Author: Author

April 22, 2022 Off

Novo Nordisk’s NovoSeven Recommended for Approval for the Treatment of Severe Postpartum Haemorrhage by the EMA

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an extension of the Novo Nordisk’s NovoSeven (eptacog alfa) label to include treatment of women suffering from severe haemorrhage after giving birth, when medications used to induce uterine contractions and reduce bleeding (uterotonics) are insufficient to stop the bleeding.

April 22, 2022 Off

Novartis Receives Positive CHMP Opinion for Tabrecta for Patients with METex14 Advanced NSCLC

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Novartis’s Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

April 21, 2022 Off

AstraZeneca’s Evusheld Reduces the Risk of COVID-19 by 77%

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AstraZeneca has announced detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that  Evusheld (tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo.

April 20, 2022 Off

AbbVie’s Crohn’s Disease Drug to Treat Patients in UK

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The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for AbbVie’s risankizumab for treatment of adults and adolescents (16-17 years) with Crohn’s Disease (CD) who have had an inadequate response to, lost response to or were intolerant or contraindicated to tumour necrosis factor-alpha (TNFα) antagonist therapies, vedolizumab and ustekinumab.

April 20, 2022 Off

Moderna: Clinical update on bivalent COVID-19 booster platform

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Moderna has announced new clinical data on its bivalent COVID-19 booster platform including data on the company’s first bivalent booster candidate, mRNA-1273.211, which includes mutations found in the Beta variant of concern, several of which have been persistent in more recent variants of concern including Omicron.

April 20, 2022 Off

GSK’s Daprodustat Receives FDA Filing Acceptance

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The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for GlaxoSmithKline’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD).

April 15, 2022 Off

Nektar and BMS End Clinical Development of Bempegaldesleukin in Combination with Opdivo

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Nektar Therapeutics (NASDAQ: NKTR) and Bristol Myers Squibb (NYSE: BMY) have announced that based on results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in renal cell carcinoma (RCC) and bladder cancer, the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo.