The FDA has announced that it has approved Rezdiffra (resmetirom) for the treatment of adult patients with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver scarring (fibrosis), for use alongside diet and exercise.

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Gilead sciences and Merck (known as MSD outside of the US and Canada) have announced results from the phase 2 clinical study assessing the combination of islatravir and lenacapavir for viral suppression in HIV treatment.

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Welcome to the April 2024 issue of Pharmafocus!

Considering the landscape of women’s health in 2024

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Roche has shared the latest data on its novel solution for continuous glucose monitoring (CGM), including a CGM sensor and two apps designed to present current glucose values and predictions over 30 minutes and two hours.

AstraZeneca has announced that the European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (dato-dxd) in the treatment of two cancers.

Spero Therapeutics has announced that it has gained FDA clearance for the investigational new drug (IND) application to assess SPR206 in a phase 2 clinical study.

Amneal Pharmaceuticals has announced that it has entered into an exclusive licensing agreement with Zambon Biotech for IPX204 in the EU, UK and Switzerland.

GSK has announced positive results from part 1 and part 2 of its ruby/engot-en6/gog3031/ nsgo phase 3 trial for Jemperli (dostarlimab) in combinations for the treatment of adult patients with primary advanced or recurrent endometrial cancer.

Merck, known as MSD outside of the US and Canada, has announced positive results from the phase 3 KEYNOTE-a18 trial, which investigates Keytruda in combination with chemoradiotherapy for the treatment of newly diagnosed patients with high-risk locally advanced cervical cancer.

Sanofi has shared positive results from part 2 of the investigational phase 2b STREAM-AD study of Amlitelimab for adult patients with moderate-to-severe atopic dermatitis (ad) who previously responded to Amlitelimab and continued treatment.

Sosei Heptares has announced that it has dosed the first patient in its phase 1 trial assessing a novel ep4 receptor agonist, HTL0033744 (htl’744) for the treatment of inflammatory bowel disease (IBD).

Niea.pharmatimes.com

AstraZeneca has announced that the FDA has approved Ultomiris (ravulizumab-cwvs) as the first and only long-acting c5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (aqp4) antibody-positive (ab+) neuromyelitis optica spectrum disorder (nmosd).

Johnson & Johnson (J&J) has announced that the FDA has approved Opsynvi (macitentan and tadalafil) for the chronic treatment of adults with pulmonary arterial hypertension (PAH).

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Awiqli (once-daily basal insulin icodec) for the treatment of diabetes in adult patients.

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Hyqvia as a maintenance therapy for patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) following stabilisation with an intravenous immunoglobin therapy (IVIG).

Msea.pharmatimes.com

Johnson & Johnson (J&J) MedTech has announced that it is working in collaboration with NVIDIA to accelerate and scale artificial intelligence (AI) for use in surgeries.

Bayer and AIgnostics have announced that they have entered into a strategic collaboration for several artificial intelligence (AI)-powered approaches for precision oncology drug research and development.

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Merck, known as MSD outside of the US and Canada, has announced that it is planning to initiate clinical development of a new investigational multivalent human papillomavirus (HPV) vaccine, as well as assessing a single-dose regimen of Gardasil 9 compared to its approved three-dose regimen.

Allumiqs and Prolytix have announced that they have entered into a long-term, strategic partnership with the aim of providing collaborative and integrated solutions for their customers to optimise drug development pipelines.

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AstraZeneca has announced that it has entered into a definitive agreement to acquire Fusion Pharmaceuticals for an approximate $2bn.

Merck, known as MSD outside of the US and Canada, has announced that it has completed the acquisition of Harpoon Therapeutics, meaning it is now a wholly owned subsidiary of Merck.

Johnson & Johnson has announced that it has successfully completed its acquisition of Ambrx Biopharma in an all-cash merger transaction with a total equity value of approximately $2bn.

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Sebastien Noel from Veeva Systems considers the potential benefits and drawbacks of messaging services for HCPs as well as explaining Veeva’s own platform, which combats these issues

Alex Devereson and Delphine Zurkiya from McKinsey consider the value of generative AI in the pharma industry

Dr Charlotte Owens from Organon explores the impact of innovations in contraception and how this can reduce unintended pregnancy rates

Frances Ramsay from InnoScot Health discusses the way forward in closing the gender health gap

Betsy Goodfellow from Pharmafocus considers the current landscape of women’s health, covering recent debates and ongoing issues within the reproductive health sphere

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BenevolentAI has announced that Dr Daniel Neil, current chief technology officer (CTO) is stepping down, to be succeeded by Dr James Malone, who joins the company in April.

Nuclera has announced that it has appointed Joseph Bertelsen as chief commercial officer (CCO).

Parexel has announced that its CEO, Jamie MacDonald will retire, with the company’s current chief operating and growth officer Peyton Howell taking over as CEO, effective 15 May 2024.

Vynamic has announced the appointment of Gemma Pfister as head of life sciences Europe.

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