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 clinical-stage biotech Zura Bio on Thursday announced the appointment of Robert Lisicki as chief executive (CEO), effective April 8, 2024. 29 March 2024
The US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) as a treatment of classic galactosemia by three months. 29 March 2024
Just as MDMA looked to be leading the charge of psychedelics and related compounds towards market for mental health conditions, a dose of jeopardy has been thrown into the mix. 28 March 2024
US biotech major Gilead Sciences today announced an exclusive license agreement with Xilio Therapeutics to develop and commercialize Xilio’s Phase I tumor-activated interleukin (IL)-12 program, XTX301. 28 March 2024
Cell therapy company Gamida Cell will be forced to go private after failing to find a partner for its cell therapy product Omisirge (omidubicel-onlv), which won US approval a year ago. 28 March 2024
The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. 28 March 2024
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older. 28 March 2024
Swedish biotech Oncopeptides yesterday announced a collaboration with Vector Pharma FZCO to commercialize its flagship drug Pepaxti (melphalan flufenamide in the Middle East and North Africa (MENA) region. 28 March 2024
Dutch contract development and manufacturing organization (CDMO) Intravacc and Primrose Bio, a private US biotech developing discovery and production systems for protein and nucleic acid medicines, have announced a strategic partnership. 28 March 2024
Shares of US mRNA specialist Moderna closed up 3.2% at $110.59 yesterday, on the news that fund manager Blackstone Life Sciences will provide up to $750 million to fund Moderna’s influenza (flu) program. 28 March 2024
US biotech bluebird bio revealed that it had made mistakes in previous financial statements in a filing with the US Securities and Exchange Commission. 27 March 2024
An attempt from the conservative Alliance for Hippocratic Medicine to ban mifepristone, a medicine used to induce an abortion, threatens to undermine confidence in the American regulatory regime. 27 March 2024
California, USA-based clinical-stage biopharmaceutical company 89bio saw its shares gain more than 2% to $11.44 today, after it announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with metabolic-associated steatohepatitis (MASH). 27 March 2024
A South Korean clinical stage biotech, Bridge Biotherapeutic), has entered into a research collaboration with the University of Colorado School of Medicine. 27 March 2024
USA-based Praxis Precision Medicines, a biopharma translating genetic insights into therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, closed 21% up after Tuesday’s trading. 27 March 2024
A South Korean company, AriBio, has announced the signing of exclusive marketing rights for its investigational Alzheimer’s disease drug, AR1001. 27 March 2024
In what is seen as an important win for Merck & Co, the US pharma giant late yesterday announced that the US Food and Drug Administration (FDA) has approved sotatercept-csrk injection (which will be marketed in the USA as Winrevair). 27 March 2024