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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
Biotechnology
Danish dermatology company LEO Pharma has announced positive results from the Phase III DELTA 3 trial, an open-label extension study of its candidate delgocitinib. 30 October 2023
Pharmaceutical
Novartis has lifted its 2023 earnings forecast for the third time. 24 October 2023
article
Featuring in last week’s news, Swiss firm MoonLake Immunotherapies announced new Phase II MIRA study data showing that its antibody sonelokimab further improved response rate in hidradenitis suppurativa. Last Tuesday, Monte Rosa Therapeutics announced a potentially $2 billion licensing deal with Roche for its molecular glue degrader-based medicine, and also released early-stage results for its cancer candidate MRT-2359. Japan’s Daiichi Sankyo signed a mega bucks deal with US pharma giant Merck & Co for three antibody drug conjugates (ADCs) that could potentially be worth $22 billion. On the M&A front, Eli Lilly agreed to acquire French pre-clinical stage biotech Mablink Biosciences and its lead candidate MBK-103 for an undisclosed amount. 22 October 2023
Biotechnology
UCB has won two approvals from the US Food and Drug Administration, one for a new first-in-class rare disease med and another, for Bimzelx (bimekizumab-bkzx), bringing a new option for Americans with plaque psoriasis. 18 October 2023
Biotechnology
Shares USA-based clinical-stage biotech Evelo Biosciences plummeted 59% to $1.20 yesterday, as it announced disappointing top-line results from its Phase II clinical study with EDP2939 in moderate psoriasis. 18 October 2023
Biotechnology
Privately-held, China-based biopharma company EpimAb Biotherapeutics has inked a deal with Spanish Dermatology company Almirall. 16 October 2023
Biotechnology
Swiss biotech firm MoonLake Immunotherapeutics saw its US traded shares rise pre-market, after it announced positive 24-week top-line results from its global Phase II MIRA trial. 16 October 2023
Biotechnology
Positive results from the Phase III SEQUENCE study show the benefit of AbbVie’s blockbuster biologic Skyrizi (risankizumab) in Crohn's disease. 16 October 2023
Biotechnology
Belgian drugmaker UCB has announced the first analyses of pooled data from two Phase III bimekizumab studies (BE HEARD I and BE HEARD II) in moderate to severe hidradenitis suppurativa (HS). 13 October 2023
Biotechnology
Swiss independent dermatology specialist Galderma has released positive data from three pivotal Phase III trials in atopic dermatitis and prurigo nodularis – ARCADIA 1 and 2 and OLYMPIA 1, respectively. 13 October 2023
Biotechnology
At the European Academy of Dermatology and Venerology (EADV) congress in Berlin, AbbVie is presenting positive results from the Phase IIb NCT04927975 study. 12 October 2023
Biosimilars
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Icelandic firm Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Johnson & Johnson Stelara (ustekinumab). 12 October 2023
Biotechnology
Swedish biotech Promore Pharma will soon run out of money, and has begun liquidation proceedings, the company announced. 12 October 2023
Biotechnology
San Diego, USA-based biotech AnaptysBio saw its shares edge up 3.6% to $19.95, after it released results from the Phase III GEMINI-1 trial evaluating the safety and efficacy of imsidolimab (interleukin (IL)-36R MAb) in patients with generalized pustular psoriasis (GPP) flares. 10 October 2023
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma has named Professor Alexander Egeberg, a globally recognized dermatologist and top key opinion leader as the company’s new vice president, head of global medical affairs. 9 October 2023
Pharmaceutical
Leading Indian drugmaker Sun Pharmaceutical Industries today revealed that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. 6 October 2023
Biotechnology
US immuno-dermatology specialist biotech Dermavant Sciences, a subsidiary of Roivant Sciences, has appointed John Darden as vice president of marketing. 6 October 2023
Biotechnology
Privately-held Swiss dermatology company Galderma has announced some bad news relating to its pending Biologics License Application (BLA) for relabotulinumtoxinA (QM-1114) to the US Food and Drug Administration (FDA). 3 October 2023
Biotechnology
The US Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema), the drug’s developer, US pharma major Eli Lilly, announced yesterday. 3 October 2023
Pharmaceutical
Australian dermatology company Botanix today revealed it has received a communication from the US Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) submission for sofpironium bromide (SB) gel, 15%. 26 September 2023
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