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Life sciences weekly email
Most recent legal updates
EMA Committee for Advanced Therapies meeting highlights for January 2017 (EU)
The EMA Committee for Advanced Therapies finalised scientific recommendations on various products to be classified as advanced therapy medicinal products at its meeting on 18-20 January 2017.
Drugs strategy: European Commission proposes new EU Action Plan on Drugs (2017-20)
On 15 March 2017, the European Commission proposed a new EU Action Plan on Drugs (2017-20). It follows the first EU Action Plan on Drugs (2013-16) and sets out the actions that will be implemented to achieve the objectives of the EU Drugs Strategy fo ...
CAT establishes confidentiality ring in Flynn and Pfizer CMA appeals
On 15 March 2017, CAT published orders establishing confidentiality rings in the appeals by Flynn and Pfizer, under section 46 of the Competition Act 1998 against the CMA decision imposing fines for abuse of dominant position through excessive pricin ...
Non-Compliance and enforcement activity for the week ending 15 March 2017 (multi-jurisdictional)
Compliance and enforcement activity for the week ending 15 March 2017:
Market activity for the week ending 15 March 2017 (multi-jurisdictional)
Biotech and pharmaceutical market activity announced in the week ending 15 March 2017.
EMA publishes updated guidance on applications for centralised type IA and IB variations (EU)
EMA updates its guidance on completing the application form for type IA and IB variations to marketing authorisations under the centralised procedure.
FDA Approves Kisqali as Part of a Combination Treatment for Advanced Breast Cancer (US)
The FDA approved Novartis Pharmaceuticals Corp.'s Kisqali® (ribociclib, formerly known as LEE011), in combination with an aromatase inhibitor, to treat postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 nega ...
FDA Warns of Potential Contamination of Static Preservation Solution (US)
The FDA issued a drug safety communication on the potential contamination of SPS-1 Static Preservation Solution (SPS-1), an organ preservation solution.
FDA Identifies Certain Class II Medical Devices That Will Be Exempt from Premarket Notification Requirements (US)
The FDA identified types of class II medical devices that, subject to certain limitations, will be exempt from premarket notification requirements.
House of Commons Foreign Affairs Committee publishes report on implications of "no deal" by Brexit
On 12 March 2017, the House of Commons Foreign Affairs Committee published a report on the potential implications for the UK if the government does not reach agreement with the EU by the end of the two-year negotiating period set by Article 50 of the ...
A multi-jurisdictional table summarising recent bio and pharma acquisitions, collaborations and other transactional activity
A multi-jurisdictional table summarising significant regulatory fines, investigations, non-compliances and enforcements relating to R&D and commercialisation of medicines
A table tracking recent public consultations announced by the European Medicines Agency and Food and Drug Administration
A table summarising the European Medicines Agency's safety related reviews concerning authorised medicines