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
US biotech bluebird bio saw its shares close up almost 15% at $1.12 yesterday, after it reported first quarter 2024 results and business highlights, including recent commercial and operational progress. 10 May 2024
In a bid to retain its leadership position in the ever-expanding obesity sector, Novo Nordisk has inked another research collaboration, adding to a string of M&A and licensing deals over the past couple of years. 9 May 2024
Recent developments in the field of bispecific T-cell engagers (BiTEs) have led to the approval of three therapies for relapsed/recurrent multiple myeloma (RRMM). 9 May 2024
Companies including Gilead Sciences unit Kite, as well as Boston-based Treos Bio, have outlined data they intend to present at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO). 9 May 2024
Israel’s Teva Pharmaceutical Industries and France-based Medincell have announced results from the efficacy portion of the Phase III SOLARIS trial of olanzapine once-monthly long-acting injectable in schizophrenia compared to placebo. 9 May 2024
Japan's largest drugmaker Takeda Pharmaceutical today announced a restructuring, as annual profit for the fiscal year to March 31, 2024 slid by more than half following the loss of patent protection of major sellers. 9 May 2024
Israeli drugmaker Teva Pharmaceutical Industries missed estimates relating to earnings and exceeded expected revenue levels in presenting its first-quarter financial results. 9 May 2024
Accord BioPharma - the US specialty division of Intas Pharmaceuticals - has won US Food and Drug Administration (FDA) approval for Hercessi (trastuzumab-strf), a biosimilar to Roche’s (ROG: SIX) Herceptin (trastuzumab). 9 May 2024
On Wednesday, the American Heart Association (AHA)/American College of Cardiology (ACC) Joint Committee on Clinical Practice Guidelines issued a new clinical guideline for the evaluation and management of people with hypertrophic cardiomyopathy (HCM). 9 May 2024
2023 marked a significant upsurge in US Food and Drug Administration (FDA) approvals, particularly for ground-breaking treatments such as cell and gene therapies. 9 May 2024
Sino-American biotech BeiGene has announced results for the first quarter of 2024 and business highlights, sending it shares up 3% to 138.46 renminbi. 9 May 2024
New York-based biotech Regeneron Pharmaceuticals has announced highly encouraging results from a trial of its investigational gene therapy DB-OTO. 9 May 2024
The US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will review data supporting the new drug application (NDA) submitted by Lykos Therapeutics for midomafetamine (MDMA) capsules. 8 May 2024
Shares of USA-based tumor drug resistance specialist Deciphera Pharmaceuticals soared 73% to $25.34 in morning trading, on the news that it has received a takeover bid. 8 May 2024
Leading biotech incubator Flagship Pioneering has announced its latest investment, with the launch of a viral proteome start-up, Prologue Medicines. 8 May 2024