Category: Europe

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

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

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

Valneva’s Inactivated Covid-19 Vaccine Gets CMA in UK
April 14, 2022 Off

Valneva’s Inactivated Covid-19 Vaccine Gets CMA in UK

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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for primary immunization in adults 18 to 50 years of age.

EMA and the EUnetHTA 21 consortium set priorities for their collaboration
April 13, 2022 Off

EMA and the EUnetHTA 21 consortium set priorities for their collaboration

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The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a  joint work plan until 2023. The focus of the plan is to prepare, from a methodological and operational perspective, for the coming into application of the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025 after a 3-year implementation period.

GSK Buys Sierra Oncology for $1.9bn
April 13, 2022 Off

GSK Buys Sierra Oncology for $1.9bn

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GlaxoSmithKline plc (LSE/NYSE: GSK) and Sierra Oncology, Inc (Nasdaq: SRRA) have entered into an agreement under which GSK will acquire Sierra Oncology, a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion (£1.5 billion).