All Biologics formulation and stability articles – Page 2
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NewsIpsen strikes €1bn deal to acquire French biotech ImCheck Therapeutics
The move will boost its oncology pipeline, adding a potential first-in-class anti-BTN3A monoclonal antibody for acute myeloid leukaemia.
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NewsMerck & Co starts phase IIb study of tulisokibart in rheumatoid arthritis
The study is one of three to start, along with those in hidradenitis suppurativa and radiographic axial spondyloarthritis.
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NewsPolpharma Biologics splits into biosimilars and CDMO businesses
Contract development and manufacturing services will be provided as Rezon Bio from Poland, with the biosimilars company operating from Switzerland.
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NewsGenmab makes $8bn acquisition to boost late-stage antibody therapy pipeline
The deal will support the biotech in its plans to advance bispecific antibody petosemtamab in multiple oncology indications.
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NewsLilly wins European Alzheimer’s approval for Kisunla after regulatory setbacks
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
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NewsOne-time gene therapy could “transform” Huntington’s treatment landscape
uniQure’s positive topline data “are the most convincing in the field to date” and indicate the gene therapy’s potential disease-modifying effects.
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ArticleEuropean Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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NewsLilly picks Virginia for the first of its four new US manufacturing facilities
The new $5 billion manufacturing site is set to become the company’s first integrated facility for API and drug product manufacturing.
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NewsEuropean generics firm Zentiva sold in $4.8bn private equity deal
Prague-based pharma company is acquired by GTCR from Advent.
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Novartis expands in cardiovascular disease with $1.4bn Tourmaline Bio acquisition
Gains access to potential breakthrough atherosclerotic cardiovascular disease biologic therapy pacibekitug.
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NewsFDA waives trial requirement for Stelera biosimilar, easing the copycat’s path
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
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Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
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ArticleScaling for the GLP-1 revolution - meeting global injectable demand
In this article, Miguel Angel Ortega Sánchez of ROIS explores how the industry is adapting to new delivery formats, device bottlenecks, and strategic partnership models — and why flexibility, compliance, and tech transfer agility are now critical to success.
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ArticleResilient supply, reliable care: safeguarding Europe’s generics in an uncertain world
In this article, Michal Nitka, Senior Vice President, Head of Generics Europe & Global Head OTC, Teva Pharmaceuticals, outlines how policy reform, digital innovation, and manufacturing resilience can secure sustainable access to essential treatments - ensuring generic medicines remain a cornerstone of equitable, reliable care.
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WebinarBest practices for PUPSIT assembly design and operation
This webinar explores the design and implementation of pre use post sterilisation integrity test assemblies (PUPSIT) in sterile filtration processes to ensure regulatory compliance while minimising operational risk.
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Sandoz acquisition to boost in-house biosimilar capabilities
The proposed transaction means Just-Evotec Biologics’ Toulouse site would be used to develop and manufacture Sandoz biosimilars.
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NewsExtension trial demonstrates long-term benefit for Lilly Alzheimer's drug
The new findings support a limited duration dosing approach and highlight the consistent safety profile for Eli Lilly’s antibody drug.
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Boehringer partnership to advance biologic for rare skin condition
The new partnership between Boehringer Ingelheim and LEO Pharma aims to expand treatment access for more patients with generalised pustular psoriasis.
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NewsAI model demonstrates potential for streamlining clinical trials
The novel AI-led approach could accelerate development of Alzheimer’s treatments by reducing related costs.
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NewsNext drug patent cliff to challenge Big Pharma strategy
While the pharmaceutical market is expected to witness strong pricing competition, there is also significant opportunity for biotech companies, research says.