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Biotechnology
Italian drugmaker Philogen has announced its decision to voluntarily withdraw the application for marketing authorization to the European Medicines Agency (EMA) for Nidlegy(daromun), a biological investigational medicinal product which is intended to be used for the neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma. 27 June 2025
Biotechnology
US biotech Nektar Therapeutics experienced a remarkable 130% increase in its share price, which reached $21.9, as it reported the successful outcome of a study related to atopic dermatitis. 24 June 2025
Biotechnology
New York-based Formation Bio, an AI-native pharma company focused on accelerating drug development, revealed that its subsidiary Libertas Bio has licensed gusacitinib to Sanofi, expanding the partnership between the companies. 24 June 2025
Biotechnology
Further expanding the indications for French pharma major Sanofi’s mega-blockbuster Dupixent (dupilumab), the US Food and Drug Administration (FDA) has approved the drug for the treatment of adult patients with bullous pemphigoid (BP). 20 June 2025
Biotechnology
Spanish skincare specialist Almirall has promised a key contribution at the International Congress of Dermatology (ICD), currently taking place in Rome, Italy. 19 June 2025
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has today recommended Spevigo (spesolimab) for the treatment of generalized pustular psoriasis (GPP) flares in adults in England and Wales. 18 June 2025
Biotechnology
Californian biotech Jasper Therapeutics presented data from the 180mg cohort of the company’s SPOTLIGHT Phase Ib/IIa study of subcutaneous briquilimab in adult participants with chronic inducible urticaria (CIndU) at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress. 16 June 2025
Biotechnology
US immunology specialist Celldex was trading 5% higher midday Friday, following on from 10% gains on Thursday. 13 June 2025
Biosimilars
South Korea’s biosimilar drug developer Samsung Bioepis has announced that the company has entered into a license, development and commercialization agreement with Nipro Corporation for multiple biosimilar candidates including SB17, a ustekinumab biosimilar candidate, in Japan. 9 June 2025
Biotechnology
Swiss skincare specialist Galderma has announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio (nemolizumab) in moderate-to-severe atopic dermatitis (AD). 9 June 2025
Biotechnology
US biotech Regeneron Pharmaceuticals and French pharma major Sanofi on Saturday presented results from the DISCOVER Phase IV, single-arm, open-label trial assessing Dupixent (dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis with skin of color. 9 June 2025
Pharmaceutical
The atopic dermatitis market across the seven major markets is forecast to nearly triple in value over the next decade, driven by advances in targeted therapies and a deeper understanding of disease mechanisms. 5 June 2025
Pharmaceutical
Danish dermatology specialist LEO Pharma has appointed Helle Hedegaard Juhl as executive vice president for global people and corporate affairs (GPCA). 4 June 2025
Biotechnology
US clinical-stage biotech Sagimet Biosciences today reported denifanstat met all primary and secondary endpoints in a Phase III clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner Ascletis Bioscience in China. 4 June 2025
Biotechnology
Research news last week included Rocket Pharmaceuticals suffering a setback with its Phase II trial of RP-A501, which resulted in a patient death and a US Food and Drug Administration (FDA) hold on the study. Germany’s InflaRx announced it would discontinue development of vilobelimab in a dermatology condition due to futility. Regeneron and Sanofi presented mixed results for itepekimab, leading them to consider the future of the chronic obstructive pulmonary (COPD) therapy. Also of note, Japan’s Otsuka Pharma revealed that the US FDA has accepted its biologics license application (BLA) for sibeprenlimab for review as an immunoglobulin A nephropathy IgAN) treatment. 1 June 2025
Pharmaceutical
Japan’s Intellectual Property High Court has ordered Sawai Pharmaceutical and Fuso Pharmaceutical Industries to pay a total of over 20 billion yen ($138.5 million) in damages for infringing the patent of Toray Industries’ pruritus drug Remitch OD tablets (nalfurafine). 29 May 2025
Biotechnology
German drug developer InflaRx saw its US-traded shares plunge 55% to $0.82 in pre-market activity today, as it announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase III trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. 28 May 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025
Pharmaceutical
Danish privately-held drugmaker MC2 Therapeutics today announced the appointment of Trine Ahlgreen as chief executive (CEO). 27 May 2025
Biosimilars
The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025
Biotechnology
Italian drugmaker Philogen has announced its decision to voluntarily withdraw the application for marketing authorization to the European Medicines Agency (EMA) for Nidlegy(daromun), a biological investigational medicinal product which is intended to be used for the neoadjuvant treatment of adult patients with locally advanced fully resectable melanoma. 27 June 2025
Biotechnology
US biotech Nektar Therapeutics experienced a remarkable 130% increase in its share price, which reached $21.9, as it reported the successful outcome of a study related to atopic dermatitis. 24 June 2025
Biotechnology
New York-based Formation Bio, an AI-native pharma company focused on accelerating drug development, revealed that its subsidiary Libertas Bio has licensed gusacitinib to Sanofi, expanding the partnership between the companies. 24 June 2025
Biotechnology
Further expanding the indications for French pharma major Sanofi’s mega-blockbuster Dupixent (dupilumab), the US Food and Drug Administration (FDA) has approved the drug for the treatment of adult patients with bullous pemphigoid (BP). 20 June 2025
Biotechnology
Spanish skincare specialist Almirall has promised a key contribution at the International Congress of Dermatology (ICD), currently taking place in Rome, Italy. 19 June 2025
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has today recommended Spevigo (spesolimab) for the treatment of generalized pustular psoriasis (GPP) flares in adults in England and Wales. 18 June 2025
Biotechnology
Californian biotech Jasper Therapeutics presented data from the 180mg cohort of the company’s SPOTLIGHT Phase Ib/IIa study of subcutaneous briquilimab in adult participants with chronic inducible urticaria (CIndU) at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress. 16 June 2025
Biotechnology
US immunology specialist Celldex was trading 5% higher midday Friday, following on from 10% gains on Thursday. 13 June 2025
Biosimilars
South Korea’s biosimilar drug developer Samsung Bioepis has announced that the company has entered into a license, development and commercialization agreement with Nipro Corporation for multiple biosimilar candidates including SB17, a ustekinumab biosimilar candidate, in Japan. 9 June 2025
Biotechnology
Swiss skincare specialist Galderma has announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio (nemolizumab) in moderate-to-severe atopic dermatitis (AD). 9 June 2025
Biotechnology
US biotech Regeneron Pharmaceuticals and French pharma major Sanofi on Saturday presented results from the DISCOVER Phase IV, single-arm, open-label trial assessing Dupixent (dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis with skin of color. 9 June 2025
Pharmaceutical
The atopic dermatitis market across the seven major markets is forecast to nearly triple in value over the next decade, driven by advances in targeted therapies and a deeper understanding of disease mechanisms. 5 June 2025
Pharmaceutical
Danish dermatology specialist LEO Pharma has appointed Helle Hedegaard Juhl as executive vice president for global people and corporate affairs (GPCA). 4 June 2025
Biotechnology
US clinical-stage biotech Sagimet Biosciences today reported denifanstat met all primary and secondary endpoints in a Phase III clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner Ascletis Bioscience in China. 4 June 2025
Biotechnology
Research news last week included Rocket Pharmaceuticals suffering a setback with its Phase II trial of RP-A501, which resulted in a patient death and a US Food and Drug Administration (FDA) hold on the study. Germany’s InflaRx announced it would discontinue development of vilobelimab in a dermatology condition due to futility. Regeneron and Sanofi presented mixed results for itepekimab, leading them to consider the future of the chronic obstructive pulmonary (COPD) therapy. Also of note, Japan’s Otsuka Pharma revealed that the US FDA has accepted its biologics license application (BLA) for sibeprenlimab for review as an immunoglobulin A nephropathy IgAN) treatment. 1 June 2025
Pharmaceutical
Japan’s Intellectual Property High Court has ordered Sawai Pharmaceutical and Fuso Pharmaceutical Industries to pay a total of over 20 billion yen ($138.5 million) in damages for infringing the patent of Toray Industries’ pruritus drug Remitch OD tablets (nalfurafine). 29 May 2025
Biotechnology
German drug developer InflaRx saw its US-traded shares plunge 55% to $0.82 in pre-market activity today, as it announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase III trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. 28 May 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025
Pharmaceutical
Danish privately-held drugmaker MC2 Therapeutics today announced the appointment of Trine Ahlgreen as chief executive (CEO). 27 May 2025
Biosimilars
The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025
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