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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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