Earlier this September, the US Food and Drug Administration (FDA) granted approval for PureTech Health’s Karxt for the treatment of schizophrenia in adults, triggering royalty payments of $29m to PureTech. It will be the first approved mechanism by the FDAfor schizophrenia in over 50 years.

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Owlstone Medical has entered into a research collaboration with the US Food and Drug administration’s (FDA) centre for devices and radiological health to develop methods for the confident identification of individual chemicals in the composure of breath.

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Welcome to the October issue of Pharmafocus!

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Finnish pharmaceutical company Orion has announced that its partner Bayer is applying for a third application of its prostate cancer drug, darolutamide, in the US.

Santhera Pharma has announced the results of its LIONHEART study, which evaluated Vamorolone – a corticosteroid – and confirmed its action as a mineralcorticoid receptor antagonist (MRA).

Recipharm and Exela have announced that they have entered into an exclusive strategic alliance. The alliance between the two contract development and manufacturing organisations (CDMOs) aims to enhance sterile manufacturing capabilities in the US. As part of the alliance, Recipharm will be able to take advantage of Exela’s state-of-the-art manufacturing plant in Lenoir, NC, US.

Risk-based quality management (RBQM) and data quality oversight software company Cluepoints launches its latest application, the medical & safety review (MSR), to simplify and streamline the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history.

Headlands Research, a multinational network of clinical research sites, has launched a new clinical trials site in El Paso, Texas, US.

Johnson & Johnson Innovative Medicine (formerly Janssen) has announced the long-term phase 3 results from its cartitude-4 study, which evaluated treatment CARVYTKI in patients with relapsed or lenalidomiderefractory multiple myeloma after one prior line of therapy.

Tiziana Life Sciences, a biotechnology company developing immunomodulation therapies, announced that the National Institutes of Health (NIH),'s National Institute on Aging has awarded a $4m grant to Dr Howard Weiner as principal investigator at Brigham and Women’s Hospital to be the key research site to study nasal anti-cd3 for the treatment of alzheimer’s disease (ad).

The US Food and Drug Administration has approved Sanofi’s Dupixent as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

The European Commission (EC) has approved Astellas Pharma’s vyloy (zolbetuximab) in combination with fluoropyrimidine and platinum-containing chemotherapy as a treatment for adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.

Etranacogene dezaparvovec (hemgenix), the first gene therapy approved in Europe for the treatment of severe and moderately severe haemophilia B in adult patients, has been approved for national reimbursement by the Spanish Interministerial Pricing Commission for Pharmaceuticals (CIPM).

The Ministry of Health, Labour and Welfare Japan has approved treatment for Eli Lilly’s KINSULA, indicated for adult patients with early symptomatic Alzheimer’s disease (AD). This also includes patients with mild dementia stage AD, and mild cognitive impairment.

The European Microbiome Innovation for Health (EMIH) association and the Microbiome Therapeutics Innovation Group (MTIG) have announced a new collaborative agreement. The agreement seeks to advance microbiome drug development by improving collaboration between the two microbiome focused coalitions.

Liquid biopsy company ANGLE plc has announced a partnership with NuProbe, a genomics and molecular diagnostics company, to utilise the latter’s pan-cancer next-generation sequencing (NGS) panel.

Clinical stage biotechnology company PolTREG has launched a study with CAR-Treg cells in a humanised mouse model of neuroinflammatory disease. If preclinical testing is a success, first-in-human trials for multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) are expected in 2025.

Oxford Drug Design has been awarded a portion of a £3m drug discovery programme fund organised by the cystic fibrosis antimicrobial resistance (CF AMR) syndicate. The collaborative discovery programme (CDP) has been set up to support six early-stage novel antimicrobial projects with the aim of accelerating new treatments for people with CF suffering from lung infections, and is funded in full by LifeArc – a self-funded, not-for-profit medical research charity.

A number of advocacy groups, including the anti-monopoly American Economic Liberties Project (AELP), have written to the US Federal Trade Commission (FTC) asking it to block recent oncology-focused acquisitions.

Genentech, part of the Roche Group, has entered into a definitive purchase agreement with Regor Pharmaceuticals (US) for its portfolio of next-generation cyclin-dependent kinase (CDK) inhibitors, which have shown promise in the treatment of breast cancer.

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Martin Cowie at AstraZeneca elaborates on the urgent need for faster diagnoses in the field of heart failure.

As the life sciences become increasingly aware of a lack in diversity, how can we improve this in genomics research?

How are corneal transplants advancing in the field of ophthalmology?

Aseptic packaging company Steriline’s founder Gerardo Fumagalli has ‘passed the torch’ to his children Illaria Fumagalli and Federico Fumagalli, who have been appointed to chief executive officer and chief sales officer, respectively. Gerardo will continue on as chairman of the board of directors.

Prilenia, a clinical stage biotech focusing on neurodegenerative and neurodevelopmental disorders, has announced the appointment of two new senior staff members ‒ Rob Lauzen as chief financial officer (CFO) and Jason Marks as chief legal officer (CLO).

Pharmaceutical company Eli Lilly has announced the appointment of two senior positions in its public affairs and communications team.

SFA Therapeutics, a clinical-stage biopharmaceutical company, has announced that it has appointed Dr Anada Gubbi as director of biostatistics. Dr Gubbi will be responsible for assisting SFA Therapeutics in effectively developing drug candidates for the treatment of inflammatory diseases.

1. Despite raised awareness around diversity, equity and inclusion (DEI) in the pharma sector, there are still issues surrounding the implementation of DEI in research.

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