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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
Novartis has presented new results from the Phase III ASTERIA I study showing omalizumab was effective and safe in the treatment of chronic spontaneous urticaria (CSU), a chronic and debilitating form of hives. 5 October 2013
Pharmaceutical
Astellas Pharma has announced positive topline data from the Phase III invasive aspergillosis study (SECURE) into isavuconazole, the antifungal agent being co-developed with Basilea Pharmaceutica. 30 September 2013
Pharmaceutical
Singapore is committing close to S$100 million ($79.6 million) to skin research, announced the Skin Research Institute of Singapore today. 27 September 2013
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma has announced the completion of a Phase III study to assess treatment with ingenol mebutate gel for actinic keratosis (AK). 26 September 2013
Pharmaceutical
US biotech firm KYTHERA Biopharmaceuticals (Nasdaq: KYTH) saw its stock upgraded to $50 a share from $34 by Leerink analysts and an outperform rating and $50 target by Cowen analysts, after the company said that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints. The shares rose 29% to $43.24 in pre-market trading today (September 17). 17 September 2013
Pharmaceutical
Luliconazole, a medication approved in Japan for the treatment of superficial mycosis in a 1% formulation, was not associated with any serious side effects when used in a 10% formulation to treat toenail fungus. 16 September 2013
Pharmaceutical
Under its collaboration with US pharma behemoth Pfizer (NYSE: PFE), Sweden's Karo Bio (STO: KARO) says it has made a significant achievement within the RORgamma project, triggering the first milestone payment (amount not disclosed) to Karo Bio. 6 September 2013
Pharmaceutical
USA-based Rigel Pharmaceuticals (Nasdaq: RIGL) today announced its plans to focus the company's resources on the completion of three lead clinical programs, a move which follows recent disappointing clinical results with the company's asthma drug candidate R343 (The Pharma Letter August 27). 5 September 2013
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb (NYSE: MBY) today (September 2) announced positive full results of the SAVOR clinical trial in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events. 2 September 2013
Biotechnology
Scotland-headquartered clinical-stage biotech firm NovaBiotics has entered into an exclusive agreement with a unit of USA-based Taro Pharmaceuticals Industries (NYSE: TARO) to licence and co-develop Novexatin, the company's first-in-class antifungal peptide treatment for fungal nail infections. Financial terms of the deal were not disclosed. 28 August 2013
Pharmaceutical
Switzerland-headquartered Galderma Laboratories says that the US Food and Drug Administration has approved Mirvaso (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. 27 August 2013
Biotechnology
Privately-held USA-based Ceptaris Therapeutics revealed yesterday (August 26) that the US Food and Drug Administration has granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. 26 August 2013
Biotechnology
Bangalore, India-based Biocon (BSE: 532523), Asia's premier biotechnology company, has launched its 'first in class' novel biologic ALZUMAb (itolizumab), the world's first anti-CD6 monoclonal antibody to be introduced for treating patients with chronic plaque psoriasis, in India. 13 August 2013
Pharmaceutical
Australian drugmaker Mayne Pharma (ASX: MYX) says it has signed two marketing and distribution agreements for Subacap, an improved formulation of itraconazole used to treat fungal infections, in four key European pharmaceutical markets. 12 August 2013
Pharmaceutical
The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) has recommended that the marketing authorizations of oral ketoconazole-containing medicines should be suspended throughout the European Union. 26 July 2013
Pharmaceutical
Canada's Nuvo Research (TSX: NRI) today (July 11) announced that its wholly owned subsidiary, ZARS Pharma, has entered into a license agreement for Galen US to acquire exclusive rights to market and sell Nuvo's Synera patch in the USA. 11 July 2013
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) has announced results from a Phase III psoriasis study which showed the superiority of its secukinumab (AIN457) in clearing skin compared to Enbrel (etanercept), which is made by US biotech leader Amgen's (Nasdaq: AMGN) and earned sales of $1.3 billion last year. 8 July 2013
Biotechnology
Pergamum, a portfolio company of Sweden-based investment company Karolinska Development, says that the primary safety and tolerability end-point was met in the randomized Phase I/II trial of human multifunctional peptide LL-37 for treatment of venous leg ulcers. 5 July 2013
Biotechnology
Swiss drug major Novartis' (NOVN: VX) generics unit Sandoz has initiated a major Phase III clinical trial with its biosimilar version of US biotech leader Amgen's Enbrel (etanercept), which last year generated worldwide sales of $4.23 billion for Amgen. 24 June 2013
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