EU

EMA Transparency Policy upheld by General Court: companies unable to show that submissions to EMA are confidential

Eveline Van Keymeulen

On 6 February 2018, the General Court delivered three very carefully considered judgments in cases brought by companies who objected to the disclosure in their entirety of documents submitted to the European Medicines Agency (EMA) for the purposes of gaining a marketing authorisation or additional market exclusivity (see our previous update (see our previous blog Read More

CJEU’s first ruling on the classification of software as a medical device: A predictable scenario with a possible cliff-hanger?

Eveline Van Keymeulen

In its judgment dated 7 December 2017 (Case C-329/16) the Court of Justice of the EU – rather unsurprisingly – confirmed that software which uses patient-specific data to aid prescription by detecting contra-indications, interactions with medicinal products and excessive doses falls within the definition of a medical device for the purposes of the Medical Devices Directive. Read More

Life Sciences IPOs – 5 things to consider

Michael Bloch

After spending all day last Wednesday at Biotech & Money’s IPO workshop presenting and talking to Life Sciences start ups about their IPO plans, we thought it might be interesting to bring together some of our key thoughts on IPO preparedness. Companies thinking about an IPO can never start planning too early.  IPO planning and Read More

EU General Court rules on transparency of clinical trial data

Marco de Morpurgo

Today, the General Court delivered three landmark judgments relating to transparency of clinical trial data in the EU.  The long-awaited rulings clarify the scope of commercial confidentiality with regard to data pertaining to centrally approved medicinal products and included in the MA application dossier.  The three rulings uphold the European Medicines Agency (EMA)’s decisions to Read More

EMA survey of UK based pharmaceutical companies on Brexit plans

Jacqueline Bore

Yesterday, the European Medicines Agency (EMA) announced its plan to consult all marketing authorisation holders of centrally authorised products that are located in the UK or who have an important part of their site operations in the UK on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of Read More