First biosimilar of dornase alfa inhalation solution for CF approved in Russia, companies announce

19 September 2019 - A biosimilar of dornase alfa inhalation solution, with the same therapeutic activity as Pulmozyme, its reference ...

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NICE recommends Takhzyro

18 September 2019 - NICE - a health technology appraisal body in England and Wales - has recommended the use ...

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Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes

12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...

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U.S. FDA approves supplemental new drug application for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer

17 September 2019 - Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of ...

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Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma

18 September 2019 - The Therapeutic Goods Administration has provisionally approved the use of lenvatinib (Lenvima) in combination with pembrolizumab ...

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Lenvima to get benefit as first-line treatment of hepatocellular carcinoma

16 September 2019 - Lenvima (lenvatinib), a new liver cancer drug that arrived in a decade after Nexavar (sorafenib), is to ...

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Ardelyx receives FDA approval for Ibsrela (tenapanor), an NHE3 sodium transport inhibitor, for the treatment of irritable bowel syndrome with constipation

12 September 2019 - Approval supported by two Phase 3 trials demonstrating a statistically significant reduction in constipation and abdominal pain ...

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Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma

12 September 2019 - GlaxoSmithKline today announced that the US FDA has approved Nucala (mepolizumab) for use in children as young ...

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Aspen's drug to prevent preterm birth approved by FDA

13 September 2019 - The U.S. Food and Drug Administration (FDA) has approved Aspen Pharmacare’s hydroxyprogesterone caproate, which is used to ...

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SMC U-turn for Vertex’s CF drugs

12 September 2019 - Vertex has announced that following a change of heart by the SMC, eligible cystic fibrosis patients ...

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NICE publishes its 600th technology appraisal guidance

12 September 2019 - The guidance relates to the use of pembrolizumab in combination with carboplatin and paclitaxel on the ...

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The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018

10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...

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Canada OKs Celltrion's biosimilar

10 September 2019 - Celltrion said that Health Canada has given the go-ahead for Herzuma (trastuzumab), an anticancer antibody biosimilar, ...

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Decision for funding in the immunosuppressant, cardiovascular and anti-nausea therapeutic areas

11 September 2019 - PHARMAC pleased to announce a decision to approve proposals relating to medicines in the immunosuppressant, cardiovascular ...

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Xeris Pharmaceuticals receives U.S. FDA approval for Gvoke (glucagon), the first ready-to-use stable liquid glucagon for severe hypoglycaemia

10 September 2019 - First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies. ...

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