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Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended Cosentyx (secukinumab) as an option for treating moderate to severe plaque psoriasis in people aged six to 17 years who have not responded to other forms of systemic treatment or for whom these options were contraindicated or not tolerated. 6 September 2021
Pharmaceutical
Shares in Forte Biosciences plummeted 81.6% to $5.25 pre-market today, after it revealed late Thursday that top-line data from its Phase II clinical trial of FB-401 for the treatment of atopic dermatitis failed to meet statistical significance. 3 September 2021
Biotechnology
The JAK1 inhibitor abrocitinib could become a stellar asset for US pharma giant Pfizer, new eczema trial results show. 31 August 2021
Biotechnology
A pivotal Phase III trial evaluating Dupixent (dupilumab) for the treatment of children aged six months to five years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. 30 August 2021
Biosimilars
China’s Bio-Thera Solutions and London-listed Hikma Pharmaceuticals have entered into a commercialization and license agreement to commercialize BAT2206, a monoclonal antibody that is a proposed biosimilar referencing Johnson & Johnson’s Stelara (ustekinumab), in the USA. 28 August 2021
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Belgium’s largest drugmaker UCB’s Bimzelx (bimekizumab) as an option for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy. 27 August 2021
Pharmaceutical
Bain Capital has sold its 42.9%-plus convertible bonds in Kosdaq-listed botulinum toxin maker Hugel, reported the Korea JoongAng Daily and other media. 26 August 2021
Biotechnology
The European Commission (EC) has approved Rinvoq (upadacitinib), an oral, selective and reversible JAK inhibitor from US pharma major AbbVie, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. 25 August 2021
Biotechnology
Boston, USA-based non-profit The Institute for Clinical and Economic Review (ICER) has released its final report into the cost-effectiveness of a range of atopic dermatitis (AD) therapies. 18 August 2021
Biotechnology
The China National Medical Products Administration (NMPA) has further approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in pediatric patients. 17 August 2021
Biotechnology
Lebrikizumab led to significant improvements with at least 75% skin clearance in more than half of people with moderate-to-severe atopic dermatitis (AD), as measured by EASI, in ADvocate 1 and ADvocate 2 Phase III clinical trials announced today. 16 August 2021
Biotechnology
Belgium’s largest drugmaker UCB recently presented new interim data from BE BRIGHT, an open-label extension (OLE) trial of an interleukin (IL)-17A/F inhibitor bimekizumab for plaque psoriasis (PsO), at the 2021 American Academy of Dermatology (AAD) Summer Meeting. 16 August 2021
Biotechnology
Swiss clinical-stage biotech MoonLake Immunotherapeutics today announced the appointment of Simon Sturge as chairman. 10 August 2021
Biotechnology
US biotech Regeneron Pharmaceuticals today announced financial results for the second quarter of 2021 that significantly beat analysts’ forecasts, sending the firm’s shares up 2.6% to $595.87 in pre-market trading. 5 August 2021
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination recommending UCB’s bimekizumab as an option for adults with severe plaque psoriasis. 3 August 2021
Pharmaceutical
ParaPRO, a specialty pharma company focused on innovative anti-parasitic treatments, has announced the availability of Natroba (spinosad) Topical Suspension, 0.9%, the first product for scabies to be approved by the US Food and Drug Administration (FDA) in more than 30 years. 3 August 2021
Biosimilars
Indian pharmaceutical companies are set to gain from the US Food and Drug Administration's changed stance on biosimilar versions of biological medicines. With the US FDA approving a biosimilar interchangeable insulin product for the treatment of diabetes for the first time in the country, the doors appear to have been opened for generic players, with many considering it a shot in the arm, reports The Pharma Letter’s India correspondent. 2 August 2021
Pharmaceutical
French drugmaker Sanofi became the latest pharma company to announce a positive set of second quarter results on Thursday. 29 July 2021
Biotechnology
The atopic dermatitis (AD) space will see a total transformation over the next decade due to intense clinical activity, says analyst. 28 July 2021
Pharmaceutical
Shares in Spanish dermatology specialist Almirall were down by nearly 12% as Monday afternoon’s trading neared its end. 26 July 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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