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Biotechnology
Colorado, USA-based biotech Enveda Biosciences, which is using AI to translate nature into new medicines, has announced an oversubscribed $130 million Series C funding round led by Kinnevik and FPV. 22 November 2024
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
Generics
Japanese drugmaker Chugai Pharmaceutical says that, on December 24, the Tokyo District Court granted Chugai an overall victory for the first instance demanding the suspension of patent infringement of the manufacturing process patent owned by Chugai (Patent No 3310301), related to Oxarol (maxacalcitol) ointment. 29 December 2014
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab) for the treatment of both psoriasis vulgaris and psoriatic arthritis. 26 December 2014
Pharmaceutical
The Food and Drug Administration has approved Israeli generics giant Teva Pharmaceutical Industries’ Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. 24 December 2014
Biotechnology
RNA technology specialist RXi Pharmaceuticals Corp has entered into a global licensing agreement with Hapten Pharmaceuticals for Samcyprone. 19 December 2014
Pharmaceutical
Swiss drug major Novartis announced that the Phase IIIb CLEAR study for Cosentyx (secukinumab) met its primary endpoint. 15 December 2014
Biotechnology
The first biologic to treat atopic dermatitis, French pharma major Sanofi (Euronext: SAN) and US biotech firm Regeneron Pharmaceuticals’(Nasdaq: REGN) dupilumab, could launch in the USA by second-quarter 2017. 4 December 2014
Pharmaceutical
Amgen/AstraZeneca's brodalumab trial meets primary endpoints for moderate-to-severe plaque psoriasis
USA-based Amgen, the world’s leading independent biotech firm, and Anglo-Swedish drug major AstraZeneca have concluded their AMAGINE-2 Phase III trial of two doses of brodalumab, finding that it met its primary endpoints in moderate-to-severe plaque psoriasis. 26 November 2014
Biotechnology
US biotech Regeneron Pharmaceuticals and French pharma major Sanofi have said that the US Food and Drug Administration has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD). 25 November 2014
Pharmaceutical
A total of 10 new medicines have been recommended for approval at the November 2014 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 22 November 2014
Biotechnology
Swiss pharma giant Novartis this morning revealed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of its Cosentyx (secukinumab). 21 November 2014
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation to French pharma major Sanofi and Regeneron’s dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. 20 November 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Swiss pharma giant Novartis to provide more information on its Xolair (omalizumab), a drug to treat chronic hives. 19 November 2014
Biotechnology
AstraZeneca and Amgen's brodalumab achieves primary endpoint in Phase III trial for plaque psoriasis
Anglo-Swedish drug major AstraZeneca and USA-based Amgen, the world’s largest independent biotech firm, say that a Phase III trial evaluating two doses of brodalumab in more than 1,800 patients with moderate-to-severe plaque psoriasis, when compared with Stelara (ustekinumab) and placebo at week 12, has met its primary endpoint. 12 November 2014
Pharmaceutical
Independent Danish dermatology specialist Leo Pharma has demonstrated significant improvement in psoriasis disease severity in trials of its Daivobet gel (calcipotriol and betamethasone). 29 October 2014
Pharmaceutical
The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration yesterday voted unanimously to support the approval of Swiss pharma major Novartis’ secukinumab (AIN457), a selective interleukin-17A (IL-17A) inhibitor. 21 October 2014
Pharmaceutical
US biotech company Celgene took a practical approach to raising awareness of psoriasis and psoriatic arthritis (PA) during the annual meeting of the European Academy of Dermatology and Venereology (EADV) in Amsterdam, the Netherlands, last week. 14 October 2014
Biotechnology
Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients aged 12 to 17 years old. 13 October 2014
Pharmaceutical
US pharma company AbbVie has reported new data with its mega blockbuster arthritis drug Humira (adalimumab) that could lead to another indication for the product. 13 October 2014
Pharmaceutical
Swiss drug major Novartis has reported data from a Phase III trial showing consistent efficacy in clearing psoriasis with AIN457 (secukinumab), regardless of how bad patients’ disease is at the start of treatment. 10 October 2014
Biosimilars
US biotech major Amgen says its Phase III study evaluating the efficacy and safety of its biosimilar candidate ABP 501 compared with AbbVie’s blockbuster drug Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint. 9 October 2014
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