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.
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
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Swedish Orphan Biovitrum has announced that the European Commission (EC) has approved an indication extension for Aspaveli (pegcetacoplan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who have hemolytic anemia. 8 May 2024
The top management of life sciences companies is very optimistic about 2024 and 2025, with over 80% of pharmaceutical, medical technology and biotechnology executives expecting profit growth for the current year and over 90% for the coming year. 8 May 2024
The US Food and Drug Administration (FDA) has now said it will convene an in person meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) on June 10, 2024, to discuss the Alzheimer's drug donanemab. 8 May 2024
India’s Bharat Biotech (BBIL) and Bilthoven Biologicals (BBio), the Dutch subsidiary of the Serum Institute of India, have inked a pact to manufacture oral polio vaccines (OPVs) in India. 8 May 2024
Half of pharma execs are bracing for significant revenue impact from Medicare price negotiations this year, compared to just 22% in 2023, according to research from revenue and compliance experts at Model N. 7 May 2024
US biopharma Vertex Pharmaceuticals remains an evergreen pick in the stock market, announcing another set of financial results that exceeded expectations. 7 May 2024
American inflammation and immunology (I&I) specialist Zenas BioPharma today announced the closing of an upsized $200 million Series C preferred stock financing. 7 May 2024
A trial flop for Massachusetts, USA-based EyePoint Pharmaceuticals has triggered a sell-off from investors, with the price of a share dropping by around half. 7 May 2024
Swiss generics and biosimilars drugmaker Sandoz today announced net sales for the first quarter 2024 of $2.5 billion, an increase of 6% in constant currencies compared to the same quarter of the prior year. 7 May 2024
Three of the world’s largest public health organizations are to join forces, backing a new research and development initiative with $300 million in funding. 7 May 2024
The first drug for the treatment of ankylosing spondylitis has been registered in the Russian Federation, according to the country’s Ministry of Health and local media reports. 7 May 2024