All Biologics formulation and stability articles – Page 2
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ArticleA careful calibration: balancing small molecule needs and biologic innovation
CDMOs weigh up how to meet manufacturing demands across oral solid doses, monoclonal antibodies, ADCs and beyond.
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NewsEuropean Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
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NewsTakeda expands its ADC and immuno-oncology pipeline as Innovent deal closes
The $11bn collaboration with the Chinese biopharma company gives Takeda the rights to several next-generation candidates.
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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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WebinarRealising autonomous pharmaceutical operations
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AstraZeneca furthers US manufacturing commitment with $2bn Maryland investment
The move is part of biopharma's $50 billion pledge to US medicines manufacturing and R&D.
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First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
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MHRA approves Leqembi IV maintenance as additional Alzheimer’s option
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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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.