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Biotechnology
Newly-established Swiss biotech MoonLake Immunotherapeutics has in-licensed the tri-specific nanobody sonelokimab (M1095/ALX 0761) from Germany’s Merck KGaA (MRK: DE). 4 May 2021
Biotechnology
Complete response letters (CRLs) seem to be coming thick and fast from the US Food and Drug Administration, the latest victim being Denmark’s dermatology specialist LEO Pharma. 29 April 2021
Biosimilars
Boehringer Ingelheim as announced results from a Phase III, randomized study that concluded that switching several times from Humira (adalimumab) to Cyltezo (adalimumab-adbm) produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate-to-severe chronic plaque psoriasis. 24 April 2021
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human US (CHMP) recommended eight medicines for approval at its April 2021 meeting, five of which were novel drugs. 23 April 2021
Pharmaceutical
Issar Pharmaceuticals, the only company in India which focuses on research and development of New Chemical Entities (NCE), is licensing out its NCEs based on peptide technology, with pre-IND filing and US Patents, opening opportunities for fruitful partnerships. 21 April 2021
Biotechnology
There was good news today for Eli Lilly and Company (NYSE: LLY) and Incyte (Nasdaq: INCY) today, as they released positive results from a second Phase III trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2mg and 4mg in adults with severe alopecia areata (AA). 20 April 2021
Pharmaceutical
Fortress Biotech partner company Journey Medical today announced that it has entered into a definitive agreement to acquire Qbrexza (glycopyrronium) in the USA from Dermira, a wholly-owned subsidiary of Eli Lilly. 1 April 2021
Biosimilars
South Korea’s Samsung Bioepis says it is expanding its global footprint to Australia with the launch of Hadlima (adalimumab), a biosimilar referencing AbbVie’s (NYSE: ABBV) mega-billion drug Humira. 29 March 2021
Biotechnology
The US Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib) in the treatment of adult patients with active psoriatic arthritis. 17 March 2021
Biotechnology
Clarivate today announced the launch of its annual "Drugs to Watch" list, identifying drugs entering the market or launching key indications in 2021 which are predicted to achieve blockbuster status by 2025. 9 March 2021
Biotechnology
People in England and Wales who are living with moderate to severe atopic dermatitis (also known as atopic eczema) now have a new treatment option routinely available on the National Health Service (NHS). 3 March 2021
Pharmaceutical
The challenges faced by Spanish dermatology specialist Almirall during 2020 were laid bare as the company presented its annual financial results on Monday. 22 February 2021
Pharmaceutical
The US Food and Drug Administration has informed Ireland-incorporated specialty pharma firm Mallinckrodt that it is deferring action (pending a site inspection) on the Stratatech Biologics License Application (BLA) for StrataGraft, an investigational allogeneic cellularized scaffold product 19 February 2021
Pharmaceutical
Spanish dermatology firm Almirall has inked a deal with Denmark’s MC2 Therapeutics, gaining exclusive European rights to commercialize Wynzora (calcipotriene/betamethasone dipropionate) in plaque psoriasis. 17 February 2021
Pharmaceutical
The New England Journal of Medicine (NEJM) has published the results from the pivotal Phase III trials of Klisyri (tirbanibulin) ointment for actinic keratosis; the two double-blind, vehicle-controlled, randomized, parallel-group, multicenter, trials (KX01-AK-003 and KX01-AK-004). 11 February 2021
Biotechnology
Spanish dermatology specialist Almirall today announced the publication in the British Journal of Dermatology (BJD) of a full five-year pooled data analysis from two Phase III clinical studies, reSURFACE 1 and reSURFACE 2 of Ilumetri (tildrakizumab), an interleukin (IL)-23p19 inhibitor for the treatment of moderate-to-severe plaque psoriasis. 9 February 2021
Pharmaceutical
Spanish skincare specialist Almirall has appointed Gianfranco Nazzi as chief executive and executive director of the board of directors effective May 1, 2021. 8 February 2021
Biotechnology
Regeneron Pharmaceuticals' shares gained 3.9% in pre-market trading on Friday, after announced financial results for the fourth quarter and full year 2020. 6 February 2021
Biotechnology
Belgium’s largest drugmaker UCB today announced that The Lancet has published positive results from BE VIVID and BE READY, two Phase III studies evaluating the efficacy and safety profile of bimekizumab, its investigational interleukin (IL)-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe plaque psoriasis. 5 February 2021
Pharmaceutical
Swiss pharma giant Novartis was trading nearly 3% lower on Tuesday afternoon after presenting its financial results for the fourth quarter and 2020 as a whole. 26 January 2021
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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