News
This week's edition of Life Sciences weekly highlights includes news analysis on the Court of Justice’s decision to introduce an invention test for...
16th Jan
News
The MHRA has released a collection of guidance documents to support medical device manufacturers implement the new Post-market surveillance (PMS)...
16th Jan
News
Life Sciences analysis: The Patents Court has confirmed the UK IPO Hearing Officer’s decision to refuse to grant two SPCs for combination products in...
16th Jan
News
The Highly Specialised Technologies (HST) Programme evaluates technologies for ultra-rare diseases (defined in NICE strategic principles, and...
15th Jan
News
The European Medicines Agency (EMA) has announced its readiness to support the implementation of Regulation (EU) 2021/2282 EU (the new regulation on...
15th Jan
News
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has adopted a new version of its...
15th Jan
News
EU Law: Ravi Srinivasan and Graham Lewis, partners, and James Egleton and James Smythies, associates, at J A Kemp discuss the decisions in Joined...
13th Jan
News
New EU-wide rules on Health Technology Assessment (HTA) become effective from 12 January 2025. Regulation (EU) 2021/2282 (the HTA Regulation)...
10th Jan
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The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on the International Council for Harmonisation (ICH)...
10th Jan
News
IP analysis: The European Patent Office (EPO) regularly applies the problem and solution approach when deciding whether an invention involves an...
9th Jan
News
The European Federation of Pharmaceutical Industries and Associations (EFPIA), along with AESGP and Medicines for Europe, has proposed a phased...
9th Jan
News
The European Commission has announced that Member States have endorsed a new strategy for the COMBINE programme, aimed at streamlining combined...
9th Jan
News
This week's edition of Life Sciences weekly highlights includes news analysis by Freshfields on MHRA’s plans for reforming the medical devices...
9th Jan
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The Medical Device Coordination Group (MDCG) has released two revised documents providing updated guidance for the medical device industry.
8th Jan
News
The U.S. Food and Drug Administration (FDA) has released draft guidance on artificial intelligence (AI)-enabled device software functions, focusing on...
8th Jan
News
Life Sciences analysis: The UK Medicines and Healthcare products Regulatory Agency (MHRA)’s plans for reforming the medical devices regulatory...
7th Jan
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EU Law analysis: The Unified Patent Court’s (UPC) First Panel of the Court of Appeal (CoA) sitting with only three Legally Qualified Judges, has...
6th Jan
News
MLEX: OpenAI, X, Google and Meta will be able to use legitimate interests as a legal basis for processing personal data for developing and deploying...
19th Dec
News
This week's edition of Life Sciences weekly highlights includes news analysis on emerging trends in the Unified Patent Court. Also included, is news...
19th Dec
News
The Advertising Standards Authority (ASA) has this week upheld 20 complaints, and informally resolved a further 14 complaints, for misleading...
18th Dec