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
MAIA Biotechnology, a US biopharmaceutical company developing targeted immunotherapies for cancer, has announced a positive update on its lead clinical candidate. 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
Trade association has called on the authorities of Russia to make adjustments for the methods of calculation of the initial maximum price of contracts (IMCP) for public procurements of drugs. 17 July 2024
The Phase III ARANOTE trial met its primary endpoint, significantly increasing radiological progression-free survival (rPFS) with darolutamide + androgen deprivation therapy (ADT) compared to placebo plus ADT, says Bayer. 17 July 2024
As the World Health Organization (WHO) calls for advancements to combat serious infections, one American firm is raising awareness about its work on nanoparticles. 17 July 2024
Relay Therapeutics in a Securities and Exchange Commission (SEC) filing that it has received notice of termination of the collaboration and license agreement with Genentech 17 July 2024
Tokyo-based Renalys Pharma, a late-stage clinical biopharmaceutical company, has successfully completed a $43.5 million series A financing. 17 July 2024
Lexicon Pharmaceuticals announced that the US Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista (sotagliflozin) 17 July 2024
Japanese firm Kissei Pharmaceutical (OTC: KSPHF) has announced promising results from two domestic Phase III trials of its GnRH receptor antagonist linzagolix. 17 July 2024
US health technology assessor the Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Ohtuvayre (ensifentrine). 17 July 2024
Swedish drugmaker Orexo (STO:ORX) has been struck by an unexpected delay in its bid to register a high-dose naloxone rescue medication in the USA. 17 July 2024
A licensing deal between CSL Vifor and Akebia Therapeutics has been terminated, as the commercial launch of Vafseo (vadadustat) gets underway. 16 July 2024
SOTIO Biotech, a Czech biopharma owned by PPF Group, and Biocytogen, a Chinese firm focused on the discovery of novel antibody therapeutics, have announced a research collaboration and exclusive option and license agreement. 16 July 2024
Cardurion Pharmaceuticals, which is developing next-generation therapeutics for the treatment of cardiovascular diseases, today announced a $260 million Series B financing. 16 July 2024
AbbVie’s market leadership, driven by its flagship disease-modifying antirheumatic drug Humira (adalimumab), faced a significant test with the 2023 loss of patent protection. 16 July 2024
Sionna Therapeutics today announced it has acquired exclusive worldwide rights to develop and commercialize multiple clinical-stage compounds through a license agreement with pharma major AbbVie. 16 July 2024