Janssen Pharmaceuticals, a Johnson & Johnson company, has announced a development and commercialisation agreement with Sanofi for Janssen’s extraintestinal pathogenic escherichia coli investigational vaccine programme.

PMEA

India-based pharma company Sun Pharmaceutical Industries has announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for deuruxolitinib for the treatment of adults with moderate-to-severe alopecia areata.

Samedan

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Considering health inequalities and digital therapeutics

Pharmafocus

Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has accepted their supplemental biologics license application for Dupixent (dupilumab) for the treatment of children between one and 11 years old with eosinophilic oesophagitis (EOE).

Karuna Therapeutics has announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Karxt (xanomeline-trospium) for the treatment of schizophrenia.

US-based clinical stage biopharmaceutical company Avalyn Pharma has announced that it has raised $175m in series c financing to continue its portfolio of inhalation therapies.

Acesion Pharma has announced that it has closed an oversubscribed €45m series b financing round.

Genentech has announced positive topline long-term results from its global phase 3 BALATON and COMINO trials, which assessed extended treatment intervals with Vabysmo (faricimab-svoa) in macular oedema due to branch and central retinal vein occlusion (BRVO and CRVO).

Sanofi has shared new data for the long-term efficacy of Nexviazyme (avalglucosidease alfa) for the treatment of Pompe disease at the 28th annual congress of the world muscle society (WMS) in Charleston, South Carolina, US.

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Moderna has announced positive interim results from the phase 1/2 trial of mRNA-1083, its investigational combination vaccine against influenza and COVID-19.

AstraZeneca and Daiichi Sankyo have shared positive high-level results from the tropion-breast01 phase 3 trial, which showed datopotamab deruxtecan (dato-dxd) demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (pfs) compared to chemotherapy in patients with inoperable or metastatic hormone receptor (hr)-positive, her2-low or negative breast cancer.

Biogen has announced that the FDA has approved Tofidence (tocilizumab-bavi) as an intravenous formulation, a biosimilar monoclonal antibody referencing actemra.

The World Health Organization (WHO) has announced that it has recommended a new vaccine, r21/matrix-m, for the prevention of malaria in children.

Pfizer has announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended abrysvo, the company’s bivalent respiratory syncytial virus (RSV) vaccine, for maternal immunisation.

Eli Lilly and Boehringer Ingelheim have announced that the FDA has approved Jardiance (empagliflozin) 10mg tablets to reduce risk of sustained decline in estimated glomerular filtration rate (EGFR), end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease (CKD).

GSK has announced that it has come to an exclusive agreement with Chingqing Zhifei biological products to co-promote GSK’s shingles vaccine, Shingrix, in China for an initial three years, with the option to extend the partnership further.

Sanofi and Teva Pharmaceuticals have announced that they will collaborate for the co-development and co-commercialisation of TEV’574, a treatment for ulcerative colitis (UC) and crohn’s disease, currently in phase 2b clinical trials.

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The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the invitae common hereditary cancers panel, which is an in vitro diagnostic test to detect hundreds of genetic variations associated with risk of developing certain cancers.

The University of Birmingham, UK hosted bacterial vaccines network has been awarded £1.4m in funding from the UK government to accelerate the development of bacterial vaccines in the fight against antimicrobial resistance (AMR).

Bristol Myers Squibb (BMS) and Mirati Therapeutics have announced that they have entered into a definitive agreement under which BMS will acquire Mirati for $58 per share, or a total value of $4.8bn.

Eli Lilly and POINT Biopharma have announced a definitive agreement for Lilly to acquire POINT to expand its pipeline of clinical and preclinical-stage radioligand therapies for the treatment of cancer.

Alfasigma and Intercept Pharmaceuticals have announced that they have entered into a definitive merger agreement, meaning Alfasigma will acquire Intercept for $19 per share.

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Louisa Steinberg and Maureen Glynn from ICON consider the role of digital therapeutics in the treatment of central nervous system conditions and how they can be used to improve clinical trials

Betsy Goodfellow from Pharmafocus reviews Gilead’s innovative new book, From the Margins. Described as ‘the most difficult book to read’, it highlights stories of hardship, stigmatisation, abuse and marginalisation

Pharmarole.com

Closed Loop Medicine has announced the appointment of Konstantinos Vlassis as chief technology officer.

CEO and president of FUJIFILM Diosynth Biotechnologies Lars Petersen has appointed Maja Pedersen as chief quality officer, where she will serve as a member of the executive leadership team.

Invisius Limited has announced that it has appointed Professor Bernard Canaud to its clinical advisory board.

Pheon Therapeutics has announced hat it has appointed Arvin Yang MD PhD as chief medical officer.

Read on for five key facts about health inequalities

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