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FDA lifts import ban on Chinese API to prevent shortages

The US Food and Drug Administration (FDA) has lifted its ban on one of the active pharmaceutical ingredients (APIs) from China-based Zhejiang Hisun Pharmaceutical (Hisun) due to a ‘critical drug shortage concern’.

Hilary Clinton goes after Valeant for ‘predatory pricing’

Presidential candidate Hilary Clinton has said in a new advertisement that she is ‘going after’ drugmaker Valeant Pharmaceuticals (Valeant) for its ‘predatory pricing’.

Medicines Patent Pool signs first sub-licences for HCV med daclatasvir

The Medicines Patent Pool (MPP) announced on 20 January 2016 the signing of its first sub-licences for generics of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

European generics and biosimilars makers adopt disclosure rules

The European Generic and Biosimilar Medicines Association (EGA) has published disclosure rules for the generic, biosimilar and value added medicines industry. This builds on the EGA Code of Conduct adopted in 2015. 

Generics applications under review by EMA – December 2015

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].

Proposed rebates will hit patients, not drug companies

Attempts by US Congress to halt the rise in generics prices with new rebates payable by drugmakers has received a stinging rebuff from the Generic Pharmaceutical Association (GPhA).

US politicians form Affordable Drug Pricing Task Force

On 4 November 2015, democratic members of the House Committee on Oversight & Government Reform launched the Affordable Drug Pricing Task Force, which its members say will bring about ‘meaningful action to combat the skyrocketing costs of pharmaceuticals’.

FDA making progress with ANDA backlog

Despite an increase in the volume of abbreviated new drug application (ANDA) submissions, Type II API Drug Master Files (DMFs), supplements and amendments during financial year (FY)2014, the US Food and Drug Administration (FDA) has acted on more pending submissions compared to FY2013.

Brand-name drugmakers gain extra days of patent protection

Brand-name drugmakers have gained some extra time, be it only days, for protection of their originator drugs after a ruling by the Court of Justice of the European Union clarified the date that drug patents expire.

Sun Pharma recalls drugs from troubled Halol plant

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again having to recall drugs from its troubled Halol plant in Gujarat, India.