All Biologics formulation and stability articles – Page 5
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ArticleDeveloping donanemab - balancing cost versus benefit
This article summarises recent regulatory developments surrounding the Alzheimer’s treatment donanemab and considers the future therapeutic market for this disease.
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NewsEli Lilly secures MHRA authorisation for Alzheimer's treatment
Authorisation in Great Britain means eligible Alzheimer's patients can access the treatment, which is part of a new class of amyloid targeting therapies.
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ReportPharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
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NewsInnovative medicine production site inaugurated in France
Sanofi’s novel manufacturing unit in France shortens production timelines and enables rapid changes in production capacities for medicines such as biologics and vaccines.
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NewsGSK ultra-long-acting biologic shows Phase III potential
The treatment, being evaluated for severe asthma, is the first ultra-long-acting biologic to be evaluated in Phase III trials.
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NewsNovartis collaboration to innovate subcutaneous drug delivery
The multi-target biologic-focused agreement could enhance treatment convenience by improving subcutaneous administration options for patients.
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News
AstraZeneca investment to increase biologic capacity in Sweden
The planned expansion is set to strengthen AstraZeneca’s capability to manufacture biologic medicines for patients globally.
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NewsAlzheimer’s drug milestone “bittersweet” for certain patients
The first new dementia medicine to be licensed in over two decades shows for first time, that the course of Alzheimer disease can be modified and slow cognitive decline.
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NewsGenmab appoints new EVP and Chief Technology Officer
The new member of Genmab’s Executive Committee brings over 30 years of international biopharmaceutical experience to the role.
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ArticleTargeted therapies for chronic lymphocytic leukaemia in an evolving treatment landscape
Dr Mehrdad Mobasher, Chief Medical Officer for Hematology, BeiGene, discusses the evolution of therapies for chronic lymphocytic leukaemia (CLL), the promise of targeted treatments and what could be on the horizon of the therapeutic landscape for this disease.
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NewsFirst-in-class therapy approved for chronic skin disease
The biologic treatment targets a key driver of prurigo nodularis, with trial data demonstrating improved itch as well as skin nodules for patients with the condition.
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NewsMSD set to acquire novel antibody for B-cell malignancies
The next-generation B-cell depletion biologic therapy has demonstrated promise in B-cell malignancies and autoimmune diseases.
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NewsDownstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
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ArticleAlzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
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NewsAchieving VLP continuous production with digital twins
Utilising a digital twin for an advanced process control strategy facilitates additional productivity gains of 20 percent at 99.9 percent reliability, the authors shared.
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NewsBeiGene enhances biologic capability with new US facility
Inauguration of the new facility supports BeiGene’s goal to develop affordable and accessible cancer treatments for patients globally.
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NewsUtilising naturally occurring endotoxins in recovery studies
The research aimed to address concerns from regulatory agencies about accepting low endotoxin recovery studies that use a naturally occurring endotoxin analyte.
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ArticleUncovering the potential of ADCs to target tumours
Antibody drug conjugates (ADCs) are set to play a pivotal role in the future of oncology, thanks to their potential to offer targeted treatments with a lower risk of side effects. Here, Mary Jane Hinrichs, Senior Vice President of Early Development at Ipsen, examines how ADCs could transform treatment options ...
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NewsDigital simulations could advance nanoparticle drug delivery
Findings from the mathematical model could support development of personalised treatments, the research suggests.
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NewsCHMP meeting highlights - June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.