News & Analysis as of

Life Sciences United Kingdom

Hogan Lovells

UK MHRA publishes blueprint for the international recognition of medical devices

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The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure...more

BCLP

Navigating the FemTech regulatory landscape: which rules apply and what are the enforcement priorities?

BCLP on

Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more

Skadden, Arps, Slate, Meagher & Flom LLP

Antitrust in Life Sciences: A Dialogue With Anna Vernet

On March 26, 2024, Skadden hosted a discussion on key developments in antitrust enforcement in the pharmaceuticals and life sciences sectors. ...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Akin Gump Strauss Hauer & Feld LLP

The Road Ahead for Private Equity: Reflections and Predictions

The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more

Goodwin

Q&A with TusPark’s Wei Meng on Life Sciences and Operational Real Estate

Goodwin on

Goodwin Partner Raymond Fang talks with TusPark’s head of UK innovation and real estate, Wei Meng, about building life sciences ecosystems and the operational nature of real estate in the sector....more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Morrison & Foerster LLP

Preparing for Investment (and Success) as an Early-Stage Alternative Protein Business

Our last two alerts in this series covered key considerations for early-stage companies in the alternative protein industry and provided an overview of financing in the alternative protein industry. This alert follows those...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McDermott Will & Emery

International News: Spotlight on Foreign Investment

McDermott Will & Emery on

In this dynamic global landscape, investors have always been required to make savvy, smart choices. This requires navigating through the intricate web of bilateral treaty protection, exploring the vital role these agreements...more

A&O Shearman

UPC Insights: Security for legal costs

A&O Shearman on

The UPC decides that the defendant’s financial situation and location matter. On 30 October 2023, the Munich Central Division of the UPC (the Court) issued an order stating that NanoString must provide security to Harvard...more

McDermott Will & Emery

European Health & Life Sciences Symposium 2023 | Key Takeaways

McDermott Will & Emery on

200+ leading individuals in healthcare, life sciences and private equity gathered at the Shangri-La Hotel in Paris for the European Health & Life Sciences Symposium 2023 to enjoy a day packed with fireside chats, in-depth...more

A&O Shearman

UK CMA issues 'prioritisation statement' to allay competition law fears that prevent combination therapies reaching NHS

A&O Shearman on

The UK Competition and Markets Authority (CMA) has taken the unusual step of issuing a prioritisation statement on cooperation between competitors to make combination therapies available to the NHS. The CMA worked closely...more

Goodwin

UK Authorizes World-First Gene Therapy from Vertex and CRISPR Therapeutics for Blood Disorders

Goodwin on

​​​​​​​Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY...more

McDermott Will & Emery

Lowest-risk Clinical Trials Will Benefit From a New Notification Scheme and a Shorter Period for Application Processing

McDermott Will & Emery on

On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more

A&O Shearman

Antitrust in focus - October 2023

A&O Shearman on

The Foreign Subsidies Regulation (FSR) establishes a new regime, enforced by the European Commission (EC), to regulate subsidies granted by non-EU countries to businesses active in the EU that could distort competition in EU...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

BCLP

Real Estate Outlook 2023

BCLP on

At the beginning of 2023, our real estate subsector leaders shared their insights on what headwinds and tailwinds they expected for the industry in the coming year. As a follow-up retrospective, we asked the subsector leaders...more

McDermott Will & Emery

Investing in Healthcare & Life Sciences - An International Guide to Regulatory and Transactional Issues Across the Sector -...

McDermott Will & Emery on

As macroeconomic forces and geopolitical dynamics continue to shape the M&A and investment climate globally, health and life sciences transactions continue to remain high priority sectors presenting both high growth and...more

Hogan Lovells

UK: a new medical devices regime on the horizon?

Hogan Lovells on

The UK Government has recently made available a draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 (2023 Regs). Although these are far from being in force yet,...more

A&O Shearman

MHRA Corporate Plan 2023-2026: a focus on International Recognition

A&O Shearman on

The Medicines and Healthcare products Regulatory Agency recently published a Corporate Plan outlining their strategic priorities for the next three years. A key area of focus is international recognition, which follows their...more

A&O Shearman

European Commission’s record gun-jumping fine on Illumina serves as warning to merging parties

A&O Shearman on

The European Commission (EC) has imposed a fine of around EUR432 million on genomics company Illumina for closing its acquisition of blood-based cancer test developer GRAIL before the conclusion of the EC’s merger control...more

Hogan Lovells

UK MHRA medical device standstill extension commences

Hogan Lovells on

Today marks the commencement of the legislation that extends the standstill period for EU CE-marked medical devices to continue to be placed on the market in Great Britain (England, Wales and Scotland)....more

A&O Shearman

UK - ICO publishes neurotechnology report flagging the discrimination risks in brain-monitoring technologies

A&O Shearman on

The UK Information Commissioner's Office (ICO) published a report on neurotechnology and released an accompanying statement on 8 June 2023....more

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