Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2024
Blue Shield of California slashes cost of world's best selling drug
1 October 2024 - Non-profit health plan collaborates with Fresenius Kabi and Evio Pharmacy Solutions to purchase FDA approved Humira biosimilar ...
Posted by Michael Wonder on 05 Dec 2024
Canada’s Drug Agency launches consultation on methods guide
28 November 2024 - Canada’s Drug Agency is launching a consultation on its first ever methods guide. ...
Posted by Michael Wonder on 05 Dec 2024
MSAC publishes agenda for April 2025 MSAC meeting
27 November 2024 - - The MSAC Secretariat has published a list of applications scheduled to be considered by the ...
Posted by Michael Wonder on 05 Dec 2024
Orphelia Pharma provides update on the regulatory submission of Kizfizo with the EMA
18 November 2024 - Orphelia to seek re-examination following CHMP negative opinion for the treatment of relapsed or refractory high-risk ...
Posted by Michael Wonder on 05 Dec 2024
Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan approved for marketing by NMPA of China for second-line advanced or metastatic triple negative breast cancer
27 November 2024 - Sichuan Kelun-Biotech Biopharmaceutical announced that the Company received marketing authorisation in China from the NMPA for the ...
Posted by Michael Wonder on 05 Dec 2024
Results of health technology assessments of orphan drugs in Germany—lack of added benefit, evidence gaps, and persisting unmet medical needs
3 December 2024 - The number of orphan drug approvals has increased sharply in Europe. In Germany, all orphan drugs are ...
Posted by Michael Wonder on 05 Dec 2024
Health Canada approves Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction
27 November 2024 - Wegovy is the first and only medication indicated for both chronic weight management and to reduce the ...
Posted by Michael Wonder on 05 Dec 2024
Clearing dense drug patent thickets
27 November 2024 - Proposed reforms from the US Patent and Trademark Office and Congress could work in tandem to prevent ...
Posted by Michael Wonder on 05 Dec 2024
Applied Therapeutics receives complete response letter from US FDA regarding new drug application for govorestat for classic galactosaemia
27 November 2024 - Applied Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 05 Dec 2024
Lin BioScience receives US FDA fast track designation for LBS-007
27 November 2024 - A Phase 1/2 trial in patients with relapsed or resistant acute leukaemias is on-going. ...
Posted by Michael Wonder on 05 Dec 2024
Exelixis provides regulatory update related to supplemental new drug application for cabozantinib (Cabometyx) for the treatment of patients with previously treated advanced neuroendocrine tumors
26 November 2024 - 26, 2024-- Exelixis today announced that the US FDA has notified the company that the supplemental new ...
Posted by Michael Wonder on 05 Dec 2024
GSK’s fully liquid Menveo meningococcal vaccine approved by European Commission
27 November 2024 - New fully liquid presentation means reconstitution is not needed before use. ...
Posted by Michael Wonder on 05 Dec 2024
European Commission approves BeiGene’s Tevimbra for first-line treatment of advanced/metastatic oesophageal squamous cell carcinoma and gastric or gastro-oesophageal junction cancer
27 November 2024 - New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients ...
Posted by Michael Wonder on 04 Dec 2024
Fedratinib dihydrochloride monohydrate for the treatment of adults with disease-related splenomegaly or symptoms in myelofibrosis
20 November 2024 - NICE has published final evidence-based recommendations on the use of fedratinib dihydrochloride monohydrate (Inrebic) for the ...
Posted by Michael Wonder on 04 Dec 2024
Satsuma Pharmaceuticals and SNBL receive FDA acceptance of NDA resubmission of STS101 for the acute treatment of migraine with or without aura
26 November 2024 - Satsuma Pharmaceuticals and its corporate parent Shin Nippon Biomedical Laboratories are pleased to announce that the ...
Posted by Michael Wonder on 04 Dec 2024
Theratechnologies submits updated tesamorelin F8 formulation sBLA for FDA review
26 November 2024 - Resubmission addresses questions raised in January 2024 complete response letter. ...