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
Roche today released positive top-line results of the Phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. 19 September 2024
US contract development and manufacturing organization (CDMO) BioCentriq has appointed Syed Husain as its new chief executive (CEO), and as a member of the board of directors. 19 September 2024
Amgen has reported better-than-expected first quarter results, with simultaneous news from its obesity pipeline lifting the firm’s stock price by almost 15%. 3 May 2024
Philadelphia, USA-based Reunion Neuroscience, a company developing psychedelics for the treatment of mental health conditions, has announced the closing of a $103 million Series A financing. 3 May 2024
New Jersey, USA-based PDS Biotechnology today announced the appointment of Stephan Toutain, as chief operating officer (COO), effective as of May 1, 2024. 2 May 2024
The COVID-19 pandemic has underscored the vulnerabilities inherent in global supply chains, particularly those predicated on single-country reliance. 2 May 2024
Californian firm Daré Bioscience has completed a royalty monetization deal with XOMA, a company providing an alternative mechanism for biotechs to raise capital. 2 May 2024
San Diego, USA-based clinical-stage cell and gene therapy company Poseida Therapeutics saw its shares close up more than 20% at $2.92 yesterday, when it revealed a second collaboration with Japanese drug major Astellas Pharma. 2 May 2024
Sanofi’s Beyfortus (nirsevimab) reduced respiratory syncytial virus (RSV) hospitalizations by 82% in infants under six months of age, compared to babies who received no RSV intervention, according to the interim results of an ongoing study published in The Lancet. 2 May 2024
Danish diabetes giant Novo Nordisk today reported financial results for the first quarter of 2024, noting that sales increased by 22% in Danish kroner and by 24% at constant exchange rates to 65.3 billion kroner ($9.35 billion). 2 May 2024
New Zealand-based AFT Pharmaceuticals has announced the licensing of Maxigesic IV, the intravenous form of its proprietary pain relief medicine, for Brazil. 2 May 2024
Trade group the Association of the British Pharmaceutical Industry (ABPI) has published an executive summary of its consultation response to the government's proposed changes to the Statutory Scheme for branded medicines. 1 May 2024