TOP STORIES OF 2016

ICH Announces New Guideline on Data Collection

At ICH's November 2016 meeting, the council announced new members and new guidelines.
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EMA Releases Data Integrity Guidance

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
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US Election Puts Health Policy in Play

What's ahead for the healthcare and pharmaceutical industries?
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Pfizer Comes Up Short in Lyrica Patent Battle

A UK appeals court ruled against Pfizer, saying generic-drug makers did not infringe on Lyrica's pain patent.
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EMA Releases Statement on Brexit

The agency says, for now, it's business as usual.
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Next Steps Uncertain for UK Pharma Industry Post Brexit Vote

In the wake of Britain's decision to exit the EU, pharma companies face uncertainty.
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European Pharmacopoeia Revises WFI Monograph

The agency now allows production of water for injection by non-distillation technologies.
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EUIPO Report Says Counterfeit Medicines Cost EU €10.2 Billion a Year

A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.
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EMA Suspends Drugs Due to Flawed Bioequivalence Studies

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
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US and Europe Collaborate on Patient Treatments

FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.
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