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
In what the company said was a big day for Monte Rosa Therapeutics, a clinical-stage biotech company developing novel molecular glue degrader (MGD)-based medicines, the company announced two major milestones. 17 October 2023
Chicago, USA-based artificial intelligence and antibody specialist SparX Biopharmaceutical is to embark on a new strategic collaboration with Arovella Therapeutics. 17 October 2023
Israeli drugmaker Teva Pharmaceutical Industries has announced that data from the UNITE study presented at the World Congress of Neurology in Montreal, Canada, show that Ajovy (fremanezumab) reduced migraine attacks and depression symptoms in migraine patients with major depressive disorder. 17 October 2023
Seattle, USA-based biotech Omeros Corporation saw its shares plummet as much as 58% to an all-time low of $0.92 yesterday, after it said it will discontinue development of an experimental therapy to treat a type of kidney disease after a late-stage study failure. 17 October 2023
Analysis of American prescribing trends made available by health tech pioneer DrFirst show a six-fold increase in prescriptions written for popular weight loss drug Wegovy (semaglutide) between December 2022 and June 2023. 17 October 2023
Swedish enzyme specialist Hansa Biopharma has announced results from an extended pooled analysis of the 17-HMedIdeS-14 study, testing the antibody-cleaving enzyme imlifidase. 17 October 2023
With pipeline approvals of varying mechanisms of action and an influx of newly diagnosed patients, the heart failure (HF) market is expected to grow at a compound annual growth rate (CAGR) of 5.2% from $31.9 billion in 2022 to $53 billion in 2032 across the seven major markets. 17 October 2023
Danish company Novo Nordisk has agreed to acquire ocedurenone - a drug in development for uncontrolled hypertension with potential application in cardiovascular and kidney disease - from Singapore biotech KBP Biosciences for up to $1.3 billion. 16 October 2023
If Ireland’s people were not already somewhat pessimistic on Monday following the country’s exit from the Rugby World Cup, they have further reason for gloom, according to the Irish Pharmaceutical Healthcare Association (IPHA). 16 October 2023
PHIOGEN Pharmaceuticals, an innovative biotech start-up housed in the Texas Medical Center Innovation Hub and pioneering next-generation bacteriophage-based therapeutics, has appointed Dr Mayukh Das as chief operations officer (COO). 16 October 2023
Interim Phase II data from the Phase II/III Orbit study demonstrate setrusumab resulted in 67% reduction in annualized fracture rate, as well as continuous and meaningful improvements in bone mineral density (BMD) in patients with osteogenesis imperfecta (OI). 16 October 2023
The Lonza subsidiary Synaffix, which is focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, has entered a licensing deal with SOTIO Biotech. 16 October 2023
Swiss biotech firm MoonLake Immunotherapeutics saw its US traded shares rise pre-market, after it announced positive 24-week top-line results from its global Phase II MIRA trial. 16 October 2023
Positive results from the Phase III SEQUENCE study show the benefit of AbbVie’s blockbuster biologic Skyrizi (risankizumab) in Crohn's disease. 16 October 2023
US pharma major Eli Lilly has released detailed results from the Phase III SURMOUNT-3 clinical trial evaluating tirzepatide in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. 16 October 2023