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The life sciences sector

The life sciences sector is made up of a broad set of industries, such as pharmaceuticals, medical technology (devices and diagnostics), biotechnology, plant protection and cosmetics. Within each of these industries are many subdivisions or specialisms. For example, within pharmaceuticals there are chemical compounds, active pharmaceutical ingredients, or chemical entities (which are more commonly known as small molecules). There are also biologically derived products used in pharmaceuticals, such as monoclonal antibodies and cell therapies. In addition, there are products at the borderline of pharmaceuticals, eg foodstuffs, which may be processed to have particular designed health benefits.

The highly regulated and highly technical nature of the life sciences industry can give rise to particular issues/challenges when advising on business transactions involving organisations operating in this space. Consequently, lawyers advising on such business transactions need to be alive to and understand the facets of the sector.

Mergers and acquisitions

In recent years, the life sciences sector has experienced significant merger and acquisition (M&A) activity. A number of factors have driven deal flow in the industry, including: progress in developing efficacious therapies, the need for mid-size and larger

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Latest Life Sciences News

Pfizer Takes Aim At Moderna's Leftover MRNA Protections

Law360, London: Pfizer asked an appeals court on 10 July 2025 to revoke surplus patent protections underpinning rival Moderna's mRNA vaccine after getting a key patent tossed.

Medicines for Europe challenges EU levy on pharmaceuticals under wastewater directive

Medicines for Europe has applied to intervene in legal proceedings before the EU General Court challenging the EPR scheme in the recast Directive 91/271/EEC (Urban Wastewater Treatment Directive (UWWTD)) . The group argues the scheme imposes disproportionate costs on the generic medicines sector based on flawed toxicity data and threatens patient access and supply. The case questions the legality and scientific basis of EU environmental regulation impacting pharmaceuticals.

EMA publishes first AI Observatory report to guide safe AI use in medicines lifecycle

The European Medicines Agency (EMA) has published its first AI Observatory report and supporting documents on 10 July 2025. The report compiles regulatory experience from across the EU network on the use of artificial intelligence (AI) in the medicine lifecycle, including automation, clinical trial support, and pharmacovigilance. It also includes a horizon scanning analysis of AI opportunities and challenges. The findings will inform EMA’s multi-annual AI workplan and support preparation for the EU AI Act.

MHRA announces alignment with common specifications for high-risk IVD devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to amend the Medical Devices Regulations 2002, SI 2002/618 to incorporate common specifications for high-risk in vitro diagnostic (IVD) devices. The changes include repealing Coronavirus Test Device Approvals (CTDA) regulations and introducing an accelerated approval process for CE-marked Coronavirus Test Devices. This decision follows strong support from consultation respondents for replacing the CTDA process with the common specifications. The changes aim to ensure that IVD devices meet high performance standards supported by clinical evidence and improve patient care and public health outcomes.

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