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
Weaker-than-expected revenues from prostate cancer med Pluvicto (lutetium vipivotide tetraxetan) held back Swiss cancer giant Novartis in its latest financial results statement. 31 January 2024
Chicago, USA-based biotech COUR Pharmaceuticals has raised $105 million in a series A financing round, co-led by Lumira Ventures and Alpha Wave Ventures. 31 January 2024
US gene therapy company Avrobio and privately-held biotech Tectonic Therapeutic today announced that the companies have entered into a definitive merger agreement to combine in an all-stock transaction. 31 January 2024
US cell and gene therapy biotech 2seventy bio saw its share close up almost 15% at $4.01 yesterday, after it announced that it is transforming the company. 31 January 2024
Private company Defender Pharmaceuticals has had its submission for a new motion sickness treatment rejected by the US Food and Drug Administration. 31 January 2024
UK pharma major GSK today announced that its Omjjara (momelotinib) has now been granted Marketing Authorization (MA) in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA), following approval by the European Commission earlier this week. 31 January 2024
Japan has recently approved Dutch immunology specialist argenx’ (Euronext: ARGX) Vyvdura (efgartigimod alfa and hyaluronidase-qvfc) subcutaneous (SC) injection for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). 31 January 2024
A division of Indian generics drugmaker Glenmark Pharmaceuticals has agreed terms for a licensing deal with Chinese firms Alphamab Biopharmaceuticals and 3D Medicines. 30 January 2024
Vertex Pharmaceuticals today announced positive results from its Phase III program for the selective non-opioid selective NaV1.8 inhibitor V VX-548, in the treatment of moderate-to-severe acute pain. 30 January 2024
Indian drugmaker Orchid Pharma's antibiotic drug Exblifep (cefepime/enmetazobactam) has received approval from the European Medicines Agency (EMA), leading to a 20% surge in the company's stock. 30 January 2024
Danish biotech Ascendis Pharma today announced the formation and launch with Frazier Life Sciences of Eyconis Inc, a separate company created to develop, manufacture, and commercialize TransCon ophthalmology assets globally. 30 January 2024
Britain’s medicines regulator has approved a novel antibiotic developed by Cidara Therapeutics, a biotechnology company based in San Diego, California. 30 January 2024
US precision genetic medicines firm Sarepta Therapeutics has announced positive data from Part B of the MOMENTUM study (Study SRP-5051-201), a global, Phase II, multi-ascending dose clinical trial of SRP-5051 (vesleteplirsen) that enrolled patients aged eight to 21 years. 30 January 2024
Two Californian firms, Gilead Sciences and Arcus Biosciences, have doubled down on their commitment to developing new therapies using the TIGIT pathway. 30 January 2024
Enterprise Therapeutics, a UK biopharma dedicated to the discovery and development of novel therapies for respiratory disease, has closed a £26 million ($33.1 million) Series B follow-on financing round, led by Panakes Partners. 30 January 2024
Following on from its recent approval of Hyqvia (immune globulin) in Europe, Japanese pharma major Takeda has picked up a US approval for another CIDP product. 30 January 2024
Industry observers are cautiously hoping that early 2024 signs indicate that the post-pandemic biotech fundraising slowdown might be coming to an end. 30 January 2024
Iceland-based developer of biosimilar medicines, Alvotech has announced positive top-line results from a pharmacokinetic (PK) study for AVT03, a biosimilar candidate to US biotech major Amgen’s Prolia and Xgeva, with both having the active ingredient denosumab at different dosages. 30 January 2024