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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
Pharmaceutical
The US Food and Drug Administration has approved KYTHERA Biopharmaceuticals’ Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. 30 April 2015
Pharmaceutical
USA-based Antares Pharma says it has regained US marketing rights to Otrexup (methotrexate) injection for subcutaneous use for the psoriasis indication through the termination of an exclusive promotion and marketing agreement with independent Danish dermatology specialist Leo Pharma 30 April 2015
Biotechnology
US pharma major Eli Lilly says that the investigational drug ixekizumab was statistically superior to placebo in the treatment of patients with active psoriatic arthritis (PsA), as demonstrated by the proportion of patients achieving an ACR 20 response. 20 April 2015
Pharmaceutical
Indian drug major Dr Reddy's Laboratories and its subsidiary, Promius Pharma, have filed three 505(b)(2) New Drug Applications with the US Food and Drug Administration. 8 April 2015
Biotechnology
US clinical-stage firm Brickell Biotech has signed an exclusive license and development agreement for BBI-4000 with Japanese drugmaker Kaken Pharmaceutical. 2 April 2015
Pharmaceutical
In line with its strategic focus, UCB has entered an agreement with Indian drugmaker Dr Reddy’s (BSE: 500359) to sell its established brands. 1 April 2015
Biotechnology
Shares in inflammatory and cancer specialist Can-Fite slid more than 60% following the announcement that its experimental CF101 did not meet its primary endpoint in a Phase II/III study. 31 March 2015
Pharmaceutical
Swiss drugmaker Galderma has received a positive outcome of the European Decentralized Procedure (DCP) for Soolantra (ivermectin) Cream 10mg/g for the once-daily topical treatment of inflammatory lesions of papulopustular rosacea in adult patients. 29 March 2015
Biotechnology
Dermatology biotech company Signum Dermalogix has entered into an agreement with Dermata Therapeutics to develop a tropical product to treat rosacea. 25 March 2015
Pharmaceutical
Novartis, Boehringer Ingelheim and Celgene have presented positive data on their dermatology products at the American Academy of Dermatology meeting in San Francisco this weekend. 23 March 2015
Pharmaceutical
The medicines cost watchdog the National Institute of Health and Care Excellence (NICE) has recommended Swiss pharma giant Novartis’ Xolair (omalizumab) as an option for add-on therapy for treating severe chronic spontaneous urticaria (CSU). 11 March 2015
Biotechnology
US biotech firm KYTHERA Biopharmaceuticals said yesterday that the US Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection. 10 March 2015
Pharmaceutical
The European Commission has granted Ireland-headquartered Actavis' subsidiary Durata Therapeutics International marketing authorization for Xydalba (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. 2 March 2015
Pharmaceutical
A Phase IIb study of dupilumab, from Sanofi and Regeneron, has shown that the drug improved patient-reported outcomes in moderate-to-severe atopic dermatitis. 23 February 2015
Generics
Ireland-headquartered generics major Actavis has entered an agreement with Mayne Pharma to divest the US rights to the Doryx (doxycycline) brand acne treatment and related assets. 10 February 2015
Biotechnology
Adding to recent marketing clearances in Japan and the European Union, the US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis. 22 January 2015
Biotechnology
The European Commission (EC) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. 19 January 2015
Biotechnology
US biotech firm Celgene’s European subsidiary has received marketing authorization from the European Commission (EC) for Otezla (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications. 18 January 2015
Pharmaceutical
Privately-held Spanish pharmaceutical company Ferrer says it has licensed commercialization rights for ozenoxacin 1% cream in Canada to local drugmaker Cipher Pharmaceuticals. 7 January 2015
Pharmaceutical
Independent Danish dermatology specialist Leo Pharma has submitted a New Drug Application to the US Food and Drug Administration for calcipotriene/betamethasone dipropionate aerosol foam 0,005%/0,064% for the treatment of psoriasis vulgaris. 6 January 2015
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