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.

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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).

Pharmarole.com

Page 14 – precision medicine and the role of pathologists in multidisciplinary bladder cancer care

Welcome to the september issue of pharmafocus!

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Leading life science investor novo holdings has announced a £50m investment in oxford nanopore technologies. Oxford nanopore technologies is a leading uk-listed company currently specialising in a new generation of molecular sensing technology based on nanopores.

Drug discovery company Cresset has announced the extension of its global collaboration with chemical and biological contract research organisation (cro) Enamine.

Accord healthcare have recently announced that NICE have recommended the first oral androgen deprivation therapy (adt) treatment for hormone-sensitive prostate cancer. Prostate cancer is the most common cancer in men across the uk.

This month, Verisense have announced that their digital biobank, with data from over one million people, is open for business.

Biotechnology company Levicept has announced positive results from its phase 2 trial into levi-04 for the treatment of osteoarthritis.

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.

Calliditas therapeutics ab has recently announced that the phase 2b transform trial met its primary endpoint. The trial showed statistically significant improvement in alkaline phosphatase (alp) for both doses tested versus placebo. the trial evaluated setanaxib, a nox enzyme inhibitor, in patients with primary biliary cholangitis (pbc) and elevated liver stiffness.

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)

The National Institute for Health and Care excellence (NICE) have recommended adult patients in England or Wales with moderately or severely active ulcerative colitis (uc) who have not responded well to or cannot tolerate conventional or biological therapy including a tumour necrosis factor (tnf) alpha inhibitor the option of skyrizi (risankizumab).

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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.

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).

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).

Eisai and Econavista have announced that they have entered into a business alliance agreement, initiating their collaboration intended to build an ecosystem in the field of dementia.

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.

Memorial Sloan Kettering (MSK) have paired with Absci corporation to develop and discover new novel therapeutics through the use of generative artificial intelligence (genAI).

Merck (known as MSD outside the US and Canada) have announced that they have entered into an agreement with private biotechnology company Curon Biopharmaceuticals to acquire cn201, a novel investigational clinical-stage bispecific antibody for the treatment of b-cell associated diseases.

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

Interphex.com

How can the combined power of multidisciplinary teams and precision medicine be harnessed for people living with bladder cancer?

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’.

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

Oral peptides are becoming an attractive drug candidate due to their efficacy and potency. How are parenteral drug products impacting the distribution of this new candidate?

Earlier this month, seaport therapeutics appointed david wheadon md to their board of directors.

Liz romano has been promoted to the new position of director of communications and participant engagement by richmond pharmacology. The position has been created to support richmond’s strategic ambitions and communications and its commitment to enhancing engagement with participants in its clinical trials.

Elrig.org

1. Primarily biliary cholangitis (pbc) is an autoimmune disease that damages the bile ducts, leading to their degradation and destruction. Historically, it has also be referred to as primary biliary cirrhosis.1