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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
Biotechnology
Oral Janus kinase (JAK) inhibitor Rinvoq (upadacitinib) 15mg and 30mg, once daily monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase III study in individuals with moderate to severe atopic dermatitis. 22 July 2020
Biotechnology
Privately held Danish drugmakers Union Therapeutics and LEO Pharma have completed a transaction for the former to acquire the global rights to the LEO PDE4 inhibitor compound series to be re-named UNI500. 21 July 2020
Pharmaceutical
Swiss pharma giant Novartis was trading 1.5% lower on Tuesday lunchtime after presenting its financial results for the second quarter of 2020. 21 July 2020
Biotechnology
Eli Lilly today announced that its mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of interleukin (IL)23, met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study. 17 July 2020
Biotechnology
Johnson & Johnson’s Janssen unit has announced that the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA). 14 July 2020
Generics
Novartis’ Sandoz unit has launched daptomycin for injection 500mg, an AP-rated generic version of Merck & Co’s Cubicin. 14 July 2020
Generics
Amid the ever-tightening competition in the Russian pharmaceutical market, global drugmakers continue to cut their local range as part of efforts for optimization of local business, reports The Pharma Letter’s local correspondent. 14 July 2020
Pharmaceutical
Endo International has been granted US Food and Drug Administration approval for Qwo (collagenase clostridium histolyticum-aaes), a treatment for cellulite. 7 July 2020
Biotechnology
Belgian biotech BCI Pharma has appointed Didier Malherbe as chairman of the board of directors. 6 July 2020
Pharmaceutical
Privately-held Danish medical dermatology specialist LEO Pharma today announced that Dr Monica Shaw and Nathalie Joannes will join the executive leadership team adding seasoned experience and international profile to the company. 1 July 2020
Pharmaceutical
French drugmaker Sanofi has certainly been on a public relations drive this year, using every chance possible to show off the progress of its pipeline and its investments in innovation and manufacturing. 24 June 2020
Biotechnology
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 19 June 2020
Biotechnology
Chicago-based AbbVie has released positive data from the Phase III MEASURE UP 1 study of Rinvoq (upadacitinib) in moderate to severe atopic dermatitis. 18 June 2020
Biotechnology
Janssen has announced new long-term plaque psoriasis data for Tremfya (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years) in adult patients with moderate to severe plaque psoriasis. 15 June 2020
Biotechnology
The European Medicines Agency has validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) under development by privately-held Danish dermatology specialist LEO Pharma. 12 June 2020
Generics
51 states and territories in the USA have banded together to accuse 26 drugmakers of drug price fixing. 11 June 2020
Biotechnology
Danish dermatology specialist LEO Pharma has promised a plethora of data from Phase III trials in atopic dermatitis (AD) and psoriasis at this year’s American Academy of Dermatology (AAD) virtual meeting later this month. 2 June 2020
Biotechnology
Regeneron and Sanofi have presented new data on the PD-1 inhibitor Libtayo (cemiplimab-rwlc) from a pivotal Phase II trial in advanced cutaneous squamous cell carcinoma (CSCC), the deadliest non-melanoma skin cancer. 1 June 2020
Pharmaceutical
Spanish drugmaker Almirall has teamed up with the University Carlos III Madrid (UC3M) and the MEDINA Foundation, and they have launched a project to find new treatments for recessive dystrophic epidermolysis bullosa and other genetic diseases caused by nonsense mutations. 28 May 2020
Biotechnology
The US Food and Drug Administration has approved a label extension for Dupixent (dupilumab), to include treatment of children aged six to 11 with moderate-to-severe atopic dermatitis (AD). 27 May 2020
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