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Cinven to acquire clinical trial services and technology company

International private equity firm, Cinven, has agreed to acquire Bioclinica, a global provider of clinical trial services and technology to contract research organisations and pharmaceutical companies, from Water Street Healthcare Partners and JLL Partners.

R&D

Manufacturing

Packaging

Finance

Highlights

Legislation

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FDA issues draft guiances on next-gen sequencing-based tests

In support of the President Barack Obama’s Precision Medicine Initiative, the U.S. Food and Drug Administration has issued two draft guidances that, when finalised, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup.

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Sobi's Elocta approved in Switzerland for the treatment of haemophilia A

Swedish Orphan Biovitrum today announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved Elocta® (rFVIIIFc) for the treatment of haemophilia A.

Logistics

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Yorkshire pharma firm targets overseas medicine exports

A new medicines and pharmaceuticals wholesaler and distributor has been launched to solve difficulties faced by millions of people in Iraq in obtaining modern medicines to treat many illnesses effectively.

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Yorkshire medical diagnostic company inks global distribution deal

Yorkshire-based medical diagnostic company Abingdon Health as entered into a multi-year, global distribution agreement with electrophoresis specialist Sebia.

Marketing

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Gilead’s treatment for reducing HIV risk acquires EU marketing authorisation

The European Commission has granted marketing authorisation for Gilead Sciences’ once-daily Truvada in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk.

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Portola gains EMA marketing validation for factor Xa inhibitor antidote

Portola Pharmaceuticals has announced that the marketing authorisation application (MAA) for IndexXa, a Factor Xa inhibitor antidote, has been submitted to the EMA, completed the validation period, and has been accepted for review.