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 European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
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
Shares of US radiopharmaceuticals-focussed Lantheus Holdings (Nasdaq: LNTH) were down 5.4% at $51.88 by late morning today, as it announced the appointment of Brian Markison, current board chairman and industry veteran, to the position of chief executive (CEO), effective as of March 1, 2024. 23 January 2024
German pharma major Bayer’s independently operated company BlueRock Therapeutics today revealed it has exercised its option to exclusively license OpCT-001 under a 2021 deal with FUJIFILM Cellular Dynamics and Opsis Therapeutics. 23 January 2024
US genetic medicines developer GenEdit today revealed a multiyear collaboration and license agreement with Genentech as well as a $24 million Series A1 financing round. 23 January 2024
Small biotechs continue to show more interest in a public listing in 2024, with ArriVent Biopharma the latest to opt for an initial public offering (IPO) in the USA. 23 January 2024
Positive results in a Phase IIb trial could point the way to a breakthrough in non-alcoholic steatohepatitis (NASH) for West Coast-based biotech Sagimet Biosciences. 23 January 2024
French pharma major Sanofi has entered into a definitive agreement to acquire US biotech Inhibrx following the spin-off of non-INBRX-101 assets into ‘New Inhibrx’. 23 January 2024
Privately-held Danish dermatology specialist LEO Pharma says it has finalized the acquisition of the strategic asset TMB-001 as well as certain other assets from Timber Pharmaceuticals following the US firm’s Chapter 11 bankruptcy filing. 23 January 2024
Ionis Pharmaceuticals yesterday announced positive top-line results for the Phase III OASIS-HAE study of donidalorsen in people with hereditary angioedema (HAE), with the news sending the US RNA-targeted drug developer’s shares up more than 5% to $53.58. 23 January 2024
US biotech major Gilead Sciences is staring down the barrel of a 10% decline in its market value on Monday due to a setback with a key oncology asset. 22 January 2024
Oxford Nanopore Technologies, a UK company delivering nanopore-based molecular sensing technology, has announced the expansion of its leadership team. 22 January 2024
Despite an initial 3.4% dip, shares of Swiss clinical-stage biotech AC Immune were unchanged by early afternoon, despite announcing that a major licensing partner has pulled out of their deal. 22 January 2024
French clinical-stage biotech Abivax , which recently completed an around $236 million financing, saw its shares edge up 2.2% to 10.48 euros today, after the company provided an outlook on its 2024 strategic priorities and milestones. 22 January 2024