators continue to raise concerns over price of Mylan’s EpiPen posted 06/09/2016

On 30 August 2016, a group of 20 US senators led by democrat Elizabeth Warren sent a letter to Mylan’s CEO Heather Bresch exp...

New generic versions of imatinib mesylate join the US market posted 06/09/2016

Two new generic versions of Novartis’ imatinib mesylate (marketed as Gleevec® and Glivec®) were launched in the US in early A...

Launches, approvals and court cases for Sun Pharma posted 06/09/2016

India’s largest drug manufacturer Sun Pharmaceutical Industries (Sun Pharma) has launched ready-to-administer anticancer drug...

 

Research

Different approaches to bioequivalence trials for EMA evaluation posted 23/09/2016

Selection of robust bioequivalence study designs is a difficult task for manufacturers of generics. Author Nathaniel Refalo f...

South Africa’s expedited registration policy not speeding up access to biosimilars posted 23/09/2016

Since South Africa’s National Department of Health (DoH) implemented a fast-track registration policy in 2003 the large numbe...

South Africa’s expedited registration policy for rapid access to critical medicines under threat by generics posted 23/09/2016

In 2003, the National Department of Health (DoH) of South Africa implemented a fast-track registration policy, not only for n...

Driving down drug prices: how regulators can influence affordability posted 23/09/2016

In recent years there has been increasing global concern over drug prices and their affordability. And what is the role playe...

Generics in seizure control posted 23/09/2016

Are generic medicines for the control of epileptic seizures bioequivalent to their brand-name counterparts? Steven Karceski [...

 

General

Why do generic drug prices keep on rising? posted 29/09/2016

Consumers are paying more and more for their drugs, and especially in the US. The US allows manufacturers to set their own pr...

Generics applications under review by EMA – August 2016 posted 23/09/2016

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

Indian generics manufacturer Lupin buys 21 brands from Japan’s Shionogi posted 02/09/2016

India’s third biggest drug producer Lupin Ltd (Lupin) has announced that it will purchase 21 generic medicine brands from Jap...

EMA halts sales of unreliable generics posted 21/08/2016

The European Medicines Agency (EMA) has recommended that the sales of several generics, including those produced by Teva and...

Extortionate increases in prices of 32 drugs a result of loophole in NHS pricing structure posted 08/08/2016

An investigation by The Times has exposed a small group of UK-based entrepreneurs to have profited vast amounts of money from...

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