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
Shares in Britain’s largest drugmaker, AstraZeneca, have surged to a multi-month high following better-than-expected financial results for the first quarter. 25 April 2024
Belgium’s largest drugmaker UCB today announced an update on its progress at its annual shareholder meeting (AGM), with the news edging its shares up 1.7% to 122.90 by midday. 25 April 2024
The UK’s second-largest drugmaker, GSK, expects to hear by the end of August whether the US regulator will expand the label for Jemperli (dostarlimab). 25 April 2024
Colombia’s government yesterday issued its first-ever compulsory license (CL) for use by the country’s Ministry of Health, to improve access to less-expensive generic versions of the key HIV medicine dolutegravir. 25 April 2024
The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 25 April 2024
On Wednesday, the US Food and Drug Administration (FDA) announced a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. 25 April 2024
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
In San Francisco, a new company focused on using artificial intelligence to power drug discovery has launched with more than $1 billion of committed capital. 24 April 2024
Swiss pharma giant Roche first-quarter 2024 sales figures this morning that were disappointing in some respects and saw the firm’s shares fall 3.5% to 221.70 francs. 24 April 2024
Norway-based clinical-stage immunologics company Calluna Pharma today announced the appointment of Margrethe Sørgaard to the position of senior vice president of clinical operations and pharmacovigilance. 24 April 2024
Swiss pharma giant Novartis and the product development partnership Medicines for Malaria Venture (MMV) have announced positive data from their Phase II/III CALINA study. 24 April 2024
Swedish biopharma Calliditas Therapeutics today announced positive global open-label extension (OLE) Phase III NefIgArd study results in IgA nephropathy (IgAN) patients treated with Nefecon/Tarpeyo (budesonide). 24 April 2024
The US Food and Drug Administration has approved Lutathera (lutetium Lu 177 dotatate, from Advanced Accelerator Applications USA, a Novartis company). 24 April 2024
UK pharma major AstraZeneca has appealed to the Russian Investigative Committee and the Federal Anti-Monopoly Service (FAS) against Russian drug firm Akrikhin, which produces a generic of the diabetes drug Forxiga (dapagliflozin) during the validity of the patent. 24 April 2024