All EMA articles – Page 2
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BusinessBrexit raises regulatory worries
Risk of doubling legal burden for industry undermines referendum’s ‘red-tape cutting’ claims
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BusinessEU recommends withdrawing drugs approved on unreliable data
Indian firm Micro Therapeutic Research Labs accused of misrepresenting clinical data and documentation deficiencies
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BusinessBrexit could push Japanese pharma out of the UK
Warnings that Japanese R&D investment in the UK is endangered by plans to leave the EU
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BusinessViral cancer therapy approved in the US
T-Vec is the first approved oncolytic virus, but its limited treatment scope means it is unlikely to become a blockbuster
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BusinessIndian pharma under increased regulatory scrutiny
Import bans and tightened rules pose a significant challenge for companies
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Business
EU regulator calls for generic drug suspensions
The EMA wants hundreds of formulations off the market after identifying systematic fraud in a major Indian contract clinical research organisation
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Business
EU recommends Parkinson’s drug for approval
First new molecule for a decade, but Alzheimer’s still posing challenges as antibody treatment withdrawn from trials
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Business
EMA finalises trial transparency rules
Researcher access reinstated, but company redaction rights may cause issues
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BusinessEMA wrangles restrain trial data progress
Attempts to balance industry and research interests on transparency draw suggestions of improper collusion
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Business
US turnaround on Avandia restrictions
Researchers accuse regulator of face-saving U-turn over diabetes medication safety
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Business
First biosimilar antibody drugs approved in Europe
European commission gives final approval to generic infliximab copies
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Business
Biosimilar drugs step up complexity
First generic monoclonal antibodies recommended for approval in Europe
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BusinessClinical trial data release blocked by companies
Abbvie and Intermune sue the European Medicines Agency to stop it making data public
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Business
Laropiprant recalled
Merck & Co says it is recalling Tredaptive tablets, approved in the EU for treating patients with high cholesterol
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Business2012 pharma industry roundup
What were the bigger stories? And how did the industry fare overall?
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BusinessInterview: EMA head Guido Rasi
Guido Rasi, head of the European Medicines Agency, wants to see greater transparency in drug development
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Business
Roche rapped for side-effect reporting failure
European medicines regulator names and shames Swiss giant for not disclosing 80,000 instances of potential adverse drug reactions
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