Latest News in the pharma Industry

Policy & Regulation

Pharma Firms Seek EU Concessions to Protect Drug Supply to Troubled Nations

Pharma Firms Seek EU Concessions to Protect Drug Supply to Troubled Nations

29 Jun 2012

The head of the EFPIA has urged EU leaders to grant concessions to prevent problems with the supply and demand of medicines in the region.

Read more 
EMA Finalises Guidance on Medicines Containing Monoclonal Antibodies

EMA Finalises Guidance on Medicines Containing Monoclonal Antibodies

19 Jun 2012

The EMA has finalised two documents providing pharmaceutical companies with guidance on how to develop medicines containing monoclonal antibodies.

Read more 
China Revises Patent Law in Fight for Cheaper Drugs

China Revises Patent Law in Fight for Cheaper Drugs

14 Jun 2012

The amended law allows the country to issue compulsory licences to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

Read more 
Mylan Settles Provigil Litigation with Teva

Mylan Settles Provigil Litigation with Teva

11 Jun 2012

Mylan is permitted to launch its Modafinil Tablets, 100 mg and 200 mg, on August 10, 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva.

Read more 
US Legislation Will Ensure Tighter Checks on Foreign Drug Factories

US Legislation Will Ensure Tighter Checks on Foreign Drug Factories

28 May 2012

US lawmakers are taking steps to increase the safety of drugs manufactured on foreign soil.

Read more 
FDA Approves Generic Versions of Blood Thinner Plavix

FDA Approves Generic Versions of Blood Thinner Plavix

22 May 2012

Clopidogrel is FDA-approved to treat patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery.

Read more 
US ahead of Canada & Europe in Drug Approvals

US ahead of Canada & Europe in Drug Approvals

22 May 2012

A study has found that US FDA generally approves drugs faster and earlier than its counterparts in Canada and Europe.

Read more 
FDA Issues Warning over CCSVI Treatment

FDA Issues Warning over CCSVI Treatment

15 May 2012

The FDA is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices.

Read more 
US Appeals Court Upholds Abilify Patent

US Appeals Court Upholds Abilify Patent

14 May 2012

Otsuka Pharmaceutical's antipsychotic drug Abilify is protected until April 2015, preventing generic versions of the drug from being launched until that time, a US court has ruled.

Read more 
FDA Committee Votes in Favour of Quad Approval

FDA Committee Votes in Favour of Quad Approval

14 May 2012

Gilead Sciences has announced that a US FDA committee has voted to support the approval of the Quad regimen and Truvada.

Read more 
FDA & EMA Approve Genzyme  Filling & Finishing Suite

FDA & EMA Approve Genzyme Filling & Finishing Suite

7 May 2012

With this approval, Genzyme has nearly doubled its ability to fill and finish Myozyme and Lumizyme produced at the 4000 liter bioreactor scale.

Read more 
EMA Recommends Authorisation of Forxiga for Type 2 Diabetes

EMA Recommends Authorisation of Forxiga for Type 2 Diabetes

25 Apr 2012

The Agency’s Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Forxiga, a novel treatment for type 2 diabetes mellitus.

Read more