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 14 Dec 2024
Highlights from the 9-12 December 2024 CHMP meeting
13 December 2024 - The EMA’s CHMP recommended seventeen medicines for approval at its December 2024 meeting. ...
Posted by Michael Wonder on 14 Dec 2024
Roche’s Vabysmo pre-filled syringe approved in the EU for three retinal conditions that can cause blindness
13 December 2024 - Vabysmo PFS is the first and only pre-filled syringe containing a bi-specific antibody, offering a convenient alternative ...
Posted by Michael Wonder on 14 Dec 2024
FDA approves new treatment for congenital adrenal hyperplasia
13 December 2024 - Today, the US FDA approved Crenessity (crinecerfont) to be used together with glucocorticoids to control androgen levels ...
Posted by Michael Wonder on 14 Dec 2024
Novartis and the pan-Canadian Pharmaceutical Alliance achieve milestone agreement for Pluvicto
13 December 2024 - Targeted radioligand therapy closer to public reimbursement for eligible Canadian patients with PSMA positive metastatic castration ...
Posted by Michael Wonder on 14 Dec 2024
FDA accepts Ascendis Pharma’s supplemental biologics license application for TransCon hGH for the treatment of adults with growth hormone deficiency
12 December 2024 - PDUFA goal date is 27 July 2025. ...
Posted by Michael Wonder on 14 Dec 2024
Roche Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Tecentriq SC (atezolizumab solution for subcutaneous injection)
13 December 2024 - Roche Canada today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for Tecentriq ...
Posted by Michael Wonder on 14 Dec 2024
Deal struck to secure place of eczema drug on PBS
13 December 2024 - Health Minister Mark Butler has struck a deal to secure the place of a “life-changing” eczema ...
Posted by Michael Wonder on 13 Dec 2024
Tolebrutinib designated breakthrough therapy by the FDA for non-relapsing secondary progressive multiple sclerosis
13 December 2024 - Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple ...
Posted by Michael Wonder on 13 Dec 2024
FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma
13 December 2024 - Today, the FDA approved cosibelimab-ipdl (Unloxcyt, Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, for ...
Posted by Michael Wonder on 13 Dec 2024
Lilly's Omvoh (mirikizumab) recommended by CHMP for approval in the European Union for adults with moderately to severely active Crohn's disease
13 December 2024 - The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without ...
Posted by Michael Wonder on 13 Dec 2024
UK MHRA grants innovation passport designation to ILiAD Biotechnologies BPZE1 next generation intranasal pertussis vaccine
4 December 2024 - ILiAD Biotechnologies today announced that the UK MHRA has granted Innovation Passport designation to BPZE1, the leading ...
Posted by Michael Wonder on 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...
Posted by Michael Wonder on 13 Dec 2024
CDER establishes new Center for Real World Evidence Innovation
12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...
Posted by Michael Wonder on 13 Dec 2024
Stoke Therapeutics receives FDA breakthrough therapy designation for zorevunersen for the treatment of Dravet syndrome
4 December 2024 - Supported by evidence from clinical studies that indicate that zorevunersen may demonstrate substantial improvement over available therapies. ...
Posted by Michael Wonder on 13 Dec 2024
Phanes Therapeutics’ PT217 granted fast track designation by the FDA for NEPC
4 December 2024 - This is the second fast track designation granted to PT217 by the agency ...