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 […]

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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 […]

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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 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 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
July 9, 2023

MAA submitted to the European Medicines Agency for approval of single tablet combination therapy of macitentan and tadalafil for treatment of pulmonary arterial hypertension – Jansen Pharmaceuticals

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of a single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of […]

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July 8, 2023

Complete Response Letter for AVT 02 biosimilar candidate for Humira – Alvotech

Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT 02, a high-concentration biosimilar candidate for Humira (adalimumab). As the second of two BLAs submitted for AVT 02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation. The CRL […]

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July 7, 2023

CHMP positive for Jesduvroq to treat symptomatic anemia in adults with chronic kidney disease who are on dialysis – GSK

Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic kidney disease who are on chronic dialysis. The benefit of Jesduvroq is its ability to correct haemoglobin levels in dialysis-dependent patients, with effects comparable to those seen with erythropoiesis-stimulating agents. The most […]

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July 6, 2023

Late-breaking efanesoctocog alfa data presented at ISTH demonstrates highly effective bleed protection in children with severe haemophilia A with once-weekly dosing – SOBI + Sanofi

Pivotal data from the Phase III XTEND-Kids study evaluating efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis in previously treated patients younger than 12 years of age with severe haemophilia A were presented in a late-breaking session at the Annual Meeting of the International Society on Thrombosis and Haemostasis (ISTH) in Montreal, Canada. The oral presentation detailed results […]

admin Health 0 2 min read

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