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Sanofi releases new data for innovative oral asthma treatment
New findings from a Sanofi trial highlight promise for the potential first advanced oral treatment for moderate-to-severe asthma.
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Biopharma
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Progressing personalised cell therapies in oncology
Dr Imran Khan, PhD, Vice President, Medical Affairs, Hematology, Johnson & Johnson Innovative Medicine discusses the major benefits and current challenges of CAR-T cell therapies, as well as the potential of the company’s novel BCMA-targeted treatment for multiple myeloma.
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European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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European authorities recognised for leading medicine regulatory oversight
Expansion of the WLA framework means that the largest number of regulatory agencies for medical products are approved as WHO Listed Authorities.
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MSD collaboration to drive development of solid tumour combination therapy
The EGFR immune engager in combination with pembrolizumab is expected to be administered to the first patients in late 2024.
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Novel biologic could offer ulcerative colitis symptomatic remission
Johnson & Johnson’s selective IL-23 inhibitor demonstrated clinically meaningful improvements compared to placebo in ulcerative colitis, new study data shows.
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UK clinical trial regulation may support haemophilia treatment access
The new Notification scheme by the MHRA helps to reduce the time it takes for the lowest-risk clinical trials to commence, while maintaining patient safety.
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AstraZeneca announces $1.5b ADC manufacturing facility
The new manufacturing facility for antibody drug conjugates (ADCs) will be designed to have zero carbon emissions when operational, AstraZeneca stated.
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FDA approves Amgen T-cell engager for small cell lung cancer
Amgen’s Imdelltra™, previously known as tarlatamab, is approved for the treatment of adult patients with advanced small cell lung cancer.
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GSK pledges £45m to support global AMR prevention
The CEO of GSK shared that the company is “proud to be a founding partner, and hope others will join us to support this urgent priority” in tackling AMR.
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New EVP, Teva Global Operations appointed
The new Executive Vice President of Teva Global Operations will bring “significant experience at every stage of the manufacturing and supply process” to his new role, the company asserted.
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Insights into AstraZeneca’s MANDARA Phase III data
In this Q&A, Dr Michael Wechsler, Professor of Medicine, Director of the National Jewish Health (NJH)/Cohen Family Asthma Institute, reveals details of the data from the MANDARA Phase III trial, showing remission is achievable in EGPA with Fasenra.
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Ensuring sterility of a novel anti-VEGF bispecific antibody
Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.
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Cell therapy could help curb progression of heart failure
New clinical trial data demonstrates the potential for a stem cell treatment as a cardiac regenerative therapy.
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Takeda agrees to develop active immunotherapy for Alzheimer’s
As part of the agreement, AC Immune SA will be eligible for an option exercise fee and extra potential milestones of up to approximately $2.1 billion from Takeda.
