All Biologics formulation and stability articles – Page 9
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WhitepaperProduct hub: Choosing the right tool for method screening and process optimisation
CIM® Monolithic Well Plates combine the advantages of monolithic chromatography with the convenience of a standard well plate format. They ensure robustness and reliable results, making them ideal for screening multiple chromatographic conditions simultaneously.
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NewsLong COVID study expanded across Europe
If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.
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NewsNew Amgen immunotherapy could treat common solid tumour
With demonstrated benefit in anti-tumour activity and overall survival in patients with small cell lung cancer, Tarlatamab could provide a new third-line option, a Phase II study suggests.
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NewsBoehringer Ingelheim to advance bacterial cancer therapeutics
Through a new acquisition, Boehringer Ingelheim will have rights to a platform that enables the design of immuno-oncology combination therapies in one single agent.
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NewsBRUKINSA® granted significant EU approval in follicular lymphoma
The first and only Bruton’s tyrosine kinase (BTK) inhibitor approved for follicular lymphoma in the EU, now has the broadest label of any medicine in its class globally.
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NewsTrial for novel CGRP migraine medicine gleans positive results
The first pill designed to directly block calcitonin gene-related peptide (CGRP), a protein released during a migraine attack, has demonstrated positive evidence in AbbVie’s trial investigating its efficacy in the prodrome phase.
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NewsRegional inequalities threatening Europe’s biosimilars market
A new report reveals that low biosimilar adoption in certain European regions is impacting biologic medicine access for patients.
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NewsSandoz mobilises critical medicine production in Europe
Alongside its new biosimilar facility, Sandoz’s new penicillin production process will help secure European-based antibiotic supply.
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NewsFirst chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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ArticleEuropean Pharmaceutical Review Issue 5 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
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NewsGilead reveals positive data for potential first-line adenocarcinoma treatment
The only Fc-silent anti- T-cell immunoreceptor with Ig and ITIM domains (TIGIT) antibody in Phase III for upper GI adenocarcinomas could be the first to market for these cancers.
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NewsFDA approves first Stelara biosimilar, Wezlana
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
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NewsEuropean approval for third adapted COVID-19 vaccine
The European Commission has authorised the first protein-based adapted vaccine for COVID-19.
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NewsSustainable biosimilar competition in Europe: can it be achieved?
The Biosimilar Medicines Group has reflected on a new report by IQVIA that outlines factors for achieving sustainable levels of biosimilar competition in Europe.
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ArticleAntibody-drug conjugates: paving the future of oncology clinical development
Dr Mark Rutstein, Senior Vice President, Head of Oncology Clinical Development at Daiichi Sankyo, highlights key data about the company’s antibody-drug conjugate (ADC) being investigated for breast and lung cancer, and shares insight into why ADCs could replace current standards of care in oncology.
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NewsESMO 2023: Janssen reveals data for intravesical delivery system
Phase IIb study results show evidence of sustained, durable complete responses beyond one year with an intravesical gemcitabine delivery system for a high-risk bladder cancer.
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NewsRoche to gain rights to novel antibody for IBD
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
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NewsSanofi treatment could slow type 1 diabetes progression
New Sanofi Phase III trial data adds to evidence of the treatment potential for the first disease modifying therapy in type 1 diabetes.
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Whitepaper
Application note: Low Endotoxin Recovery case study
This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
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WebinarNavigating challenges in HPAPI development and manufacturing
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.