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US$1.2 FDA contract for generic drug computational tool

The US Food and Drug Administration (FDA) Office of Generic Drugs (ODG) has awarded a US$1.2 million contract to support the development of a computational tool that will aid generic drug research.

Opportunities for generics with Korean patent expires in 2021

As part of ongoing action to improve the quality of generics and ensure an efficient and competitive generics market, the Korean Ministry of Food and Drug Safety (MFDS) announced that 158 patents for pharmaceutical products will expire in 2021.

AIFA updates the Transparency Lists for generics

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

New generics company to offer low-cost versions of high-cost generics

Billionaire Marc Cuban has launched a new generics company – Marc Cuban Cost Plus – which ‘is dedicated to producing low-cost versions of high-cost generic drugs’.

Generics applications under review by EMA – January 2021

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

A European pharmaceutical strategy promoting generics and biosimilars

The European Commission has adopted a new Pharmaceutical Strategy for Europe [1], as of 25 November 2020.

Pfizer sues Aurobindo and Dr Reddy’s over Ibrance (palbociclib) generics

US-based pharmaceutical company, Pfizer, has filed petitions in US courts against Aurobindo Pharma and Dr Reddy’s Laboratories.

China prioritizes drug innovation while increasing access to drugs approved abroad

China's pharmaceutical industry is undergoing a transformation towards high-quality and innovation-focused development, which has led to an explosion of new drug and clinical trial approvals in recent years.

Brazil sees a COVID vaccine setback but treatment advancement

In Brazil’s quest to tackle the COVID-19 pandemic, there has been a volunteer death in a potential vaccine trial, but a potential treatment option has emerged. Brazil has the second number of COVID-19 deaths, with over 159,033 deaths recorded up to end of October 2020. 

Reforms to health policy needed in Europe

The President of Medicines for Europe has made four key recommendations for European Union (EU) pharmaceutical policy,  while the Irish Pharmacy Union (IPU) says reforms to the health service could save Ireland millions of euros.