Blog
RSS FeedPosted by Michael Wonder on 19 Jul 2024
Johnson & Johnson, BMS fight US drug price plan at Third Circuit
16 July 2024 - Pharmaceutical giants Johnson & Johnson, BMS and AstraZeneca are rejecting federal district court decisions that rule ...
Posted by Michael Wonder on 27 Jul 2024
Leo Pharma receives positive CHMP opinion of Anzupgo (delgocitinib cream) for the treatment of adults with moderate to severe chronic hand eczema
26 July 2024 - The positive opinion is based on results from the DELTA phase 3 program, which includes the randomised, ...
Posted by Michael Wonder on 27 Jul 2024
Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union
26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion ...
Posted by Michael Wonder on 27 Jul 2024
Ipsen receives CHMP positive opinions for Iqirvo (elafibranor) in primary biliary cholangitis and Kayfanda (odevixibat) in Alagille syndrome, two rare cholestatic liver diseases
26 July 2024 - Ipsen announced today two positive opinions by the EMA's CHMP for two different rare cholestatic liver disease ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for zolbetuximab in combination with chemotherapy for treatment of advanced gastric and gastro-oesophageal junction cancer
26 July 2024 - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2 targeted therapy approved ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 July 2024 - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination ...
Posted by Michael Wonder on 26 Jul 2024
Checkpoint Therapeutics announces FDA acceptance of BLA resubmission of cosibelimab for the treatment of advanced cutaneous squamous cell carcinoma
25 July 2024 - PDUFA goal date of 28 December 2024 set by FDA. ...
Posted by Michael Wonder on 26 Jul 2024
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of adults with moderately to severely active ulcerative colitis
26 July 2024 - The approval is supported by data from two pivotal Phase 3 trials: the INSPIRE induction trial and ...
Posted by Michael Wonder on 26 Jul 2024
Sandoz launches biosimilar Pyzchiva (ustekinumab) across Europe, to treat chronic inflammatory diseases
25 July 2024 - Pyzchiva first ustekinumab biosimilar to launch in Europe with all reference medicine strengths, including 130 mg vial ...
Posted by Michael Wonder on 26 Jul 2024
Mirum’s Livmarli now approved for PFIC in patients 12 months and older
25 July 2024 - Mirum Pharmaceuticals today announced that the US FDA has approved a label expansion for Livmarli (maralixibat) oral ...
Posted by Michael Wonder on 26 Jul 2024
Tonix Pharmaceuticals granted fast track designation by FDA for Tonmya for fibromyalgia
25 July 2024 - NDA submission on track for second half 2024. ...
Posted by Michael Wonder on 26 Jul 2024
AC Immune’s ACI-35.030 (now “JNJ-2056”) granted FDA fast track designation for Alzheimer’s aisease
25 July 2024 - Treatment of first randomised person with pre-clinical Alzheimer's disease expected this quarter. ...
Posted by Michael Wonder on 26 Jul 2024
EMA publishes agenda for 22-25 July 2024 CHMP meeting
22 July 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 26 Jul 2024
MHRA approves GLP-1 receptor agonist semaglutide to reduce risk of serious heart problems in obese or overweight adults
23 July 2024 - Semaglutide is the first weight loss drug approved in the UK as a preventative treatment for those ...
Posted by Michael Wonder on 26 Jul 2024
European Commission approves Pfizer’s Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with haemophilia B
25 July 2024 - A one-time dose of Durveqtix has reduced bleeds post-treatment compared to standard of care with a median ...