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May 20, 2024
On 20 May 2024, Teva and Alvotech announced that their interchangeable high concentration citrate-free adalimumab biosimilar Simlandi® (adalimumab-ryvk, AVT02) is now available in the US. Simlandi® is indicated for rheumatoid arthritis, juvenile idiopathic arthritis,...
May 20, 2024
On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC). The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients...
May 20, 2024
On 20 May 2024, Regeneron and Sanofi announced the results of the NOTUS Phase 3 trial for use of Dupixent® (dupilumab) as a maintenance treatment in adults with uncontrolled COPD and type 2 inflammation. The results were published in the New England Journal of...
May 17, 2024
On 16 and 17 May 2024, respectively, the Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety approved MSD’s Keytruda® (pembrolizumab) for the following additional indications: locally advanced cervical cancer; and as an adjuvant after...
May 17, 2024
As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as...
May 17, 2024
On 17 May 2024, Regeneron filed a second complaint against Celltrion in the US District Court for the Northern District of West Virginia asserting infringement of 25 US patents relating to aflibercept (including method of treatment, formulation and manufacturing...
May 16, 2024
On 16 May 2024, the FDA granted accelerated approval to Amgen’s IMDELLTRATM (tarlatamab-dlle) for small cell lung cancer that has progressed on or after platinum-based chemotherapy. Tarlatamab is a Bispecific T-cell Engager (BiTE®) molecule designed to engage a...
May 15, 2024
On 15 May 2024, Formycon announced its partnership with MS Pharma in MENA for the commercialisation of its aflibercept biosimilar FYB203. Klinge Pharma GmbH, which holds the global commercialisation rights for Formycon’s FYB203, granted MS Pharma exclusive rights to...
May 14, 2024
During the first case management of this case in the Federal Court of Australia on 14 May 2024, it became clear that Cipla is challenging the patent term extension (PTE) on Novo Nordisk’s liraglutide formulation patent (AU 2004290862). The 9-month PTE was granted on 4...
May 13, 2024
On 13 May 2024, Regeneron and Sanofi announced that the FDA has accepted for priority review their supplemental biologics licence application (sBLA) for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). The target action date for...
May 13, 2024
On 13 May 2024, Outlook Therapeutics announced that it submitted a Marketing Authorisation Application (MAA) in the UK for its ophthalmic formulation of bevacizumab (ONS-5010, LYTENAVA™) for the treatment of wet AMD. Outlook Therapeutics is seeking to achieve FDA, EU...
May 13, 2024
On 13 May 2024, Boehringer Ingelheim (BI) announced a partnership with Cigna subsidiary Quallent Pharmaceuticals, under which Quallent will distribute high and low-concentration forms of BI’s citrate-free adalimumab biosimilar in the USA under its private label. BI...
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