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CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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Autoimmune diseases
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European Commission authorises one of first ustekinumab biosimilars in Europe
This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
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BCMA CAR T therapy facilitates potential autoimmune breakthrough
First use of a BCMA CAR T-cell therapy for immune-mediated necrotising myopathy (IMNM), enabled sustained depletion of autoantibodies beyond 18 months, a study shows.
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AstraZeneca to advance haematology cell therapy
The new acquisition grants AstraZeneca rights to a new CAR-T cell therapy with a differentiated manufacturing process that could provide a potential best-in-class blood cancer treatment.
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Developing a first-in-class small molecule drug for inflammatory disease
In this exclusive Q&A, Dr Jenna Brager, Executive Vice President of Drug Development for MyMD Pharmaceuticals® explains to EPR why its oral small molecule drug could transform how TNF-α based diseases are treated.
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Targeting tumours with novel radiopharmaceuticals
In this exclusive Q&A, Dr Jack Hoppin, CEO, and Dr John Babich, Chief Scientific Officer of Ratio Therapeutics share their perspective on the evolving radiopharmaceutical landscape and why radiopharmaceutical therapeutics have significant potential in oncology.
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Merck to develop mAb through $10.8b acquisition
Through a $10.8 billion acquisition, Merck has agreed to buy Prometheus Biosciences to advance development of a novel monoclonal antibody for immune conditions.
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Gilead’s $658.5m immunotherapy collaboration
Gilead will develop immunotherapy products through a $658.5m agreement with EVOQ Therapeutics using EVOQ’s NanoDisc technology.
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Takeda’s $4 billion acquisition to address autoimmune diseases
Takeda will acquire Nimbus Therapeutics for $4 billion and gain rights to its allosteric TYK2 Inhibitor to address multiple immune-mediated diseases.
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$8 million grant awarded to new US stem cell clinic
New US stem cell clinics given an $8 million grant will boost industry collaboration and advance regenerative medicine research, clinical trials and pioneering training.
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Litifilimab reduces skin disease activity in CLE trial
Phase II results suggest litifilimab safely and effectively reduces skin disease activity in cutaneous lupus erythematosus (CLE) patients.
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Machine learning model enables adventitious agent detection in cell cultures
Researchers have developed a rapid, label-free process analytical technology, called the anomaly detection model, to monitor microbial contamination in cell cultures in near-real-time.
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Nearly two years on, how are European pharma supply chains coping with COVID-19?
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
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EMA to assess if Olumiant should be authorised for hospitalised COVID-19 patients
The EMA will conduct an accelerated assessment and issue its decision on whether Olumiant (baricitinib) can be used in hospitalised COVID-19 patients by July.
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A new small molecule drug discovery and development platform for HLA-associated autoimmune diseases
In the arsenal of approved small molecule drugs, effective, genetically-targeted therapies for the treatment of autoimmune diseases are conspicuously scarce. ImmunoMolecular Therapeutics (IM Therapeutics) has developed a paradigm for the discovery and development of new molecular entities as a broad platform for blocking genetic targets that confer risk of disease development…
