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
Swiss pharma giant Roche today released new data from the Phase III OCARINA II study (S31.006) of Ocrevus (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. 17 April 2024
The Icelandic-Israeli pairing of Alvotech and Teva Pharmaceutical Industries have announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use. 17 April 2024
Ahead of a planned presentation at the American Thoracic Society meeting next month, US biotech major Amgen has released an update regarding the results of the Phase IIa COURSE trial for Tezspire (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), 17 April 2024
US privately-held Kumquat Biosciences today announced a strategic and exclusive collaboration with Japan’s Takeda to develop and commercialize a novel immuno-oncology (I-O) small molecule inhibitor as a mono- and/or combination-therapy. 17 April 2024
Novartis has announced data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta (ofatumumab) treatment for up to six years in recently diagnosed treatment-naïve people living with relapsing multiple sclerosis (RMS). 17 April 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older. 17 April 2024
Medicare beneficiaries in the USA are facing greater access restrictions on their lifesaving medicines, according to a study by the Schaeffer Center at the University of Southern California. 17 April 2024
A change of therapeutic focus, a full rebrand and a major cash injection will shake things up considerably at Massachusetts, USA-based Cullinan Therapeutics. 17 April 2024
North Carolina, USA-based KBI Biopharma has appointed Jean-Baptiste Agnus as chief business officer, joining the company’s executive team. 17 April 2024
The Russian government is considering designing additional measures aimed at creating conditions for the growth of domestic pharmaceutical market during the period of 2024-2025, reports The Pharma Letter’s local correspondent. 17 April 2024
France-based Medincell, a biopharma developing long-acting injectable drugs in many therapeutic areas, has announced a collaboration with US drugmaker AbbVie. 16 April 2024
US clinical-stage cell therapy developer Vittoria Biotherapeutics has announced that Keith Westby has joined the company as its inaugural chief operating officer (COO). 16 April 2024
German family-owned drugmaker Boehringer Ingelheim today announced a strong acceleration of its pipeline in 2023, as pivotal trials in key research areas progressed as planned, along with its full-year 2023 financial results. 16 April 2024
Having recently gained US regulatory approval for its Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), Swiss pharma giant Novartis is now arming itself with clinical data for a new indication. 16 April 2024