Dermatologicals
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Pharmaceutical
Privately-held Danish company MC2 Therapeutics has acquired option rights from US dermatology firm Regranion to exclusively license the latter’s RGRN-305 for the treatment of all human diseases. 25 September 2023
Biotechnology
Belgian drugmaker UCB is not expecting a decision from the US Food and Drug Administration (FDA) any time soon on its Biologics License Application (BLA) for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis. 20 September 2023
Biotechnology
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Adtralza (tralokinumab) in a new pre-filled pen, developed by privately-held Danish dermatology specialist LEO Pharma. 20 September 2023
Biotechnology
The European Commission (EC) has become the third medicines regulator to grant marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. 19 September 2023
Biotechnology
Citing resource constraints for the decision, the US Food and Drug Administration (FDA) says requires additional time to complete the Priority Review of Iovance Biotherapies’ Biologics License Application (BLA) for lifileucel. 18 September 2023
Pharmaceutical
Following its September 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of six novel medicines. 15 September 2023
Biotechnology
US immunology specialist Acelyrin lost a whopping 54% of its stock market value on Tuesday. 13 September 2023
Biosimilars
Samsung Bioepis has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Johnson & Johnson subsidiary Janssen’s Stelara (ustekinumab). 11 September 2023
Biosimilars
Industry analyst GlobalData has released research suggesting that a new Humira (adalimumab) biosimilar can expect to reach over $800 million in sales by the end of the decade. 1 September 2023
Pharmaceutical
Privately-held Danish company MC2 Therapeutics today announced an agreement under which a Huadong Medicine unit has been granted exclusive rights in Greater China to develop and commercialize MC2’s drug, Wynzora Cream for the treatment of plaque psoriasis. 31 August 2023
Pharmaceutical
Today, the US Centers for Medicare & Medicaid Services (CMS) has for the first time selected 10 drugs for negotiation. Seniors paid $3.4 billion in out-of-pocket costs for these drugs in 2022, the CMS stated. 29 August 2023
Biosimilars
US pharmacy benefit manager (PBM) CVS Health today revealed it has set up a wholly-owned subsidiary, named Cordavis. 24 August 2023
Biotechnology
Japanese mid-size drugmaker Kyowa Kirin says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for partial change of approved indication of Lumicef (brodalumab [genetical recombination]) for the treatment of palmoplantar pustulosis (PPP) that respond inadequately to existing therapies. 24 August 2023
Biotechnology
Bristol Myers Squibb has been granted a new European approval for Opdivo (nivolumab) as a monotherapy in skin cancer. 23 August 2023
Pharmaceutical
US rare and orphan dermatologic diseases firm Timber Pharmaceuticals saw it shares almost double to $2.79 this morning, on the news of a takeover bid. 21 August 2023
Pharmaceutical
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Danish dermatology specialist LEO Pharma’s delgocitinib cream. 18 August 2023
Biotechnology
Positive data for a new kind of medicine, a BTK inhibitor developed by Novartis, could pave the way to improved treatment options for people with chronic spontaneous urticaria. 9 August 2023
Biosimilars
German companies Fresenius Kabi and Formycon have reached a settlement with US healthcare giant Johnson & Johnson for the USA, concerning FYB202, a proposed biosimilar to Stelara (ustekinumab). 8 August 2023
Biotechnology
Nektar Therapeutics’ shares closed up a massive 82.6% at $0.98 yesterday, after it revealed announced that efficacy data previously generated by former partner Eli Lilly for Rezpeg (rezpegaldesleukin) that were presented at the September 2022 EADV Congress were incorrectly calculated by Lilly. 8 August 2023
Biosimilars
South Korea’s Samsung Bioepis and USA-based Organon have announced the interchangeable result of its Humira (adalimumab) biosimilar, SB5, based on a recently conducted Phase IV study. 3 August 2023
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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