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.
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
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Upstream Bio, a clinical-stage biotechnology company, has filed for an initial public offering, listing on the Nasdaq under the ticker symbol "UPB." 19 September 2024
Denmark-based Bavarian Nordic and Gavi, the Vaccine Alliance yesterday announced an advance purchase agreement (APA) to secure 500,000 doses of the MVA-BN mpox vaccine (marketed as Jynneos or Imvanex) to be supplied to countries in Africa impacted by the mpox outbreak. 19 September 2024
The atopic dermatitis (AD) market is on track to reach $16.7 billion across mature markets by 2030, according to data and analytics company GlobalData. 19 September 2024
TG Therapeutics yesterday shared new five-year data from the ULTIMATE I & II Phase III trials evaluating Briumvi (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
Swiss pharma giant Novartis today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU). 31 May 2024
The US Food and Drug Administration yesterday approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL). 31 May 2024
The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). 31 May 2024
Privately-held UK clinical-stage firm Soterios Pharma has announced positive multi-dose Phase II trial evaluating STS-01 as a treatment for mild/moderate alopecia areata (AA). 31 May 2024
Biogen has announced European approval for Qalsody (tofersen), for certain amyotrophic lateral sclerosis (ALS) patients, under exceptional circumstances. 31 May 2024
Danish allergy immunotherapy specialist ALK Abell today revealed that its European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities. 30 May 2024
Japan’s Nxera Pharma has expanded its strategic R&D partnership with UK-based computational biology company PrecisionLife into autoimmune disorders with the potential to identify new drug targets for the treatment of complex, chronic conditions. 30 May 2024
US genetic diseases and cancer drug developer BridgeBio Pharma has announced positive results of five new analyses of clinical endpoint events from its Phase III ATTRibute-CM study of acoramidis in transthyretin amyloidosis cardiomyopathy (ATTR-CM). 30 May 2024
The US Food and Drug Administration granted accelerated approval to Retevmo (selpercatinib) from US pharma major Eli Lilly for pediatric patients two years of age and older. 30 May 2024
Globally, the devastating and widespread impact of neurological disorders like Alzheimer's disease, epilepsy, Parkinson’s disease and depression is only getting worse. 30 May 2024
Bio-Thera Solutions has partnered with STADA Arzneimittel for the commercialization of BAT2506, a biosimilar candidate to Simponi (golimumab). 30 May 2024
Cell and gene therapy (CGT) manufacturing specialist Ori Biotech has introduced its IRO platform, aiming to streamline and scale the manufacturing process for CGTs. 30 May 2024
The US Food and Drug Administration has approved US biotech major Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. 30 May 2024
The US Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) submitted by Jazz Pharmaceuticals for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody. 30 May 2024
Johnson & Johnson has announced positive results from the Phase III MDD3001 trial for seltorexant, a selective orexin-2 receptor antagonist. 30 May 2024
New research published in Nature Communications shows another potential application for GLP-1 agonists, adding to established benefits in type 2 diabetes, obesity and heart disease. 30 May 2024