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Mar 14, 2024
On 14 March 2024, AstraZeneca announced that it has entered into an agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. Amoylt's portfolio notably includes eneboparatide...
Mar 13, 2024
On 13 March 2024, Sandoz reported double-digit growth of 15% in its 2023 biosimilar sales. Sandoz attributed this growth to the launch of Hyrimoz®(biosimilar to AbbVie’s Humira®,adalimumab) in the US and entering an agreement to commercialise Samsung Bioepis’ SB17...
Mar 12, 2024
On 12 March 2024, Regeneron filed notices of appeal in the United States Court of Appeals for the Federal Circuit challenging findings of the Patent Trial and Appeal Board (PTAB) that claims of two of its patents are invalid. The Regeneron patents at issue are...
Mar 11, 2024
The Biden Administration proposes to amend s352 of the Public Health Service Act so that all approved biosimilars are deemed to be interchangeable with their respective reference drug. On 11 March 2024, the Biden Administration released its 2025 Budget Proposal in...
Mar 11, 2024
Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval of CT-P39, as interchangeable biosimilar to Genentech’s Xolair® (omalizumab). Celltrion’s application seeks approval for all Xolair® indications, as...
Mar 11, 2024
On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s Lucentis®, was approved in Saudi Arabia for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases...
Mar 11, 2024
On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application (sBLA) for TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis. The product is currently approved in...
Mar 11, 2024
On 11 March 2024, MSD announced the completion of the acquisition of Harpoon Therapeutics for about USD $650M with the aim of augmenting and diversifying their oncology pipeline. Harpoon’s lead candidate is MK-6070 and its safety, tolerability and pharmacokinetics...
Mar 11, 2024
On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda (pembrolizumab) was approved in Korea as a 1st-line treatment for HER2-negative gastric cancer in combination with fluoropyrimidine and platinum-based...
Mar 11, 2024
On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children with genetic form of high cholesterol on 8 March 2024. The approval was based on Phase 3 randomized trials in patients aged 8-17. The results,...
Mar 10, 2024
On 10 March 2024, Eli Lilly announced results for its ADmirable lebrikizumab study. This is the first-of-its-kind study of lebrikizumab specifically designed to treat people with moderate-to-severe atopic dermatitis. This is also commonly known as eczema. The...
Mar 9, 2024
On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States. For its Humira® biosimilar...
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