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Key developments in pharmaceutical manufacturing – September 2023
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
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Clinical Trials
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Navigating challenges in HPAPI development and manufacturing
12 October 2023 | By Thermo Fisher Scientific (Patheon)
HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.
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MHRA 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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Roche 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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ECNP 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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Pharma 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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Bristol 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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Moderna 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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Stem-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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Lilly 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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WHO 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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Sanofi-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).
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EMA validates MAA for novel telomerase inhibitor
Following European validation of its Marketing Authorisation Application (MAA), imetelstat has potential to become a standard of care in lower risk myelodysplastic syndromes (MDS), according to Geron’s CEO.
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Will novel antibiotic become front-line for C. difficile?
Based on positive Phase II data, the first-in-class antibiotic candidate ibezapolstat for C. difficile is expected to advance to Phase III trials more quickly.
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FDA approves first-in-class antidepressant
The first antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor has been approved for major depressive disorder (MDD) by the US Food and Drug Administration (FDA).
