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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
Swiss pharma giant Novartis has announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU). 20 December 2021
Biotechnology
The US Food and Drug Administration has accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of generalized pustular psoriasis (GPP) flares, that was submitted by German family-owned pharma major Boehringer Ingelheim. 15 December 2021
Biotechnology
US biopharma Incyte has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura), a topical JAK inhibitor, as a potential treatment for adolescents and adults with vitiligo. 15 December 2021
Biotechnology
Ichnos Sciences, a biotechnology company 100% owned by India’s Glenmark Pharmaceuticals, and Spanish drugmaker Almirall have entered into an exclusive licensing agreement for the interleukin (IL)-1RAP antagonist ISB 880. 14 December 2021
Biosimilars
Hyphens Pharma International, Singapore’s leading specialty pharmaceutical and consumer healthcare group, says that its subsidiary, Hyphens Pharma Pte has signed an exclusive license and supply agreement with DKSH’s subsidiary, Favorex Pte to commercialize the ustekinumab biosimilar produced by Alvotech, in Singapore, Malaysia, and the Philippines. 14 December 2021
Biotechnology
The European Commission (EC) has approved the 100mg and 200mg doses of Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy, US pharma giant Pfizer announced today. 10 December 2021
Pharmaceutical
Market research from industry commentator GlobalData finds that new creams and tablets are on the way in plaque psoriasis (PsO). 9 December 2021
Biotechnology
Odyssey Acquisition, a Euronext Amsterdam-listed special-purpose acquisition company (SPAC), and British biotech BenevolentAI, a clinical-stage AI drug discovery company, today announced that they have entered into a definitive agreement for a business combination. 7 December 2021
Biotechnology
M&A featured in last week’s news, with US cancer specialist Blueprint Medicines last Monday revealing it was acquiring Lengo Therapeutics for up to $465 million to bolster its lung cancer drug pipeline. Also, French pharma major Sanofi last Wednesday announced it was buying Austrian biotech firm Origimm to expand its vaccines R&D portfolio along with its acne candidate ORI-001. On the research front, US gene therapy company Krystal Biotech soared last Monday after it released positive clinical trial results for its Vyjuvek (beremagene geperpavec) in the treatment of epidermolysis bullosa. Also, Quell Therapeutics raised $156 million in a Series B financing, with the proceeds to be used to accelerate research on its QEL-001 CAR-T reg cell therapy. 5 December 2021
Generics
Teva launches authorized generic of Epiduo Forte Gel in USA 1 December 2021
Biotechnology
Acquisition hungry Sanofi has announced the fifth such deal for this year, revealing that it has reached agreement to buy Origimm Biotechnology. 1 December 2021
Pharmaceutical
Privately-held Danish medical dermatology specialist LEO Pharma today said that its president and chief executive of two years, Catherine Mazzacco, has resigned from the position and will be leaving the company as of today. 30 November 2021
Biotechnology
Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib to treat moderate to severe plaque psoriasis. 30 November 2021
Biotechnology
US gene therapy company Krystal Biotech saw its shares skyrocket more than 120% to $88.24 by close of trading yesterday, after it announced positive top-line results from the pivotal GEM-3 trial of investigational beremagene geperpavec (B-VEC), now known as Vyjuvek, for the treatment of dystrophic epidermolysis bullosa (dystrophic EB). 30 November 2021
Pharmaceutical
The US Food and Drug Administration has extended the review period for the New Drug Application (NDA) for Oleogel-S10 for the treatment of the cutaneous manifestations of junctional and dystrophic bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. 24 November 2021
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) regularly calls out drugmakers in certain therapy areas for introducing drugs to the market at prices that exceed its estimates of what they are worth. 16 November 2021
Pharmaceutical
Shares in Spanish dermatology specialist Almirall were more than 10% down as European trading entered its final quarter on Monday. 15 November 2021
Biotechnology
US biotech company Regeneron Pharmaceuticals reported a 51% increase in its third-quarter 2021 revenue when announcing its latest financial results on Thursday. 5 November 2021
Pharmaceutical
French drugmaker Sanofi has beaten forecasts with its third-quarter 2021 earnings figures. 28 October 2021
Pharmaceutical
US pharma major Eli Lilly today reported third-quarter 2021 financial results that did not live up to all analysts’ earnings hopes, despite better-than-expected top-line growth, sending the firm’s shares down 1.9% to $240.31 in early trading. 26 October 2021
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