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Pharmaceutical
Privately-held dermatology specialist LEO Pharma today announced that Dr Christian Antoni has been appointed as senior vice president for global development at the Danish firm as of June 1, 2018. 29 May 2018
Biotechnology
Belgian drugmaker UCB has entered the field of immuno-dermatology with the US Food and Drug Administration’s (FDA) approval of a label expansion for the blockbuster inflammatory diseases drug Cimzia (certolizumab pegol). 29 May 2018
Biosimilars
Indian pharma major Lupin has submitted its first filing for a biosimilar product in the European Union (EU). 25 May 2018
Biotechnology
A pivotal Phase III trial evaluating Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (aged 12-17) met its primary and key secondary endpoints. 16 May 2018
Pharmaceutical
Shares in Almirall closed 4% up on Monday at 10.60 euros after Spain’s biggest drugmaker revealed its quarterly results. 14 May 2018
Generics
Switzerland’s Novartis is moving to offload its American dermatology business and oral treatments division, among other assets, for up to $2 billion. 14 May 2018
Biotechnology
Approval of risankizumab would further strengthen AbbVie's position in psoriasis market, says report
If European approval is granted for AbbVie’s risankizumab for moderate-to-severe plaque psoriasis, the company could further strengthen its position in the psoriasis market, a new report has suggested 11 May 2018
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending that Tremfya (guselkumab) be provided on the UK’s National Health Service (NHS) for patients with moderate to severe plaque psoriasis. 2 May 2018
Biotechnology
Data from Phase II and Phase I studies was enough for the US Food and Drug Administration (FDA) to accept for priority review the Biologics License Application (BLA) for cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC patients who are not candidates for surgery. 30 April 2018
Biotechnology
AbbVie has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis. 25 April 2018
Biotechnology
Research in the microbiome-targeted therapeutics has been in the news for some time, so the latest report from a leading data and analytics company is a timely look at some of the players. 19 April 2018
Biotechnology
Privately-held dermatology specialist LEO Pharma has made its first investment in microbiome technology. 12 April 2018
Biotechnology
Californian biotech Menlo Therapeutics is solely focused on the development of serlopitant, so it was perhaps not surprising that its failure in a Phase II trial caused the company’s share price to nosedive by 77% to $8.17 on Monday. 10 April 2018
Biosimilars
Though the cost of developing niche complex drugs and biosimilars is substantially high, the potential opportunity has got Indian drug majors in a frenzy, reports The Pharma Letter’s India correspondent. 10 April 2018
Pharmaceutical
The UK’s health technology assessor has issued draft guidance that does not recommend Dupixent (dupilumab) for routine use to treat moderate-to-severe atopic dermatitis, a condition which affects about 1.5 million adults in the country. 3 April 2018
Pharmaceutical
Dermavant has expanded not just its pipeline, but also its executive team, the dermatology specialist announced on Monday. 3 April 2018
Biotechnology
The US Food and Drug Administration has approved Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 21 March 2018
Biotechnology
Medicines regulator Health Canada granted its approval for Siliq (brodalumab) injection, for subcutaneous use, a monoclonal antibody that targets the interleukin (IL)-17 receptor for patients with moderate-to-severe plaque psoriasis. 14 March 2018
Pharmaceutical
There was bad news and good news on the research front last week, with a big disappointment for Dermira in a Phase III trial of its acne drug candidate olumacostat glasaretil. On the positive side, Clearside Biomedical’s came out with flying colors with its Phase III study of macular edema drug suprachoroidal CLS-TA, and a significant achievement for Esperion Therapeutics’ bempedoic acid. On the regulatory front, Theratechnologies gained US Food and Drug Approval for its HIV drug Trogarzo. And in the licensing arena there was a massive potentially worth $5.76 billion worldwide co-development and co-commercialization deal between Merck & Co and Japan’s Eisai its thyroid cancer Lenvima. Also attracting attention was Sanofi’s collaboration with Evotec on anti-infectives. 11 March 2018
Pharmaceutical
Xolair (omalizumab) came out unfavorably in a comparison with a new competitor in severe eosinophilic asthma in trial results presented on Monday, but news on Tuesday showed the Novartis (NOVN: VX) drug up in a more positive light. 6 March 2018
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
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