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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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Research & Development (R&D)
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Harnessing small molecules to treat chronic inflammatory diseases
Dr Sheldon Sloan, MBE, Chief Medical Officer, Abivax, shares why the company’s microRNA small molecule treatment could provide long-term efficacy for ulcerative colitis patients, as well as the outlook for using small molecule-based drugs in autoimmune and chronic diseases.
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New Phase III data for hidradenitis suppurativa biologic released
The IL-17A and IL–17F inhibitor demonstrated positive efficacy and safety in adults with moderate-to-severe hidradenitis suppurativa, new data shows.
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Innovative analytical method for quality control of nanomedicines
The research on nanomedicines investigated the intrinsic radiothermal emission of nanodrugs using a novel method.
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Development of novel water-soluble inks for 3D-printed polypills
An “innovative formulation and printing process” utilising 3D-printing could lead to scalable batch production of personalised pharmaceutical tablets, research suggests.
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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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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 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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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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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.
