Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2019
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 ...
Posted by Michael Wonder on 18 Sep 2019
NICE recommends Takhzyro
18 September 2019 - NICE - a health technology appraisal body in England and Wales - has recommended the use ...
Posted by Michael Wonder on 18 Sep 2019
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 ...
Posted by Michael Wonder on 18 Sep 2019
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 ...
Posted by Michael Wonder on 17 Sep 2019
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 ...
Posted by Michael Wonder on 16 Sep 2019
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 ...
Posted by Michael Wonder on 12 Sep 2019
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 ...
Posted by Michael Wonder on 12 Sep 2019
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 ...
Posted by Michael Wonder on 12 Sep 2019
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 ...
Posted by Michael Wonder on 12 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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, ...
Posted by Michael Wonder on 11 Sep 2019
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, ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 10 Sep 2019
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. ...