news
NICE partners with health technology assessment bodies
Five health technology assessment (HTA) bodies will collaborate with NICE to help resolve regulatory and digital health technology challenges.
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Regs & Legs
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Pilot to support ATMP research and development
Five academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) will benefit from the European Medicines Agency’s (EMA) scheme.
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Sharing data on human tissue availability across EU
The Council of Europe encourages EU Member States to share tissue and cell availability data to support donation access and State self-sufficiency.
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Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
news
Is TEE the key for novel antibiotics?
Research suggests a Transferable Exclusivity Extension (TEE) system is “the only existing option capable of incentivising antibiotic R&D in a sustainable manner” for Europe.
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New ethical guidance for paediatric clinical trials
New draft guidance by the US Food and Drug Administration (FDA) evaluates the ethics of children participating in clinical studies.
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On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
news
Ultomiris for generalised myasthenia gravis
The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.
whitepaper
Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
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Using RWE in rare disease drug development: effective innovations with historical controls
With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
news
Evusheld COVID-19 therapy approved in EU
Evusheld becomes first and only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe.
news
EMA approves biosimilar interchangeability in EU
Biosimilar medicines can now be interchanged with their reference medicine or an equivalent biosimilar, says European Medicines Agency (EMA).
news
First bispecific antibody approved in EU to combat leading causes of vision loss
Roche’s Vabysmo® (faricimab) has been approved in Europe as a four-monthly treatment for wet age-related macular degeneration and diabetic macular oedema.
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Is localisation the answer for pharmaceutical supply chain resilience?
Highlighting the findings of a recent supply chain report, EPR’s Hannah Balfour discusses measures pharmaceutical suppliers may adopt to establish demand- and crisis-resistant supply chains. Commenting on the findings, Ernst & Young Global Limited colleagues Famke Krumbmüller, Derron Stark and Olaf Zweig elaborate on the impact and lessons learned through…
