news
First oral medicine for postpartum depression approved
The first approved oral treatment that provides rapid symptomatic improvement in postpartum depression (PPD) is expected to be commercially available in the fourth quarter of 2023.
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US Food and Drug Administration (FDA)
news
Adalimumab biosimilars shaping market, research states
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.
news
Harnessing continuous improvement in the CAPA process
In a risk-based framework for implementing a corrective and preventive action (CAPA) process, a continuous improvement approach is proposed as a way to drive higher product quality and improve patient safety.
article
Re-engineering proteins to develop novel immunotherapies
Jessicca Rege of Alkermes provides insights into how protein engineering approaches have led to the development of novel therapies that harness the immune system’s capabilities to fight cancer.
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The future of medical cannabis development in Europe
Dr Mikael Sodergren, Chief Medical Officer at Curaleaf International, discusses the challenges of developing and researching medical cannabis products and how the European medical cannabis ecosystem is well placed to overcome them.
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On the clock: a collaborative approach to advancing adoption of RMM
EPR’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry.
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International regulation: the importance of quality assurance in drug development
Raquera Brown, Executive Director of Quality at Zymeworks offers quality and compliance professionals advice on how to navigate the often-complex regulatory space during development of innovative drugs like antibody therapeutics.
news
FDA approves new cell therapy manufacturing plant
Bristol Myers Squibb has received approval from the US FDA to begin commercial production at its newest cell therapy manufacturing site.
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What gene therapy manufacturers can gain from collaboration
In this article, Neil Almstead, Chief Technical Operations Officer at PTC Therapeutics, shares his view on why collaboration is key to streamlining manufacture of gene therapies.
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Psychedelic medicines: are they gaining traction in Europe?
Carissa Kendall-Windless and Sian Banks of law firm Pinsent Masons discuss the development of psychedelic medicines and the legal and regulatory challenges that must be overcome for psychedelics to become safe and effective treatment options in Europe.
podcasts
EPR Podcast Episode 18 – Embracing continuous manufacturing – Trish Hurter, Lyndra Therapeutics
In this episode Dr Patricia Hurter, CEO of Lyndra Therapeutics, discusses how the pharmaceutical sector can embrace continuous manufacturing. She also shares her tips for women looking to progress their careers in pharma.
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Prioritising for a data-driven 2023
As the pharmaceutical industry continues to face unprecedented challenges, the need for greater regulatory compliance and process efficiency remains at the forefront. Here, Frits Stulp predicts how new waves of digital transformation can help support companies deliver the best possible patient outcomes.
news
FDA approves first treatment for geographic atrophy
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
news
Pre-filled asthma pen approved for self-administration in EU
Tezspire is the first biologic approved in Europe for severe asthma with no phenotype or biomarker limitation, says AstraZeneca EVP.
news
FDA grants priority review of glofitamab for lymphoma
Glofitamab for relapsed or refractory large B-cell lymphoma has been granted priority review by the US Food and Drug Administration (FDA).
