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Ipsen agrees new oncology licensing deal
The agreement relates to an innovative therapeutic for the most common paediatric brain cancer, where outside the US, there is no approved targeted treatment for certain patients.
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BeiGene enhances biologic capability with new US facility
Inauguration of the new facility supports BeiGene’s goal to develop affordable and accessible cancer treatments for patients globally.
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Generic HIV raltegravir medicines approved
The UK Medicines and Healthcare products Regulatory Agency (MHRA)’s novel approval means that certain patients with HIV have more options for treatment.
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Pharma responds to 2024 UK General Election
The Association of the British Pharmaceutical Industry (ABPI) and Drug Research Safety Unit (DRSU) assert the importance of partnership and collaboration to support the pharmaceutical industry under the new UK government.
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CHMP meeting highlights – June 2024
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
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Innovative small molecule shows promise in obesity
The GLP-1 receptor agonist demonstrated good safety and tolerability in both healthy and overweight/obese adult participants, the Phase I study found.
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New draft guidance promotes diversity in clinical trials
FDA’s new draft guidance follows the new requirement for clinical study sponsors to submit Diversity Action Plans, eg, when submitting their investigational new drug (IND) application.
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Drug approval roundup – May/June 2024
This article highlights some of the key regulatory approvals granted in May and June in the EU and US so far this year, including for oligonucleotide and biologic therapies.
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New US fill finish facility receives $4.1 billion investment
Novo Nordisk plans to allocate $6.8 billion towards production to expand its overall US manufacturing capacity.
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New multiple sclerosis treatment option granted in EU
The newly authorised formulation of the anti-CD20 therapy provides certain multiple sclerosis patients with another treatment option comparable to intravenous infusion.
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Big potential for small molecule drugs in cancer treatment
With recent recommendation of Takeda’s fruquintinib by the European Medicines Agency (EMA), EPR spoke to Dr Sebastian Stintzing, Professor of Medicine, Head of the Department of Hematology, Oncology, and Tumor Immunology (CCM) of The Charité University Hospital in Berlin and investigator on the FRESCO-2 trial, to find out more about…
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AbbVie to advance TL1A antibody for IBD
The new, potentially multi-billion-dollar deal will help bring a next-generation therapy to patients with inflammatory bowel disease (IBD), an autoimmune condition.
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Innovative radioligand manufacturing facility inaugurated
Following advancements at a similar European facility, the new manufacturing facility in the US is set to produce lead-212 radioligand therapies.
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First-in-class telomerase inhibitor approved for blood cancer
The FDA’s regulatory approval of the telomerase inhibitor is welcome, considering the high unmet need for many lower-risk myelodysplastic syndromes (LR-MDS) patients, according to Geron.
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Advancing targeted treatments for multiple myeloma
Edmond Chan, Senior Director, EMEA Therapeutic Area Lead, Haemato-Oncology, Johnson & Johnson Innovative Medicines, offers insight into the promising evidence of cell therapies and biologic-based treatments for patients with multiple myeloma.
