article
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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US Food and Drug Administration (FDA)
article
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.
article
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.
article
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.
article
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).
news
FDA approves first capsid inhibitor for HIV
Gilead’s Sunlenca (lenacapavir) is the first capsid inhibitor to be FDA-approved for treating HIV-1.
article
Psychedelic research: evaluating the fast-evolving regulatory roadmap
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
news
FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
news
Pluvicto™ offers survival benefits for metastatic prostate cancer
The PSMA-targeted radioligand is first to significantly improve radiographic progression-free survival for PSMA–positive metastatic castration-resistant prostate cancer, shows study.
news
First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
