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Biotechnology
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
Biotechnology
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
Biotechnology
Aclaris Therapeutics has announced an exclusive licensing agreement with Biosion for broad rights to two new antibodies. 19 November 2024
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biosimilars
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
Pharmaceutical
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
Biotechnology
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
Biotechnology
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
Biosimilars
Bio-Thera Solutions and Hungary’s Gedeon Richter have reached an exclusive commercialization and license agreement. 14 October 2024
Biotechnology
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Pharmaceutical
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
Pharmaceutical
US dermatology specialist Verrica Pharmaceuticals announced the closing of the previously announced $125 million debt financing with OrbiMed, a leading healthcare investment firm. 27 July 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Ycanth (cantharidin), a drug/device for the topical treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. 25 July 2023
Pharmaceutical
Rising sales at Spanish drugmaker Almirall in the first half of 2023 were not matched by earnings figures. 24 July 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 10 novel medicines, as well as some biosimilars and indication extensions, for approval at its July 2023 meeting. 21 July 2023
Biotechnology
Privately-held Recludix Pharma has agreed a deal with French pharma major Sanofi to develop and commercialize oral small molecule STAT6 (signal transducer and activator of transcription 6) inhibitors for immunological and inflammatory (I&I) diseases. 21 July 2023
Biotechnology
The European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), submitted by Belgium’s largest pharma company UCB. 18 July 2023
Pharmaceutical
Dermatology specialist Journey Medical has announced positive top-line results from two Phase III trials of its rosacea candidate, DFD-29, a formulation of minocycline hydrochloride. 11 July 2023
Biotechnology
Danish pharma and medical equipment maker Coloplast on Friday revealed it has entered into an agreement to acquire Kerecis, an Iceland based developer of biologics for the wound care market, using. fish skin to develop tissue-transplant products. 8 July 2023
Biotechnology
Spanish skincare specialist Almirall has announced positive results from a real-world study of Ilumetri (tildrakizumab) at the 25th World Congress of Dermatology. 7 July 2023
Biotechnology
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 5 July 2023
Biotechnology
The Johnson & Johnson subsidiary Janssen has announced positive top-line results from its Phase IIb FRONTIER 1 trial of the first and only oral interleukin-23 receptor (IL-23R) antagonist peptide, JNJ-2113, in moderate-to-severe plaque psoriasis. 5 July 2023
Biotechnology
German family-owned pharma major Boehringer Ingelheim today presented new late-breaking data from the EFFISAYIL trial showing that patients receiving the highest dose of spesolimab experienced significantly reduced generalized pustular psoriasis (GPP) flares by 84% over 48 weeks compared to placebo (hazard ratio 0.157; 95% confidence interval 0.05–0.54; p=0.0005). 4 July 2023
Biosimilars
With the block on biosimilar versions of AbbVie’s (NYSE: ABBV) mega blockbuster Humira (adalimumab) now removed in the USA, the weekend witnessed the launch of three copycat products in the American market. 3 July 2023
Biotechnology
US drug major Bristol Myers Squibb’s Sotyktu (deucravacitinib), a once-daily oral tablet, has been recommended for use on the National Health Service (NHS) in England as an option for treating certain adults with moderate to severe plaque psoriasis. 28 June 2023
Biotechnology
The primary endpoint was met in a Phase IIb study (STREAM-AD) of amlitelimab (formerly KY1005) in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach. 27 June 2023
Biotechnology
US traded shares of Swiss biotech MoonLake Immunotherapeutics leapt almost 79% to $46.58 this morning, after the inflammatory diseases specialist announced positive top-line results from its global Phase II MIRA trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). 26 June 2023
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Litfulo (ritlecitinib), a once-daily oral treatment, for individuals aged 12 years and older with severe alopecia areata. 24 June 2023
Biosimilars
German family-owned pharma major Boehringer Ingelheim has revealed that Optum Rx, a leading pharmacy benefit manager and subsidiary of UnitedHealth Group, will place Cyltezo (adalimumab-adbm) on its commercial formulary as a preferred brand, which covers more than 66 million members. 24 June 2023
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma has appointed Kreesten Meldgaard Madsen as chief development officer and, effective Tuesday, he joined LEO Pharma’s global leadership team (GLT). 21 June 2023
Pharmaceutical
Spanish dermatology-focused drugmaker Almirall has launched a non pre-emptive share capital increase for a total aggregate amount (including nominal value and share issue premium) of around 200 million euros, by issuing more than 24 million new ordinary shares at 8.20 euros. 14 June 2023
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