US charity calls for release of diabetes drug data

American Diabetes Association demands review of incretin-based medicines linked to pancreatic cancer

Teva and Sun pay dearly for 'at-risk' generic Protonix launch

Will pay $2.15bn in landmark patent infringement lawsuit

EMA seeks comment on final biosimilar guidance

Outlines thinking on non-clinical and clinical development requirements

France investigates Teva after packaging mix-up

Some packages of diuretic furosemide found to contain sleeping pill zopiclone

Data on diabetes drug links to cancer withheld says investigation

BMJ and Channel 4 say access to raw trial data would help resolve uncertainly about GLP-1 agonists

Ben Goldacre: No escape from trial transparency

Bad Pharma author says AllTrials and new European legislation make data disclosure unavoidable

FDA panel says Avandia restrictions should be eased

Vote backs wider use of GSK's drug in diabetes

FDA to review restrictions on GSK's diabetes drug Avandia

Advisory committee to discuss re-analysis of diabetes drug’s safety data

Nine pharma firms face EU fines over pay-for-delay deals

Lundbeck could be the hardest hit with a maximum penalty of €240m

The future of HTA harmonisation in Europe

The variety and variability of European health technology assessment criteria have created a challenging environment for pharma and a need for much greater harmonisation

India's patents versus India's patients

What the Roche Pegasys case means for big pharma
UK Bribery Act: A game changer

The Director of the Serious Fraud Office intends to enforce the Act ‘vigorously’ – it would be wise to take him at his word

More regulatory features

EMA backs Pomalidomide Celgene in multiple myeloma

Further positive CHMP opinions for new medicines form Aegerion, Teva and more
GSK/ Valeant's Trobalt set for EU restrictions

Eye concerns prompt CHMP to recommend last-line use for the epilepsy drug
EU Parliament panel backs updated clinical trials regulations

But pharma industry concerned about measures to increase transparency
France ignores EMA and suspends Bayer's Diane 35

National Agency for the Safety of Drugs and Health Products contradicts PRAC verdict
India puts cost controls on medicines

Drugs (Prices Control) Order 2013 reduces price of hundreds of drugs
EMA says Bayer's Diane 35 should remain on European market

Agency investigation concludes acne treatment's benefits outweigh its risks
Novo Nordisk: Strict US regulation threatens innovation

Warning from CEO Sorensen comes after Tresiba and Ryzodeg fail to win FDA approval

More regulatory news

Latest regulatory appointments

Astellas appoints Dr Songlin Xue head of global pharmacovigilance

He joins from Takeda and was formerly at Novartis and Wyeth
Agneta Brandt joins EMA as head of infrastructure

Joins as company prepares to move offices
GSK's Ellen Strahlman joins med tech firm BD

Will serve as the US company's chief medical officer
EMA’s Pharmacovigilance Risk Assessment Committee gains new members

Filip Babylon to represent HCP organisations and Albert van der Zeijden to represent patient organisations
Genzyme’s Richard Moscicki joins FDA

Provides regulatory agency with more than 20 years of industry experience

More appointments

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