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First nasal spray for treatment of anaphylaxis approved by FDA

Ars pharmaceuticals has been granted approval by the us food and drug administration (fda) for their epinephrine nasal spray, neffy, to be used as treatment of type 1 allergic reactions including anaphylaxis.

5 September 2024Europe
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FDA approves drug for primary biliary cholangitis

Accelerated approval has been granted for Gilead science’s livdelzi (seladelpar) to treat primary biliary cholangitis (pbc) by the US Food and Drug Administration (FDA).

5 September 2024Europe
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CHMP gives positive opinion for Merck’s KEYTRUDA for unresectable or metastatic urothelial carcinoma

Merck (known as MSDoutside of the US and Canada) has announced that its anti-pd-1 therapy, in combination with padcev (enfortuman vedotin-ejfv), has received a positive opinion from the European Medicines Agency (EMA)

5 September 2024UK News
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Clinical trials for personalised cancer vaccine used to tackle aggressive brain tumours in young

Researchers at the UCLA Health jonsson comprehensive cancer center have announced that they are launching a first-of-its-kind clinical trial to evaluate the safety and effectiveness of a cancer vaccine. The vaccine targets h3 g34-mutant diffuse hemispheric glioma, an aggressive brain tumour typically found in adolescents and young people.

5 September 2024Europe
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European Commission approves combination chemotherapy for treatment of advanced EGFR-mutated

This month, Janssen-Cilag international, part of johnson & johnson (j&j) has announced that the European Commission (EC) has approved a combined treatment of rybrevant (amivantamab) and chemotherapy (carboplatin and pemerexed) for the treatment of non-small cell lung cancer (nsclc) with an epidermal growth factor receptor (EGFR).

5 September 2024Europe
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Adaptimmune receives US FDA Accelerated Approval for engineered cell therapy for a solid tumour

Adaptimmune therapeutics has announced that the US Food and Drug Administration (FDA) has given accelerated approval for tecelra (afamitresgene autoleucel), the first engineered cell therapy for a solid tumour cancer approved in the US.

5 September 2024Europe
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Johnson & Johnson’s MedTech announce orthopaedics receives 501K clearance from FDA

Orthopaedics branch of Johnson and Johnson Medtech, Depuy Synthes, has announced that their surgical robotics system velys active has received 501k clearance from the US Food and Drug Administration (FDA).

5 September 2024Europe
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Merck and Daiichi Sankyo expand development and commericalisation agreement to include MK-6070

Daiichi Sankyo and Merck (known as MSD outside of the US and Canada) have announced the expansion of their co-development and co-commercialisation agreement – already investigating three dxd antibody drug conjugates (adcs) ‒ to include mk-6070.

5 September 2024Europe
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AbbVie acquires Cerevel Therapeutics

AbbVie has announced the acquisition of Cerevel Therapeutics, strengthening its neuroscience pipeline.

5 September 2024Europe
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Dive into the heart of pharma at CPHI Milan 2024

Join us at CPHI Milan 2024, the premier global event for pharmaceutical professionals, from 8-10 October at Fiera Milano, Milan, Italy. Celebrating 35 years of excellence, this event promises unparalleled opportunities for networking, innovation and professional growth. With over 62,000 attendees and 2,500 exhibitors, you’ll experience insightful seminars, cutting-edge exhibitions and new awards such as ‘Woman of the Year’ and ‘Future Leader’.

5 September 2024UK News
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Unmet needs in primary biliary cholangitis: Understanding challenges

How is primary biliary cholangitis (PBC) currently affecting patients; and, more importantly, what hopes does PBC Awareness Month bring for new treatment options?

5 September 2024Europe
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Eisai and Biogen’s Leqembi launched for AD in China

Eisai and Biogen have announced that Leqembi (lecanemab) has been launched in China as a treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia, following its approval in January 2024.

17 July 2024Global