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
US pharma major AbbVie announced financial results for the first quarter of 2024, showing that worldwide net revenues were $12.310 billion, an increase of 0.7% on a reported basis, or 1.6% on an operational basis. 26 April 2024
Bristol Myers Squibb has agreed terms for a new CAR T cell therapy supply agreement worth up to $380 million in upfront and milestone payments. 26 April 2024
Swedish Orphan Biovitrum, a rare disease company also known as Sobi, is set to raise around 10 billion Swedish kroner ($920 million) in debt. 26 April 2024
The European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use. 26 April 2024
Privately-held Isotope Technologies Munich (ITM) is not just the radiopharmaceutical company that can do it all - from manufacturing and supplying medical radioisotopes to developing a broad precision oncology pipeline, including two Phase III studies. 26 April 2024
Swedish company Alligator Bioscience saw its shares dip as much as 4.5% to 0.88 kroner in erratic trading this morning , after it announced that Finland’s Orion Corporation has selected the lead bispecific antibodies from the companies’ second development program. 26 April 2024
British pharma major AstraZeneca has presented new data from the INFORM and COVIDRIVE real-world studies at the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases (ECCMID). 26 April 2024
US pharma major AbbVie on Thursday announced positive top-line results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase IIIb/IV study that evaluated the efficacy and safety of Rinvoq (upadacitinib). 26 April 2024
In a recent comment letter to US President Biden’s trade ambassador, Pharmaceutical Research and Manufacturers of America (PhRMA) encourages the Office of the US Trade Representative (USTR) to strengthen medical supply chains by negotiating meaningful trade agreements. 26 April 2024
US pharma giant Merck & Co raised and narrowed its forecasts for profit and sales for 2024 in presenting its first-quarter financial results. 25 April 2024
In its first quarter 2024 results statement, Bristol Myers Squibb beat expectations on revenues, which increased 5% to $11.9 billion, although it posted a loss per share of $5.89, due to charges from recently-closed deals. 25 April 2024
Regeneron Pharmaceuticals has entered a deal with privately held Mammoth Biosciences to research, develop and commercialize Crispr-based gene-editing therapies targeting multiple diseases. 25 April 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published its Final Draft Guidance (FDG) on a combination therapy from Swiss pharma giant Novartis. 25 April 2024