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Inside Life Sciences
Issue 2

Brexit: Future of the EMA and EU/UK collaboration on medicines

A letter from Health Secretary Jeremy Hunt and Business Secretary Greg Clark published in the Financial Times on 4 July has put the future relationship between the EU and the UK life sciences sectors, and collaboration between regulators, at the forefront of Brexit discussions.

Avoiding the avoidable: deficiencies in clinical trial applications

There is not a single pharma or biotech company involved in product development that is not acutely aware of the huge levels of investment in financial and human resources that is required.

Excessive pricing of pharmaceuticals: the UK perspective

Following fines of £5.2 million and £84.2 million against Flynn Pharma and Pfizer respectively in December last year, the CMA has now published its decision in relation to excessive pricing of Epanutin (known generically as phenytoin), a branded medicine used in the treatment of epilepsy.

A Year in Patents: 14 September 2017

On 14 September, we are holding our annual Patents seminar.

Patient data under the spotlight

The latest medical data sharing controversy to attract the interests of regulators and the press, the arrangements between Royal Free London (RFL) and DeepMind, involved the transfer of approximately 1.6 million identifiable patient records, without explicit patient consent, for clinical testing of DeepMind's Streams application, relating to acute kidney injury.

Medical devices: A change for the better

Regulatory change within the world of medical devices is in full throttle with the adoption of the Medical Devices Regulation and the In Vitro Diagnostics Medical Devices Regulation, on 5 April 2017.

UPC: Latest news

Many will be forgiven for wondering when a firm date for the commencement of the new Unitary Patent and Unified Patent Court (UPC) regime will be announced.

Patents Court interprets SPC Regulation in relation to Markush claim

Following his SPC decisions earlier this year (noted in our recent edition of Inside Life Sciences), Arnold J has once again been called upon to interpret Article 3(a) of the SPC Regulation.