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
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
US ophthalmology specialist Ocular Therapeutix announced that Namrata Saroj has joined the Company on a full-time basis as chief business officer (CBO). Dr Saroj previously served as development strategy consultant to Ocular since February 2024. 14 November 2024
Digital therapeutics company GAIA has announced the signing of a licensing agreement for attexis with fellow German firm MEDICE Arzneimittel Pütter. 14 November 2024
New York-based Metsera, a biopharma developing medicines for obesity and metabolic diseases, has closed a $215 million Series B financing to further advance its portfolio of clinical-stage, nutrient-stimulated hormone (NuSH) analog peptides. 14 November 2024
Pharma major Bristol Myers Squibb and US biotech Cabaletta Bio are set to present promising Phase I data on CD19-directed CAR-T therapies for severe, refractory lupus at the American College of Rheumatology 2024. 14 November 2024
Life science investor Syncona has announced the launch of its newest portfolio company, Slingshot Therapeutics, through the Syncona Accelerator initiative. 14 November 2024
Adaptimmune Therapeutics reported promising data Wednesday from its pivotal Phase II trial of lete-cel in certain solid tumors with few effective treatments. 14 November 2024
Privately-held Flare Therapeutics, a US biotech targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, has entered into a strategic discovery collaboration with Swiss pharma giant Roche. 14 November 2024
Danish allergy immunotherapy specialist ALK Abello today posted financial results for the third quarter of 2024, which pleased investors. 14 November 2024
Shares of US genetic meds company MeiraGTx Holdings were up 7% at $7.12 in early trading after it announced important developments along with its third-quarter 2024 financials, reporting a $0.54 per share loss. 13 November 2024
Gilead Sciences has announced new data from its pivotal Phase III PURPOSE 2 trial providing further details on the efficacy, safety and tolerability of twice-yearly lenacapavir for HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. 13 November 2024
US biotech major Amgen closed 7% lower on Tuesday after investors questioned whether reductions in bone mineral density might be linked to the use of its investigational obesity candidate MariTide (maridebart cafraglutide, formerly AMG 133) in a Phase I trial. 13 November 2024
Japanese drugmaker Nippon Shinyaku and USA-based Atsena Therapeutics have entered into an exclusive license agreement for the commercialization of ATSN-101 in the USA and Japan for advancing Atsena’s first- in-class, investigational gene therapy ATSN-101 for Leber congenital amaurosis caused by biallelic mutations in GUCY2D (LCA1). 13 November 2024
Belgian drugmaker UCB and US biotech Biogen’s Phase III PHOENYCS GO trial results signal a pivotal development for systemic lupus erythematosus (SLE) treatment, as dapirolizumab pegol met its primary endpoint and demonstrated enhanced disease control and safety at Week 48. 13 November 2024
Sino-American firm Insilico Medicine has shown the potential not just of its pipeline and lead candidate by presenting impressive Phase IIa data this week, but also of its in-silico drug discovery model and the wider artificial intelligence (AI) field. 13 November 2024
Anglo-American biotech Apollo Therapeutics and China-based Sunshine Lake Pharma have signed an exclusive license agreement to develop APL-18881, a bi-specific fusion protein aimed at treating metabolic diseases. 13 November 2024
Dutch firm Argenx and China’s Zai Lab have received an approval from the National Medical Products Administration (NMPA) for Vyvgart Hytrulo (efgartigimod alfa). 13 November 2024
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Although it is seeing a downturn in sales and profits, German biotech BioNTech is continuing to acquire assets with the cash pile it made through the covid pandemic, notably iis Comirnaty vaccine that was developed with Pfizer (NYSE: PFE). 13 November 2024
The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three biosimilars for approval at its March 2025 meeting. 28 March 2025
Cardiovascular-focused Milestone Pharmaceuticals was trading more than 60% lower early in trading on Friday, with its share price worth less than $0.90. 28 March 2025
Danish pharma major Novo Nordisk has taken another step in its strategy to maintain dominance in the obesity space by adding complementary mechanisms to pair with its blockbuster bGLP-1 franchise. 28 March 2025
Japan’s Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) to treat chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. 28 March 2025
German life sciences and pharma company Merck KGaA today revealed it has exercised its option with China’s Abbisko Therapeutics for commercialization of pimicotinib in the US and rest of world. 28 March 2025
Singaporean biotech Shanton Pharma has reported positive top-line results from a Phase IIb clinical trial of its investigational gout therapy SAP-001 in patients with refractory disease, a group that often fails to respond to existing oral treatments. 28 March 2025
US genomics firm Galatea Bio has raised $25 million in funding to expand its global biobank and accelerate the development of AI-powered tools for drug discovery and disease risk prediction, with a particular focus on populations historically left out of genomic research. 28 March 2025
The interleukin-2 (IL-2) therapies market in the USA is poised for major growth, projected to reach $4 billion by 2034, according to research from DelveInsight. 28 March 2025
Italian biopharma Chiesi Group has announced a major investment in Nerviano, near Milan, with the building of a new facility for the production of its therapeutic solutions. 28 March 2025
Germany-headquartered CureVac late Thursday announced that the European Patent Office (EPO) has confirmed the validity of CureVac's European patent EP 3 708 668 B1 subject to amendments to specify the scope of protection. 28 March 2025
US pharma major Merck & Co has shared the first results from a late-stage trial of a subcutaneous version of its blockbuster immunotherapy Keytruda (pembrolizumab), with data presented Thursday at the European Lung Cancer Congress. 28 March 2025
US clinical stage biopharma Candel Therapeutics has announced final survival data from a Phase IIa clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment. 28 March 2025
German drugmaker Bayer has signed a global licensing agreement with China-based Puhe BioPharma, gaining exclusive rights to develop and commercialize an early-stage precision oncology therapy targeting MTAP-deleted tumors. 27 March 2025
Danish cancer specialist Genmab today announced that the Japanese Ministry of Health, Labor and Welfare has approved Tivdak (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. 27 March 2025
Cambridge, USA-based RNS specialist Wave Life Sciences has announced positive data from the Phase II FORWARD-53 trial of WVE-N531, which is an exon skipping oligonucleotide being investigated in boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping. 27 March 2025
Genetic diseases company BridgeBio Pharma has announced that the Japanese Ministry of Health, Labor and Welfare has approved acoramidis, under the brand name Beyonttra, for the treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). 27 March 2025
UK-based specialty pharma Kelso Pharma, which is backed by private equity investor Apposite Capital, announced that it has secured over £140 million ($180 million) of acquisition funding. 27 March 2025
US biotech Equillium reported Thursday that its lead drug candidate itolizumab failed to meet the main objective in a Phase III trial for patients with acute graft-versus-host disease, sending shares tumbling in pre-market trading. 27 March 2025