Medicines repurposing project launched in Europe

Generics/General | Posted 21/01/2022

In late October 2021, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) announced the launch of a pilot project to support the repurposing of medicines.

Pfizer to produce generic COVID-19 pill in eight countries of Latin America

Generics/News | Posted 14/01/2022

US-based pharmaceutical company Pfizer announced a licensing agreement to allow other manufacturers to produce generic versions of its COVID-19 pill Paxlovid (PF-07321332*) in order to generate more affordable access to developing countries.

MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments

Generics/General | Posted 10/12/2021

In October and November 2021, Merck and Pfizer signed licensing agreements with the United Nation’s backed Medicines Patent Pool (MPP) to help increase access to their investigational COVID-19 oral antiviral treatment options. Respectively, these are molnupiravir and Paxlovid. Creating these royalty free licences will allow for generic versions of the drugs to be produced and distributed in approximately 100 low- and middle-income countries worldwide.

First eslicarbazepine epilepsy generic to be approved in China

Generics/News | Posted 10/12/2021

In China, the Yangtze River Pharmaceutical Group submitted the first marketing application of a class 3 generic drug, eslicarbazepine acetate, for use to treat patients with epilepsy, on 15 October 2021.

FDA closes Zhejiang Huahai Pharmaceutical warning letter

Generics/General | Posted 19/11/2021

The US Food and Drug Administration (FDA) has stated that it has closed the warning letter issued to Chinese manufacturer Zhejiang Huahai Pharmaceutical in 2018.

Pfizer and Merck COVID-19 antiviral progress

Generics/News | Posted 12/11/2021

Pfizer has announced that its COVID-19 oral antiviral candidate, Paxlovid, can significantly reduce hospitalization and death of COVID patients. At the same time, Merck is under pressure to get its COVID-19 antiviral, molnupiravir, to reach those in developing countries.

FDA reaches 100 generics approvals

Generics/General | Posted 12/11/2021

As of September 2021, the US Food and Drug Administration (FDA) has reached an important milestone of approving more than 100 generic drug applications with a competitive generic therapy (CGT) designation.

Call for drug pricing transparency

Generics/Research | Posted 05/11/2021

By 2023, pharmaceutical expenditure is expected to reach US$1.5 trillion [1]. This causes significant strain on healthcare systems worldwide and work is underway to bring pharmaceuticals’ spending down.

Sun Pharma and Dr Reddy’s generics progress in EU and US

Generics/News | Posted 05/11/2021

October 2021 saw the steps forward in the approval of a Sun Pharmaceutical’s sitagliptin fumarate generic in Europe, and Dr Reddy’s lenalidomide generic in the US.

High price of cancer medicines make treatment unaffordable globally

Generics/Research | Posted 29/10/2021

Cancer is the leading cause of death worldwide. Currently, there are increasing concerns about the price of cancer medicines and how this can limit patient access to lifesaving treatments. Now, a new study published in Applied Health Economics and Health Policy [1] calls for strengthened pricing policies that can ensure affordable cancer treatment for all.