19 September 2024 Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
Danish drugmaker Novo Nordisk—a frontrunner in the obesity space with the GLP-1 receptor agonist Wegovy (semaglutide)—is now making swift progress in the field with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
Aligos Therapeutics (Nasdaq: ALGS) has announced positive top-line results from the Phase IIa HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. 20 September 2024
US neuroscience company BioXcel Therapeutics has announced a new clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. 20 September 2024
Sanofi has announced encouraging results from its Phase III HERCULES trial of tolebrutinib in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS). 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024
Edgewise Therapeutics has announced promising top-line results for its candidate EDG-7500, aimed at treating hypertrophic cardiomyopathy (HCM). 20 September 2024
Achilles Therapeutics has announced it will discontinue its tumor-infiltrating lymphocyte (TIL)-based clonal neoantigen T cell (cNeT) program and shut down its Phase I/IIa CHIRON and THETIS trials. 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
US companies Incyte and Syndax Pharmaceuticals today announced results from the pivotal Phase II AGAVE-201 trial of Niktimvo (axatilimab-csfr), 19 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
The share of cheap drugs in the Russian pharmaceutical market is steadily declining, while in the last three years their overall range in the market has declined two-fold, reports The Pharma Letter’s local correspondent. 7 February 2024
The Russian drugmaker Axelpharm is demanding a compulsory license for an antitumor drug based on Bosulif (bosutinib), marketed by US pharma giant Pfizer, reports The Pharma Letter’s local correspondent. 6 February 2024
US healthcare giant Johnson & Johnson late Monday announced top-line results from the pivotal Phase III VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG), as well as the Phase II DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). 6 February 2024
US biopharma Vertex Pharmaceuticals has announced positive results from its once-daily vanzacaftor/tezacaftor/deutivacaftor program, the most comprehensive Phase III pivotal program ever conducted by the company for cystic fibrosis (CF). 6 February 2024
Another encouraging result in the growth area of antibody-drug conjugates (ADC) reveals a significant survival benefit for people with multiple myeloma. 6 February 2024
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics’ made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease with vaso-occlusive crisis. 6 February 2024
Swiss pharma giant Novartis late yesterday announced that it has entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys, a Germany-based biopharmaceutical company developing innovative medicines in oncology. 6 February 2024
Clinical-stage US biotech Acumen Pharmaceuticals has appointed James Doherty as president and chief development officer, effective February 1, 2024. 6 February 2024
US genetic medicines company 4D Molecular Therapeutics was trading more than 70% higher during Monday morning's opening exchanges in New York. 5 February 2024
American dermatology company Verrica Pharmaceuticals has filed a lawsuit against Canada’s Dormer Laboratories related to the active ingredient cantharidin. 5 February 2024
Denmark-based Novo Holdings has entered into a merger agreement to acquire US contract development and manufacturing organization (CDMO) Catalent. 5 February 2024
An Expert View from Ross Maclean, Precision Health Economics, Outcomes Research and Head of Medical Affairs,
Precision Value and Health, and the same company's Jon Bambalas, Senior Vice President Business Development, Products Senior Vice President Business Development. 5 February 2024
UK pharma major GSK’s Arexvy (respiratory syncytial virus vaccine, adjuvanted) is currently undergoing regulatory review with the potential of being approved in Europe for use in adults aged between 50 and 59 who are at an increased risk for respiratory syncytial virus (RSV) infection. 5 February 2024
Neuropsychologist Dr Paul Wicks joins the ranks of Cambridge, UK-based precision medicine scaleup Sano Genetics today, where he will take up the full-time role of vice president of neuroscience. 5 February 2024