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
OneChain Immunotherapeutics (OCI), a Spanish biotech focused on the development of CAR-T therapies for the treatment of oncologic diseases, has named Stefanos Theoharis as the company's new chief executive. 1 February 2024
Clinical-stage US pharma company Protagonist Therapeutics' shares rose 6% to $26.5O in early trading, on news of a licensing deal for its blood disorder candidate rusfertide. 1 February 2024
French pharma major Sanofi was trading 4% lower late Thursday after presenting its fourth quarter and full year 2023 financial results. 1 February 2024
A new cell and gene therapy initiative from the USA's White House will launch with an initial focus on treatments for sickle cell disease (SCD). 1 February 2024
In a bid to focus on growth and innovation, Israeli generics drugmaker Teva Pharmaceutical is to hive off its active pharmaceutical ingredient (API) business. 1 February 2024
US clinical-stage biotech Remix Therapeutics today announced the appointment of Dominic Reynolds, as its chief scientific officer (CSO). 1 February 2024
Privately-held Scotland-based EnteroBiotix has announced the appointments of Dr James Barnes as chief operating officer (COO) and Chris Lea as chief financial officer (CFO). 1 February 2024
US biotech company Novavax, a specialist in protein-based vaccines, has detailed its latest plans for job cuts to save funds for the cash-strapped company. 1 February 2024
Adaptimmune Therapeutics saw its shares leap almost 10% by close of trading Wednesday and a further 5.2% to $1.01 in after-hours trading as it announced a regulator development for its cell therapy. 1 February 2024
China-based Innovent Biologics recently made a significant breakthrough in obesity treatment with mazdutide, showcasing promising Phase III (GLORY-1) results. 1 February 2024
The UK’s health technology assessor the National Instituted for Health and Care excellence (NICE) has recommended Tepkinly (epcoritamab), from US pharma major AbbVie, as a treatment option for eligible adults with an aggressive and fast-growing blood cancer. 1 February 2024
The US Food and Drug Administration (FDA) yesterday released the Revised Biosimilar User Fee Amendment (BsUFA) Research Roadmap to provide updated information about the biosimilar regulatory science research pilot program research priorities. 1 February 2024
All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by January 31, 2025. 31 January 2024
UK health assessor the National Institute for Health and Care Excellence (NICE) has issued its Final Guidance in England and Wales recommending the use of Zynlonta (loncastuximab tesirine), from Swedish Orphan Biovitrum. 31 January 2024
Sandoz, the recent generic and biosimilar medicines spin out from Novartis , today announced the launch of Tyruko (natalizumab) in Germany from February 1. 31 January 2024
Danish diabetes care giant Novo Nordisk this morning released financial results for full year 2023, showing that sales increased by 31% in kroner and by 36% at constant exchange rates to 232.3 billion kroner ($33.9 billion) in 2023 31 January 2024
British drugmaker GSK has exceeded expectations in the fourth quarter, with chief executive Dame Emma Walmsley presenting an upbeat view of the company’s trajectory. 31 January 2024