Dermatologicals
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Biotechnology
Danish dermatology specialist LEO Pharma has announced 16-week results of a 52-week monotherapy trial showing Adtralza (tralokinumab) significantly improved primary and secondary measurements of efficacy among adolescents (aged 12 to 17) with moderate-to-severe atopic dermatitis. 25 October 2021
Biotechnology
A Phase III trial evaluating Dupixent (dupilumab) in adults with uncontrolled prurigo nodularis has met its primary and all key secondary endpoints. 22 October 2021
Biosimilars
China’s Bio-Thera Solutions has reached a licensing and supply agreements with Pharmapark for BAT2206, its ustekinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other Commonwealth of Independent States (CIS) countries. 18 October 2021
Biotechnology
Following its meetings over October 11-14, the European Medicines Agency’s human medicines committee, the CHMP, today recommended five novel medicines and one generic for approval. 15 October 2021
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with inadequate response to existing therapies. 7 October 2021
Biotechnology
Swiss biotech MoonLake Immunotherapeutics and Helix Acquisition Corp, a special purpose acquisition company (SPAC) sponsored by Cormorant Asset Management, today announced they have entered into a definitive business combination agreement. 4 October 2021
Pharmaceutical
Shares of Ireland-incorporated drugmaker Cosmo Pharmaceuticals fell 4.4% to 76 Swiss francs this morning after it revealed it has agreed to buy back Italy-based Cassiopea, the dermatologics company it spun out in 2015. 4 October 2021
Biotechnology
US biotech Incyte has announced the full 24-week results from its pivotal Phase III TRuE-V clinical trial program investigating Opzelura (ruxolitinib) cream, a topical JAK inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. 4 October 2021
Generics
Three generic pharmaceutical manufacturers, Taro Pharmaceuticals USA, Sandoz, the biosimilars and generics business of Novartis and Apotex Corp, have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act arising from conspiracies to fix the price of various generic drugs. 2 October 2021
Biotechnology
The recent ruling in favor of upholding Amgen’s patents for its phosphodiesterase inhibitor Otezla (apremilast) until its patent expiry in 2028 is an important safeguard for US biotech giant Amgen. 1 October 2021
Biotechnology
Danish dermatology specialist LEO Pharma today announced results showing that after two years of continuous treatment with Adtralza (tralokinumab), adult patients with moderate-to-severe atopic dermatitis maintained improvements in signs and symptoms, itch severity and sleep interference. 30 September 2021
Biotechnology
Positive results from a Phase IIa study evaluating the safety and efficacy of amlitelimab (formerly KY1005), a human monoclonal antibody targeting key immune system regulator OX40-Ligand, were presented as a late-breaker today at the European Academy of Dermatology and Venerology (EADV) 2021 Virtual Congress. 30 September 2021
Biotechnology
Swiss independent dermatology specialist Galderma today announced the presentation of new Phase II data supporting the efficacy of its investigational monoclonal antibody, nemolizumab, at the virtual 30th EADV congress now taking place. 29 September 2021
Pharmaceutical
Almirall, the Spanish dermatology specialist, today announced the commercial launch of its Klisyri (tirbanibulin) ointment in both Germany and the UK. 27 September 2021
Biotechnology
News in the past week saw the US Food and Drug Administration announcing a number of significant approvals. First, an FDA advisory committee voted to limit booster COVID-19 jabs with Pfizer/BioNTech’s Comirnaty only for older and at-risk people, that was later countered by a different decision from the CDC. Also, Denmark’s Genmab and US biotech Seagen gained FDA approval for their cervical cancer drug Tivdak (tisotumab vedotin). US biotech Incyte received FDA backing for Opzelura, its topical formulation of Jakafi, for the treatment of atopic dermatitis. And Incyte also received an additional approval form the US regulator for its top-selling drug Jakafi for chronic graft-versus -host disease. Also of note, French ophthalmology specialist Nicox announced negative results from a mid-stage trial of its NCX-4251 in the treatment of blepharitis. 26 September 2021
Biotechnology
UK biotech Immunocore Holdings has announced that data from a Phase III trial comparing tebentafusp with investigator’s choice in first-line metastatic uveal melanoma (mUM) has been published in The New England Journal of Medicine (NEJM). 23 September 2021
Biotechnology
Delaware-based biopharma Incyte has announced an important US approval. 22 September 2021
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in Great Britain for Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor. 14 September 2021
Pharmaceutical
Binnopharm Group, a Russian pharmaceutical producer will invest more than 2.5 billion roubles ($33 million) in the development of new drugs within the next several years, according to the company which was launched in February this year. 14 September 2021
Biotechnology
French drugmaker Sanofi has announced that the Phase III PEGASUS trial evaluating rilzabrutinib to treat pemphigus, a rare autoimmune skin condition, did not meet its primary or key secondary endpoints. 9 September 2021
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
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