All Therapeutics articles – Page 46
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NewsMHRA regulation overhaul: new scheme for lowest-risk UK clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) states its new scheme enables a more streamlined approach to processing Clinical Trial Authorisations (CTAs) for initial applications in late-stage clinical trials.
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NewsNew acquisition to accelerate microbiome therapeutics manufacture
Clinical development and manufacture of microbiome-based therapeutics is set to be accelerated through Kanvas Biosciences’ new acquisition of key assets from Federation Bio.
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NewsRoche multiple sclerosis subcutaneous injection: late-breaking data
OCREVUS subcutaneous injection was comparable to intravenous (IV) infusion in providing near-complete suppression of multiple sclerosis brain lesions over 24 weeks, Phase III study data shows.
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NewsECNP 2023: new esketamine NS safety data for depression
New safety data for a Phase IIIb study in treatment-resistant depression (TRD), revealed at ECNC 2023, showed that esketamine NS significantly increased the proportion of patients achieving remission compared to quetiapine XR.
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NewsPharma pushes for UK medicine scheme revision
If proposed changes to the UK’s Statutory Scheme for branded medicines is implemented, there will be “a negative impact on new product launches, despite any initial exemption in the first three years,” says Astellas.
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NewsLife Sciences Innovation Day - Accelerating Digital Transformation Ambition
On 18 October 2023, Schneider Electric’s unique event brings together six leading speakers who will explore the future of biotechnology and personalised medicine using AI & digital transformation in life sciences.
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NewsNovel anti-epileptic drug demonstrates efficacy
Research reveals that a new, potassium-channel opening drug has shown an ability to reduce seizure frequency by more than half in certain epilepsy patients.
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NewsMSD medicine accepted for use in Scotland
Scotland is the first European country to accept the HIF-2α inhibitor WELIREG® (belzutifan) for eligible adults with von Hippel-Lindau (VHL) disease.
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NewsBristol Myers Squibb agrees nearly $6bn oncology merger
In an agreed merger with Mirati Therapeutics, Bristol Myers Squibb will gain rights to a best-in-class treatment for advanced non-small cell lung cancer (NSCLC) with a KRASG12C mutation.
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NewsIndia joins mission to harmonise pharmacopoeial standards
As a “major manufacturer of the world’s medicines”, the Indian Pharmacopoeia Commission (IPC) has joined the Pharmacopoeial Discussion Group (PDG) to contribute to the harmonisation of quality standards.
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NewsModerna reveals optimistic data for influenza-COVID-19 vaccine
Strong influenza and COVID-19 immunogenicity compared to approved standalone vaccines has been demonstrated in Moderna’s combination vaccine, interim Phase I/II trial data shows.
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NewsFUJIFILM Diosynth recruits new Quality leader
An ex-Biogen executive has been appointed as CDMO FUJIFILM Diosynth Biotechnologies’ new Chief Quality Officer.
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NewsStem-cell therapy delivers potential in Alzheimer’s
Top-line Phase IIa data has demonstrated an allogeneic stem-cell therapy facilitated a lack of deterioration in cognitive signals in mild Alzheimer’s.
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NewsSanofi and Teva to develop novel IBD treatment
Under a new agreement with Sanofi, Teva could receive up to $1.5 billion for its novel anti-TL1A therapy, a potential best-in-class option for inflammatory bowel disease (IBD).
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ArticleExploring the gene therapy biomanufacturing landscape
In this exclusive Q&A with European Pharmaceutical Review, Sheila Ann Mikhail, co-founder of AskBio and keynote speaker at CPHI Barcelona delves into the current landscape and future potential of the gene therapy sector. She explores strategies for making gene therapies more affordable and accessible, innovations in drug delivery, as ...
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NewsNovartis completes Sandoz spin-off
As a newly independent company, Sandoz will concentrate on developing generic and biosimilar medicines, while its former parent company Novartis plans to drive its business forward with a strategic focus on innovative medicines.
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NewsLilly agrees $1.4 billion radiopharma acquisition
Two late-stage radioligand therapies for oncological indications are planned to be developed through an acquisition agreement between Eli Lilly and POINT Biopharma Global.
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NewsWHO recommends second malaria vaccine
Newly recommended by the World Health Organization (WHO), the new “safe, effective and affordable” malaria vaccine has potential to reduce deaths "by up to a third”.
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NewsIncreasing efficacy in extractables and leachable testing
Researchers have proposed a read-across methodology for pharmaceutical extractables and leachable (E&L) testing as a time-saving alternative to toxicity testing.
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NewsSanofi-Janssen collaboration to advance novel E. coli vaccine
A potential first-in-class extraintestinal pathogenic E. coli (ExPEC) vaccine set to be jointly developed by Sanofi and Janssen, could help to abate a pathogen that is key in driving global antimicrobial resistance (AMR).