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The global central nervous system (CNS) therapeutics market is forecast to increase from USS80.25 ([euro]74.7 billion) in 2023 to US$106.19 billion ([euro]98.78 billion) by 2031, growing at a compound annual [...]

Over the past two decades, 32 cell and gene therapies (CGTs) have been approved by the regulatory authorities worldwide, and more than 2000 novel products are under clinical investigation (1). [...]

In February 2024, the National Institute for Health and Care Excellence (NICE) recommended AbbVie's Tepkinly (epcoritamab) as the first injectable bispecific antibody for certain blood cancers (1). Unlike existing chimeric [...]

Belgium-based Orionis Biosciences is a clinical-stage life science company developing conditionally acting medicines for cancer and other diseases. Its pipeline includes molecular glue drug modalities and targeted cytokine immunotherapies. Its [...]

Germany's Medical Research Act allows pharmaceutical companies to keep drug prices confidential. On 3 July 2024, the Health Committee of the Bundestag amended and approved the Federal Government's Medical Research [...]

Ariceum Therapeutics, a private biotechnology company, based in Germany, is focused on developing novel drugs for systemic targeted radiation therapy (STRT) for hard-to-treat cancers. The name Ariceum is an anagram [...]

On 3 May 2024, the European Medicines Agency (EMA) initiated a public consultation to review draft recommendations published in its reflection paper on 'the use of real-world data (RWD) in [...]

In December 2021, the European Parliament (EP) passed new legislation, European Union regulation 2021/2282, which amended directive 2011/24/EU and substituted the parallel evaluations of clinical data conducted by multiple country-specific [...]

For several years, manufacturers have been developing organs-on-a-chip (OoC) technology, whereby engineered or natural tissues are grown inside microfluidic chips allowing them to maintain tissue-specific functions. Today, OoCs encompass an [...]

On 1 Jan 2024, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) launched its new International Recognition Procedure (IRP) (1). This new procedure replaces the European Commission's Decision [...]

The EHDS aims to increase access to health data, but how will it impact pharma? In May 2022, the European Commission (EC) proposed the introduction of a European Health Data [...]

The United Kingdom (UK) 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) will end on 31 Dec. 2023. The UK's 2019 VPAS succeeded several Pharmaceutical Price Regulation Schemes [...]

On 4 Sep. 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) issued detailed guidance on the new International Recognition Procedure (IRP) for medicines manufacturers, [...]

TILT Biotherapeutics (TILT) is a Finland-based private biotechnology spin-out from the University of Finland focusing on the development of cancer immunotherapies utilizing oncolytic viruses encoded with a variety of cytokines [...]

On 26 April 2023, the European Medicines Agency (EMA) published two legislative proposals--a new Regulation 2023/0131 and a new Directive 2023/0132 to replace the current European Union (EU) regulatory framework [...]

On 6 Feb. 2023, the European Medicines Agency (EMA) issued new European Union (EU) guidance for drug developers regarding the conduct of paediatric investigation plans (PIPs), particularly when clinical information [...]

For more than a decade, manufacturers have been exploring new ways to improve the efficiency of cell therapy production to make it more cost-effective and accessible to those in need. [...]

The current European Union (EU) regulatory system was established in 1995, and the European Medicines Agency (EMA) works with the European Commission (EC) across 27 member states to ensure the [...]

The unitary patent (UP) will build on European Union (EU) patents granted by the European Patent Office (EPO) under the rules of the European Patent Convention (EPC) (1). This system [...]

While randomized controlled trials (RCTs) remain the gold standard for evidence-based medicines to achieve regulatory approval, interest in the use of real-world evidence (RWE) to support regulatory decision-making is growing [...]

On 31 Jan. 2022, the European Union (EU) initiated the three-year transition for member states to submit clinical trials under a new legal framework Clinical Trial Regulation 536/2014 (EU-CTR) which [...]

The Digital Therapeutics Alliance (DTA) defines digital therapeutics (DTx) as products that deliver: 'evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a [...]

The article focuses on the challenges of making cell and gene therapies more cost-efficient amidst high manufacturing costs and complexity. Topics include the shift towards automated, closed-system manufacturing to reduce costs and errors, advancements in specific platforms like Lonza's Cocoon and Ori Biotech's IRO for scalable production, and ongoing efforts to improve cost-effectiveness in cell therapy manufacturing.