news
First continuous mRNA manufacturing platform to be developed
Design of the world’s first continuous mRNA manufacturing platform, an $82 million, three-year, FDA-funded project aims to help accelerate development of mRNA technologies.
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R&D
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NIH spending for drugs approved 2010-2019 lower than industry spending, study finds
The first article to broadly assess the US National Institutes of Health (NIH)'s financial contribution to clinical development of new drugs has been published.
news
Roche agrees to develop oncology small molecule inhibitor
An agreement to obtain a global license for KSQ Therapeutics’ small molecule USP1 inhibitor, which has potential to treat a variety of cancers, has been signed by Roche.
news
How can PAT help advance biologics manufacturing?
Lonza’s Associate Director of R&D has offered insight on implementing process analytical technology (PAT) into biologics manufacturing using real-world examples.
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Ten-minute subcutaneous injection shows promise for MS
A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
article
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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WHO prequalifies meningitis conjugate vaccine
Prequalification by the World Health Organization (WHO) for the first conjugate vaccine to prevent meningitis caused by meningococcal group X could help “finally end all meningococcal meningitis epidemics in Africa”.
news
Safety analysis published for C. diff biotherapeutic
The largest safety evaluation of any microbiota-based live biotherapeutic includes data for up to two years for the first approved microbiome-based treatment for recurrent Clostridioides difficile (C. diff).
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IFPMA reveals new CEO leadership lineup
CEOs from Pfizer, Roche and Daiichi Sankyo will join the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)’s new CEO leadership team.
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Post-approval R&D key in advancing oncology treatments
The Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted in a new report five R&D mechanisms that could facilitate full clinical value of oncology treatments after initial approval from the US Food and Drug Administration (FDA).
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WuXi Biologics proposes spin-off to support bioconjugate development
WuXi Biologics proposed spin-off and a separate HKEX listing of its subsidiary WuXi XDC means the company will be able to better capture the fast-growing global bioconjugate market.
news
Bispecific antibody approved in Europe for DLBCL
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
whitepaper
ebook: Accelerate the development of your small molecule
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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.
