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Biosimilars
Icelandic firm Alvotech and the US unit of Israel’s Teva Pharmaceutical Industries today revealed they have reached a settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab) in the USA. 12 June 2023
Biotechnology
The European Commission (EC) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. 7 June 2023
Biotechnology
Belgium’s largest pharma company UCB today revealed that its developmental treatment for adults with hidradenitis suppurativa (HS) has been granted Promising Innovative Medicine (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). 5 June 2023
Biosimilars
US biosimilars developer Coherus BioSciences saw its share rise 5% to $4.05 pre-market, after it announced it will launch Yusimry (adalimumab-aqvh) next month. 2 June 2023
Biotechnology
Belgium’s largest drugmaker UCB will present new long-term 52-week data from three Phase III studies of bimekizumab at the 2023 meeting of the European Congress of Rheumatology (EULAR). 31 May 2023
Biotechnology
Italian-Swiss biotech Philogen has entered into a licensing agreement leading Indian drugmaker Sun Pharmaceuticals for commercializing Philogen’s specialty product, Nidlegy (daromun), in the territories of Europe, Australia and New Zealand. 30 May 2023
Biotechnology
Industry analyst GlobalData has highlighted research showing the potential of Janssen’s Tremfya (guselkumab) in the treatment of psoriasis. 30 May 2023
Generics
Leading Indian drugmaker Sun Pharmaceutical Industries has reported financials for the full year ending March 31, 2023 (FY23). 30 May 2023
Biosimilars
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare. 26 May 2023
Biotechnology
Ichthyosis is a heterogenous group of disorders characterized by dry, itchy skin that appears scaly and rough like fish scales.1,2 The first case of ichthyosis was described 24 May 2023
Biotechnology
Positive Phase III results for Sanofi’s trailblazing biologic Dupixent (dupilumab) could open up a significant opportunity in a new treatment setting. 22 May 2023
Biotechnology
The US Food and Drug Administration on Friday approved Vyjuvek (beremagene geperpavec-svdt), a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients six months and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. 22 May 2023
Biotechnology
US biotech Sarepta Therapeutics won a narrow vote from a Food and drug Administration (FDA) advisory committee to grant accelerated approval for its Duchenne muscular dystrophy candidate SRP-9001 (delandistrogene moxeparvovec). On the M&A front, last Tuesday, the US Federal Trade Commission (FTC) announced that it has filed a lawsuit to prevent Amgen from acquiring fellow US biotech Horizon Therapeutics, citing monopoly concerns, especially with regard to Krystexxa and Tepezza. Research news included Roivant subsidiary Dermavant Sciences announcing positive Phase III results for its Vtama in severe atopic dermatitis, and Australia’s Immutep released positive Phase II data on its LAG-3 immunotherapy eftilagimod in lung cancer. 21 May 2023
Pharmaceutical
CSL Vifor, the iron deficiency and nephrology specialist owned by Australia’s CSL, has announced an update from the UK. 18 May 2023
Biotechnology
UK-based Senisca, a biotech company developing RNA-based therapeutics to reverse cellular senescence and target age-related disease, has announced an expansion of its leadership team. 18 May 2023
Pharmaceutical
Dermavant Sciences, an immuno-dermatology-focused subsidiary of Switzerland-based Roivant Sciences, today announced positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase III studies to evaluate the efficacy and safety of topical Vtama (tapinarof) cream. 16 May 2023
Biotechnology
Adding to regulatory approvals in the USA and European Union, US pharma major Bristol Myers Squibb said today that its first drug in psoriasis, Sotyktu (deucravacitinib), has been granted Marketing Authorisation (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA). 15 May 2023
Biotechnology
The recent European Commission approval for Sotyktu (deucravacitinib), US pharma major Bristol Myers Squibb’s first-in-class, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for adults with moderate-to-severe plaque psoriasis (PsO), has elicited comment from a leading data and analytics firm. 11 May 2023
Biotechnology
Spanish dermatology company Almirall has recorded net sales of 230 million euros ($253 million) in the first quarter of 2023, a 6% increase, and net income of 7.7 million euros. 9 May 2023
Biotechnology
Regeneron was trading 7% lower on Thursday lunchtime following the presentation of its first-quarter 2023 financial results and latest guidance for the full-year. 4 May 2023
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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