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Regs & Legs

Climate crisis and technological innovation shaping pharmaceutical water market

14 February 2025 | By Catherine Eckford (European Pharmaceutical Review)

As a significant water consumer to enable production of high-quality medicines, this demand brings both challenges and opportunities for the pharmaceutical industry up to 2033, research suggests.

news

EU Urban Wastewater Treatment Directive may compromise EU medicine availability

13 February 2025 | By Catherine Eckford (European Pharmaceutical Review)

The directive could lead to nearly €1 billion in additional costs for pharmaceutical companies in Finland alone, states Orion Corporation.

news

First-of-a-kind EU approval granted for oral small molecule

12 February 2025 | By Catherine Eckford (European Pharmaceutical Review)

The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.

news

AstraZeneca cancels £450m Liverpool vaccine facility expansion

10 February 2025 | By European Pharmaceutical Review

Under growing global competition, this development highlights potential challenges for the UK to uphold large-scale pharmaceutical investments.

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Unlocking intellectual property potential in European pharma

6 February 2025 | By Joshua Harris (Burford Capital)

Joshua Harris, Director, Burford Capital, discusses how patent monetisation, including systems like the Unified Patent Court (UPC), enables European pharmaceutical companies to remain competitive and ensure R&D investment and innovation.

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Novel drug approved for diabetes-related vision loss

6 February 2025 | By Catherine Eckford (European Pharmaceutical Review)

The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.

news

Draft regulatory guidance on personalised cancer therapies published

5 February 2025 | By Catherine Eckford (European Pharmaceutical Review)

The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.

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MHRA approves SARCLISA for newly diagnosed multiple myeloma

4 February 2025 | By European Pharmaceutical Review

SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.

news

CHMP meeting highlights – January 2025

3 February 2025 | By Catherine Eckford (European Pharmaceutical Review)

In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.

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NICE recommends gene therapy for severe sickle cell disease

31 January 2025 | By Catherine Eckford (European Pharmaceutical Review)

The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.

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UK enhances ILAP to accelerate access to innovative medicines

31 January 2025 | By European Pharmaceutical Review

The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.

article

Biosimilar medicines: the intersection of access, affordability, and innovation

31 January 2025 | By Julie Maréchal-Jamil (Medicines for Europe)

In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.

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New guidance to aid cost-effectiveness analysis of new drugs

17 January 2025 | By Catherine Eckford (European Pharmaceutical Review)

The report aims to support development of economic models for health technology assessment (HTA) decision making, as there has been “little change in guidance on the use of surrogate endpoints in HTA since 2018”.

news

Lilly IBD biologic receives expanded US approval

16 January 2025 | By Catherine Eckford (European Pharmaceutical Review)

The drug is the first biologic in over 15 years to have disclosed two-year Phase III efficacy data in Crohn's disease at the time of approval.

whitepaper

NSF Launches ‘Compliance Unlocked’ Podcast Series

15 January 2025 | By

NSF invites pharmaceutical professionals to tune in to its new groundbreaking podcast series “Compliance Unlocked” and join the conversation on critical industry issues.

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