All Biologics formulation and stability articles – Page 4
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NewsAlzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
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NewsNovartis nets potential first-in-class medicine in new cardiovascular acquisition
The potentially multi-billion-dollar deal strengths Novartis’ late-stage pipeline for cardiovascular therapies, signalling advancement of novel treatments for heart disease.
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NewsBiologic could reduce treatment burden for children with haemophilia A
New data suggests that once-weekly prophylaxis bispecific antibody treatment could provide an efficient and convenient option for young patients with haemophilia A.
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NewsCHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
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ArticleBiosimilar medicines: the intersection of access, affordability, and innovation
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.
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NewsLilly IBD biologic receives expanded US approval
The drug is the first biologic in over 15 years to have disclosed two-year Phase III efficacy data in Crohn's disease at the time of approval.
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ArticlePotential blockbuster drugs to watch in 2025
Eleven drugs are poised to make waves in the pharmaceutical industry in 2025, according to the annual report.
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NewsFDA issues first recommendations on AI for drug development
The new US Food and Drug Administration (FDA) guidance will enhance credibility of AI models in drug and biological product regulatory submissions.
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NewsRoche to advance potentially best-in-class antibody drug conjugate
As part of the collaboration and license agreement, Innovent Biologics, Inc. could receive up to $1 billion, subject to developmental success of the biologic candidate.
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NewsBristol Myers Squibb licenses amyloid-beta antibody programme
The new agreement between Bristol Myers Squibb and BioArctic is set to advance development of anti-amyloid-beta antibody treatments, which have shown symptomatic benefit in Alzheimer's.
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NewsAntibody drug has promise as “next frontier” in inflammatory bowel disease
With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease (IBD), say Teva Pharmaceuticals and Sanofi.
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NewsInnovative biologic prefilled syringe approved in EU
The new treatment option provides a convenient alternative to currently available vials of the bispecific antibody for EU patients with common vision conditions.
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ArticleTargeting ovarian cancer with a novel antibody therapeutic
Christina Pelizon, International Medical Affairs Head for Oncology at AbbVie discusses the significance and impact of the European Commission’s approval last month of Elahere® (mirvetuximab soravtansine) to treat ovarian cancer.
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NewsNew mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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NewsStudy proposes system to produce endotoxin-free recombinant proteins
The system is distinguishable from other bacterial expression systems and can be applied in scenarios where minimal endotoxin contamination is an issue, according to the research.
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NewsSanofi investment to enhance antibody bioproduction in France
This bioproduction investment in Lyon, France supports Sanofi in its goals to lead in the immunology sector.
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NewsBioNTech oncology acquisition to advance bispecific antibodies
The acquisition is set to strengthen BioNTech’s capabilities in development and manufacture of next-generation bispecific antibodies.
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WebinarWhen innovative formulations cloud sterility testing
Webinar presented by Miriam Guest, Senior Principal Scientific Advisor at Charles River, to explore how ATP-bioluminescence outperforms traditional sterility testing in complex matrices.
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NewsACG 2024: J&J data reveals new Crohn's treatment option
More patients given subcutaneous induction and maintenance treatment with Johnson & Johnson’s biologic obtained clinical remission at 48 weeks, compared to placebo, Phase III data showed.
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NewsTrial highlights potential next-gen biologic for lung cancer
Preliminary results from an ongoing trial of a novel monoclonal antibody have confirmed favourable efficacy and safety in recurrent extensive-stage small cell lung cancer (SCLC).