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
NeuroBo Pharmaceuticals (Nasdaq: NRBO), a clinical-stage biotechnology company focused on cardiometabolic diseases, has raised around $70 million through a private share placement. 26 June 2024
With pipeline approvals of varying mechanisms of action and an influx of newly diagnosed patients, the chronic kidney disease (CKD) market is expected to see significant expansion. 26 June 2024
Mixed results for AstraZeneca's (LSE: AZN) Imfinzi (durvalumab) have been reported, with success in bladder cancer and a late-stage miss in lung cancer. 26 June 2024
German pharma major Bayer’s BAY2927088 recently received the Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. 25 June 2024
US pharma major AstraZeneca (LSE: AZN) today revealed that its Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in Japan . 25 June 2024
This week we’re focusing on MASH. It’s a high area of unmet medical need, and while there are more than 80 therapies currently in the pipeline, only around 5% of these are in Phase III development. 25 June 2024
Russia will speed up the process of launching generics of original drugs that have been withdrawn from the market by their producers in a move to ensure better security of the country in its pharmaceutical sector, reports The Pharma Letter’s local correspondent. 25 June 2024
Swiss pharma giant Roche has announced that the European Commission has granted marketing authorization for Ocrevus (ocrelizumab) subcutaneous (SC) to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 25 June 2024
In a filing with the US Securities and Exchange Commission (SEC), Californian biotech Alumis has revealed it aims to raise around $300 million in its upcoming initial public offering (IPO). 25 June 2024
Danish diabetes and weight loss giant Novo Nordisk (NOV: N) has announced plans to invest $4.1 billion to build a second fill and finishing manufacturing facility in Clayton. 25 June 2024
Germany’s Merck KGaA (MRK: DE) has pulled the plug on its Phase III TrilynX study, evaluating xevinapant plus chemo in head and neck cancer. 25 June 2024
The US Food and Drug Administration (FDA) has approved Roche's PiaSky (crovalimab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 24 June 2024