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 13 Dec 2024
Allay Therapeutics receives FDA breakthrough therapy designation for ATX101 for the treatment of post-surgical pain following total knee replacement surgery
4 December 2024 - Breakthrough therapy designation supported by results from a Phase 2 dose-ranging trial. ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 12 Dec 2024
Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced oesophageal squamous cell cancer
11 December 2024 - NICE is unable to make a recommendation on the use in the NHS of toripalimab (Loqtorzi) in ...
Posted by Michael Wonder on 12 Dec 2024
Merck's Tepmetko, GSK-Janssen's Vocabria+Rekambys combo move closer to reimbursement in Korea
6 December 2024 - Merck's MET inhibitor Tepmetko (tepotinib) has been recognized by the national health insurance reviewer as eligible ...
Posted by Michael Wonder on 12 Dec 2024
Immuneering granted FDA fast track designation for IMM-1-104 in advanced melanoma
12 December 2024 - MM-1-104 was observed to be uniquely well tolerated in Phase 1 data shared at ESMO 2024, relative ...
Posted by Michael Wonder on 12 Dec 2024
Two combination vaccine candidates for prevention of influenza and COVID-19 granted fast track designation in the US
11 December 2024 - Two Phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by ...
Posted by Michael Wonder on 12 Dec 2024
ICER announces most significant drug price hikes unsupported by new clinical evidence in US
12 December 2024 - Of 10 high expenditure drugs that had substantial 2023 net price increases, five were not supported ...
Posted by Michael Wonder on 12 Dec 2024
EpicentRx's oncolytic virus-delivered TGFβ Inhibitor, AdAPT-001, receives FDA fast track designation for recurrent or refractory soft tissue sarcoma treatment
5 December 2024 - EpicentRx announced today that the US FDA granted fast track designation for the oncolytic adenovirus-delivered transforming growth ...
Posted by Michael Wonder on 12 Dec 2024
FDA grants Revescor (rexlemestrocel-L) regenerative medicine advanced therapy designation in children with congenital heart disease
5 December 2024 - Earlier this year FDA granted Revascor both rare paediatric disease designation and orphan drug designation for ...
Posted by Michael Wonder on 12 Dec 2024
Intra-Cellular Therapies submits supplemental new drug application to FDA for Caplyta (lumateperone) for the treatment of major depressive disorder as adjunctive therapy
3 December 2024 - The sNDA submission is based on positive results from Studies 501 and 502 demonstrating Caplyta’s robust anti-depressant ...
Posted by Michael Wonder on 12 Dec 2024
Outcome statements for October 2024 stakeholder meetings: oral contraceptives and migraine
9 December 2024 - The Outcome Statements are now available for the Oral Contraceptives Stakeholder Meeting held on 10 October 2024 ...
Posted by Michael Wonder on 12 Dec 2024
Elranatamab for treating relapsed and refractory multiple myeloma after three or more treatments (final guidance)
11 December 2024 - NICE has published final evidence-based recommendations on the use of elranatamab (Elrexfio) for the treatment of ...
Posted by Michael Wonder on 11 Dec 2024
Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada
9 December 2024 - Omlyclo (CT-P39) is the first and only omalizumab biosimilar referencing Xolair approved in Canada to treat multiple ...
Posted by Michael Wonder on 11 Dec 2024
Theratechnologies receives March 2025 PDUFA goal date for updated tesamorelin F8 formulation sBLA
10 December 2024 - Theratechnologies today announced that the US FDA has assigned a PDUFA goal date of 25 March ...
Posted by Michael Wonder on 11 Dec 2024
Delgocitinib approved to treat adult patients with moderate to severe chronic hand eczema
10 December 2024 - The MHRA has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand eczema in ...