The US Food and Drug Administration (FDA) has approved Galderma’s Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. 14 August 2024
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.
Privately-held Danish dermatology specialist LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and earnings before interest, tax, depreciation and amortization for 2023. 1 March 2024
USA-based Pelage Pharmaceuticals, a clinical-stage regenerative medicine company developing treatments for hair loss, has closed a $16.75 million Series A financing. 27 February 2024
Icelandic firm Alvotech and Israel’s Teva Pharmaceutical Industries on Friday announced that the US Food and Drug Administration (FDA) has approved Simlandi (adalimumab-ryvk) injection. 26 February 2024
Last week saw UK pharma major AstraZeneca announce that the US Food and Drug Administration (FDA) has accept its biological license application (BLA) for datopotamab deruxtecan for the treatment of lung cancer and also release positive Phase III results for Tagrisso in lung cancer. The FDA also granted approval for US biotech Iovance’s Amtagvi as a treatment for advanced melanoma, and slapped a clinical trial hold on US drug developer RAPT Therapeutics’ study of zelnecirnon in atopic dermatitis. Also of note, Rigel Pharmaceuticals entered into a deal to acquire US rights to cancer drug Gavreto that were recently handed back to Blueprint Medicines by Swiss pharma giant Roche. 25 February 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its February 2024 meeting. 23 February 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance which recommends US pharma giant Pfizer’s Litfulo (ritlecitinib). 22 February 2024
South Korean biosimilars company Samsung Bioepis today announced that two new study results for SB17, a proposed biosimilar to Stelara (ustekinumab), marketed by Johnson & Johnson, will be presented at the 19th Congress of European Crohn’s and Colitis Organization (ECCO) being held from February 21 to 24 in Stockholm, Sweden. 22 February 2024
RAPT Therapeutics revealed that the US Food and Drug Administration (FDA) has verbally notified the company that a clinical hold has been placed on the company’s Phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and its Phase IIa trial in asthma. 20 February 2024
Spain’s Almirall has entered into an exclusive license agreement with Novo Nordisk for rights to the IL-21 blocking monoclonal antibody, NN-8828. 19 February 2024
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024