July 19, 2023

MHRA (UK) approves Arexvy for prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older – GSK

GSK plc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorised […]

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July 18, 2023

Mulpleta approved in China to treatthrombocytopenia in adult patients with chronic liver disease – Eddingpharm

Shionogi announced that its Chinese license partner Eddingpharm has won regulatory approval for its thrombopoietin receptor agonist Mulpleta (lusutrombopag) in China. The drug was approved for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an elective invasive procedure. Originated by Shionogi, Mulpleta is a small molecule agonist of the human thrombopoietin […]

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July 17, 2023

Phase IIIb trial of fezolinetant shows positive topline results for treatment of vasomotor symptoms – due to menopause – Astellas

Astellas Pharma Inc. announced positive topline results from the Phase IIIb DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause . VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. The study, comprised of more than 450 women considered unsuitable […]

admin Health 0 1 min read
July 16, 2023

European Commission approves Opdivo + chemotherapy for neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1% – BMS

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1%. With this EC decision, Opdivo with chemotherapy becomes the first neoadjuvant immunotherapy-based treatment option approved […]

admin Health 0 2 min read
July 15, 2023

The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Luxturna for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations – Novartis

The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Novartis’ Luxturna (voretigene neparvovec) for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations. The company expects the gene therapy to be used in approximately 15 patients in Japan over five yearsIn the U.S., Luxturna was launched with a list price of $850,000, so Japan is anticipating […]

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July 14, 2023

MLHW (Japan) approves updated indication for Shingrix for the prevention of Shingles – GSK

GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved an updated indication for Shingrix (Recombinant Zoster Vaccine, Adjuvanted – RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over who are at increased risk of the condition. RZV, a non-live, recombinant sub-unit adjuvanted vaccine, was first approved in 2018 […]

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July 13, 2023

Imfinzi + Imjudo demonstrated sustained overall survival benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA phase III trial – AstraZeneca

Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at four years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment. These results from HIMALAYA will be presented at the 2023 European Society […]

admin Health 0 1 min read
July 12, 2023

Sandoz to launch Hyrimoz high-concentration formulation, marking Sandoz entrance into US immunology space

-Sandoz, a global leader in generic pharmaceuticals and biosimilars, announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection will be available in the United States starting July 1. Hyrimoz HCF (100 mg/mL) is approved to treat all indications no longer covered by the regulatory exclusivity for the reference medicine, Humira (adalimumab), as of July 1, 2023, […]

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July 11, 2023

Novartis divests “front of eye” ophthalmology assets to Bausch + Lomb

Novartis announced that it has signed an agreement to divest ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up to $2.5 billion, including $1.75 billion in upfront cash, plus additional milestone payments. The deal includes Xiidra, the first approved prescription treatment for the signs and symptoms of dry eye disease, […]

admin Health 0 26 sec read
July 10, 2023

FDA action for BLA for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis is now shifted to Q3 2023 – UCB

UCB, a global biopharmaceutical company,announced that the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis remains under review with the FDA. UCB previously communicated the FDA action was expected in Q2, 2023. UCB now anticipates the FDA action in Q3, 2023. There are no open Information Requests from the FDA regarding […]

admin Health 0 35 sec read

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