Blog
RSS FeedPosted by Michael Wonder on 17 May 2024
HLB shares plummet following FDA rejection of liver cancer drug approval
17 May 2024 - HLB revealed that its US subsidiary, Elevar Therapeutics, and their Chinese partner, Jiangsu Hengrui Pharmaceuticals, received ...
Posted by Michael Wonder on 17 May 2024
Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test
14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...
Posted by Michael Wonder on 16 May 2024
Tisagenlecleucel for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukaemia
15 May 2024 - NICE has published final evidence-based recommendations on the use of tisagenlecleucel (Kymriah) for the treatment of ...
Posted by Michael Wonder on 16 May 2024
Selinexor in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (final guidance)
15 May 2024 - NICE has published final evidence-based recommendations on the use of selinexor (Nexpovio) in combination with bortezomib ...
Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
Posted by Michael Wonder on 15 May 2024
Atogepant monohydrate for the prevention of migraine
15 May 2024 - NICE has published final evidence-based recommendations on atogepant monohydrate (Aquipta) for preventing migraine in adults. ...
Posted by Michael Wonder on 15 May 2024
ViiV Healthcare announces Health Canada approval for Apretude (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV
13 May 2024 - The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a ...
Posted by Michael Wonder on 14 May 2024
Baxter secures FDA approval of Clinolipid (lipid injectable emulsion) neonatal and paediatric indication
13 May 2024 - Expanded indication demonstrates Baxter’s continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates ...
Posted by Michael Wonder on 14 May 2024
Institute for Clinical and Economic Review publishes evidence report on treatment for post-traumatic stress disorder
14 May 2024 - There are substantial uncertainties around the clinical trial results; given the inability to assess net benefit, ...
Posted by Michael Wonder on 14 May 2024
FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...
Posted by Michael Wonder on 14 May 2024
SMC - May 2024 decisions
13 May 2024 - The SMC has today published advice on two medicines. ...
Posted by Michael Wonder on 13 May 2024
Zai Lab announces approval of Augtyro (repotrectinib) for patients with ROS1 positive NSCLC by China’s NMPA
12 May 2024 - The approval is based on the pivotal TRIDENT-1 trial, in which Augtyro achieved a high response ...
Posted by Michael Wonder on 13 May 2024
Remdesivir and the combination of tixagevimab and cilgavimab for the treatment of patients with COVID-19 disease (final guidance)
8 May 2024 - NICE has published final evidence-based recommendations on the use of remdesivir (Veklury) and tixagevimab and cilgavimab ...
Posted by Michael Wonder on 11 May 2024
Health Canada approves Keytruda for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy
9 May 2024 - Approval is based on the Phase 3 KEYNOTE-966 Trial. ...
Posted by Michael Wonder on 10 May 2024
Qulipta (atogepant) now approved by Health Canada for the preventive treatment of chronic migraine in adults
8 May 2024 - Approval was based on a pivotal Phase 3 clinical trial that demonstrated statistically significant reduction from baseline ...