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Biotechnology
Continuing its impressive rise, Dupixent (dupilumab) has secured US Food and Drug Administration approval for prurigo nodularis, a debilitating skin condition. 29 September 2022
Biotechnology
Last month, Belgo-Dutch autoimmune diseases specialist argenx announced the European Commission (EC) approval of Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 19 September 2022
Biotechnology
Significant news last week included US pharma major Bristol Myers Squibb gaining Food and Drug Administration approval for its TYK2 inhibitor Sotyktu (deucravacitinib) for the treatment of plaque psoriasis. Shares of US biotech Akero skyrocketed last Tuesday when it released very positive Phase IIb results for its efruxifermin in the treatment of non-alcoholic steatohepatitis (NASH). Also, US pharma giant Pfizer released impressive new Phase III data on its pentavalent vaccine for meningococcal disease. US biotech Gilead Sciences last week entered into a settlement with several generic drugmakers relating to copy versions of its HIV drugs Descovy and Odefsey. 18 September 2022
Pharmaceutical
The Basel headquarters of pharma giant Novartis were raided at dawn earlier this week by the Swiss Competition Commission (COMCO). 15 September 2022
Biotechnology
Acelyrin, a late-stage clinical biopharma company focused on accelerating the delivery of transformative medicines in immunology, has announced a $300 million Series C financing to fund izokibep Phase III development in psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). 13 September 2022
Biotechnology
The US Food and Drug Administration (FDA) late on Friday announced the approval Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 12 September 2022
Pharmaceutical
US biotech Revance Therapeutics closed trading 22% higher on Thursday. 9 September 2022
Biotechnology
Spanish dermatology company Almirall has provided some detail on the results from a Phase III atopic dermatitis (AD) trial of lebrikizumab. 8 September 2022
Biotechnology
Privately-held Danish dermatology specialist LEO Pharma has presented new safety data on Adtralza (tralokinumab) at the European Academy of Dermatology and Venereology (EADV) Congress. 8 September 2022
Biotechnology
LifeArc revealed that its portfolio company Ducentis BioTherapeutics, a pre-clinical-stage UK biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases, has been acquired by Arcutis Biotherapeutics. 8 September 2022
Biosimilars
Competition for one of the best-selling medicines of all time is gaining traction, with new three-year data for Hadlima (adalimumab-bwwd), a biosimilar of adalimumab developed by Samsung Bioepis. 7 September 2022
Biotechnology
Belgium’s largest pharma company UCB has announced new three-year results from the BE BRIGHT open-label extension study of bimekizumab. 7 September 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Spevigo (spesolimab-sbzo), the first approved treatment option for generalized pustular psoriasis s (GPP) flares in adults, developed by German family-owned pharma major Boehringer Ingelheim. 2 September 2022
Biotechnology
Sino-American RNAi therapeutics company Sirnaomics has announced that the cohort receiving the 180μg dose in its Phase II trial of STP705 (cotsiranib) for cutaneous basal cell carcinoma (BCC) achieved a 100% complete response (CR), indicating the promising viability of the treatment. 30 August 2022
Biosimilars
The US Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 17 August 2022
Biotechnology
Shares of US biopharma company VYNE Therapeutics closed down 22.9% at $0.31 yesterday, having plunged as much as 35%, after it revealed results from the Phase IIa segment of a Phase Ib/IIa clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD) that failed to hit its goal. 11 August 2022
Biotechnology
Japanese drugmaker Maruho has launched the anti-interleukin (IL)-31 receptor A humanized monoclonal antibody Mitchga (nemolizumab [genetical recombination]) subcutaneous Injection 60mg syringes for the treatment of itching associated with atopic dermatitis (only when existing treatment is insufficiently effective). 8 August 2022
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma has announced the appointment of Sven Hauptmann as its new executive vice president of global product supply. 4 August 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Zoryve (roflumilast) cream 0.3% for the treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age or older. 30 July 2022
Pharmaceutical
Belgium’s largest pharma company UCB this morning posted financial results for the first half of 2022, which it described as “strong,” but investors were not convinced, sending the firm’s shares more than 4% lower to 77.92 euros. 28 July 2022
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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