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Lilly 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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Potential 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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FDA 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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Roche 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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Bristol 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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Antibody 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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Innovative 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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BioNTech 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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ACG 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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Trial 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).
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Innovative 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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GSK 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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Novartis 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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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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Genmab 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.
