March 27, 2022

CHMP recommends Opdivo + Yervoy for first line treatment of metastatic esophageal squamous cell carcinoma – BMS

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression greater than 1%. The European Commission (EC), which has […]

admin Health 0 46 sec read
March 25, 2022

Kerendia approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes – Bayer HealthCare

The European Commission has granted marketing authorization in the European Union (EU) for finerenone under the brand name Kerendia from Bayer HealthCare. Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. “Even when blood glucose […]

admin Health 0 1 min read
March 21, 2022

Positive early access decision by French Haute Autorité de Santé to use Idefirix as desensitization treatment for highly sensitized kidney transplant patients – Hansa Biopharma AB

Hansa Biopharma AB, the pioneer in enzyme technology for rare immunological conditions, announced that its first-in-class treatment Idefirix (imlifidase) has been granted early access post marketing authorization (Autorisation d’accès précoce) in France by French HAS (Haute Autorité de Santé) for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified […]

admin Health 0 2 min read
March 9, 2022

EU approves Ngenla in growth hormone deficient children – Pfizer + OPKO Health

Pfizer and OPKO Health announced that the European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone Ngenla (somatrogon), a once-weekly injection to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. Ngenla provides pediatric patients, their caregivers and healthcare providers with a new treatment option […]

admin Health 0 39 sec read
March 2, 2022

Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus – AstraZeneca

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. Saphnelo is the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of disease activity. […]

admin Health 0 1 min read
February 28, 2022

TGA in Australia has granted provisional registration for Spikevax COVID 19 vaccine for children aged 6-11 years old – Moderna

Moderna, Inc., announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 µg dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years. The TGA authorization for the use of the COVID-19 vaccine in children 6-11 years old […]

admin Health 0 32 sec read
February 27, 2022

NICE UK recommends Keytruda with carboplatin and paclitaxel for metastatic squamous non-small-cell lung cancer – Merck Inc

NICE (UK): Keytruda (pembrolizumab), from Merck Inc. with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, only if their tumours express PD?L1 with a tumour proportion score of 0% to 49%, if their tumours express PD?L1 with a tumour proportion score of 50% or more and they need urgent clinical […]

admin Health 0 1 min read
February 26, 2022

Sandoz launches generic lenalidomide in 19 countries across Europe

Sandoz has announced the launch of generic oncology medicine lenalidomide, indicated for several haemato-oncology conditions as recommended by the latest European Society for Medical Oncology (ESMO) guidelines. The medicine will become available to patients in 19 countries across Europe. The cost of treating multiple myeloma patients is high and continues to rise. Affordability of and access to new multiple myeloma […]

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February 14, 2022

Incyte announces FDA approval of Jakafi for treatment of chronic graft-versus-host disease

Incyte has announced that the FDA has approved Jakafi (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. “GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment […]

admin Health 0 1 min read
February 12, 2022

UK rolls out new drug approval pathway

Effective 1 January 2022 Pharmaceutical companies can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). The new approval pathway marks a collaboration by multiple UK government entities, including the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency (MHRA), the Scottish Medicines Consortium and the […]

admin Health 0 39 sec read

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