The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM; USA, France, Germany, Italy, Spain, UK and Japan). 20 November 2024
Johnson & Johnson and partner Protagonist Therapeutics have reported positive topline results from two Phase III studies testing a first-in-class oral peptide. 20 November 2024
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Danish dermatology specialist LEO Pharma today announced that Swissmedic, Switzerland’s national regulatory agency for approving and overseeing therapeutic products, has granted marketing approval for Anzupgo (delgocitinib) cream. 14 November 2024
Rubedo Life Sciences, a US biopharma developing first-in-class therapies targeting senescent cells which drive age-related diseases, has announced the appointment of Frederick C Beddingfield III, as chief executive officer and board director. 11 November 2024
Almirall, the Spain-based biopharma, reported a 7.9% increase in net sales for the first nine months of 2024, reaching 728 million euros ($775 million), and an EBITDA rise of 2.9% to $152 million. 11 November 2024
New research has been published in the Journal of Allergy and Clinical Immunology (JACI) that shows treatment with amlitelimab, an anti-OX40 ligand antibody, significantly reduced symptoms of atopic dermatitis (AD) and was maintained even after treatment stopped. 9 November 2024
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Denmark’s privately-held dermatology specialist LEO Pharma and Japan’s Kyowa Kirin have revealed that they will terminate the distribution and co-promotion agreement for the psoriasis vulgaris treatment Dovobet Ointment, Gel, and Foam (calcipotriol hydrate / betamethasone dipropionate) in Japan on December 31, 2024. 1 November 2024
Regeneron Pharmaceuticals today announced financial results for the third quarter of 2024 that beat expectations, but still saw its share price fall more than 6% to $866 in early trading. 31 October 2024
Treatment with Tremfya (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment, says US healthcare giant Johnson & Johnson. 25 October 2024
New results show Eli Lilly Ebglyss (lebrikizumab-lbkz) improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with Dupixent (dupilumab). 25 October 2024
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU). 14 October 2024
The US Food and Drug Administration (FDA) has approved a 2mL pre-filled syringe and pre-filled autoinjector, each containing 320mg of Belgian drugmaker UCB’s Bimzelx (bimekizumab-bkzx), to treat psoriasis. 14 October 2024
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Beijing’s InnoCare Pharma has announced encouraging Phase II results for its novel TYK2 inhibitor, ICP-488, aimed at treating moderate-to-severe plaque psoriasis. 10 October 2024
Spanish dermatology specialist Almirall and etherna, a privately-held Belgian mRNA/lipid nanoparticle (LNP) technology platform company, have announced a collaboration. 12 December 2023
Privately-held Swiss dermatology company Galderma has turned a frown into a smile in sharing the latest news on its drug relabotulinumtoxinA (QM-1114), a novel liquid formulation botulinum toxin A. 30 November 2023
Roivant Sciences’ shares fell 4.7% to $8.70 in early morning trading yesterday, after it announced the Phase II study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint. 28 November 2023
Australian dermatology specialist Botanix Pharmaceuticals saw its shares dip 3.2% to A$0.15 this morning, despite announcing receipt of firm commitments for $13.5 million (US) via an institutional placement, with proceeds to support preparation for commercial launch activities for its lead product Sofdra (sofpironium bromide) gel. 27 November 2023
Evelo Biosciences revealed in a stock exchange filing that, in the best interests of the company and its stockholders, the business will be dissolved. 22 November 2023
Two subsidiaries of Connect Biopharma are to work together with Simcere Pharmaceutical on the development of rademikibart in China, Hong Kong, Macau and Taiwan. 22 November 2023
Almirall has won European Commission (EC) approval for Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. 17 November 2023
Spanish dermatology specialist Almirall and US generative AI drug creation company Absci Corporation have announced a drug discovery partnership. 14 November 2023
Aclaris Therapeutics stock has taken a battering again, after the Phase IIb ATI-450-RA-202 trial was found to have missed its primary and secondary endpoints. 14 November 2023
UK-based Kelso Pharma today revealed it has taken its first step in its European expansion strategy by agreeing to acquire Italy’s Velit Biopharma which, like Kelso is a specialty pharma company. 13 November 2023
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines and two biosimilars for approval at its November 2023 meeting. 11 November 2023
Indian biotech firm Biocon says that its subsidiary, Biocon Biologics, has inked a deal with Eris Lifesciences which will see it divest its dermatology and nephrology branded formulations business unit in India that is mostly comprised of its legacy small-molecule brands. 9 November 2023
Swiss biotech MoonLake Immunotherapeutics has announced positive top-line results from its global Phase II ARGO trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with active psoriatic arthritis (PsA). 6 November 2023
San Diego, USA-based biotech AnaptysBio’s ground breaking Phase III trial results for imsidolimab, a novel inhibitor, bring renewed hope to patients battling generalized pustular psoriasis (GPP). 3 November 2023
Adding to recent regulatory approvals in the USA and European Union, pharma giant Pfizer can now add the UK to the geographies where its alopecia treatment can be marketed. 1 November 2023
The US Food and Drug Administration (FDA) yesterday announced it has approved US biotech major Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. 1 November 2023
Swiss pharma major Novartis has secured another approval from the US regulator for Cosentyx (secukinumab), a biologic which blocks the IL-17A cytokine. 1 November 2023