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.
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
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
Japanese drugmaker Daiichi Sankyo has established two research institutes: DS Research Institute Boston and DS Research Institute Munich, in Cambridge, Massachusetts, USA and Munich, Germany, respectively. 23 May 2024
Cell engineering company MaxCyte has entered into a strategic platform license agreement with Legend Biotech, another company focused on cell therapies. 23 May 2024
Shares of UK immune-oncology company Roquefort Therapeutics rose almost 24% to 5.51 pence this morning, following the signing of a term sheet to out-license its Midkine antibody portfolio to Dubai-based PDC. 23 May 2024
SpyBiotech, a biotechnology company specializing in innovative vaccine platforms, has entered into a research agreement with the University of Oxford. 23 May 2024
A new cost-cutting campaign from New York-based Pfizer demonstrates the intensity of the firm’s focus on ensuring operational efficiencies. 23 May 2024
Japanese drugmaker Otsuka Pharmaceutical and its US subsidiary have decided to terminate the development of the novel compound AVP-786, which was being studied as a potential treatment for patients with agitation associated with dementia due to Alzheimer's disease. 23 May 2024
Biomarker-driven clinical research and development company Precision for Medicine has announced that Harpreet Singh has joined the Maryland firm as chief medical officer. 22 May 2024
US biotech major Biogen today revealed it plans to acquire privately-held Human Immunology Biosciences (HI-Bio), in a bid to expand its rare disease portfolio. 22 May 2024
Privately-held Swiss company Swixx Biopharma today announced a strategic acquisition of Biopas, one of Latin America’s leading marketing and distribution companies for international biopharmaceutical firms. 22 May 2024
The annual meeting of the American Society of Clinical Oncology (ASCO) is set to commence on 2 June in Chicago, with the highly anticipated plenary session taking place on the Sunday. 22 May 2024
Swiss generic and biosimilar medicines company Sandoz today announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe. 22 May 2024
UK pharma major GSK yesterday announced positive results from trials of depemokimab, an "ultra-long-acting biologic" that could simplify treatment options for patients with severe asthma. 22 May 2024
Rhythm Pharmaceuticals, a US biopharma specializing in rare neuroendocrine diseases, has announced that its drug Imcivree (setmelanotide) is expected to be funded and available for use in England and Wales within three months through the National Health Service (NHS) in specialist centers. 22 May 2024
Executives at cash-strapped biotech Lyra Therapeutics are hoping a drastic reduction in headcount will help keep the lights on, alongside other cost-cutting measures. 22 May 2024
The Russian government is considering tightening domestic patent legislation, in a move to respond to numerous calls of global drugmakers, which are unhappy with the level of protection of their original drugs in the local market, reports The Pharma Letter’s local correspondent. 22 May 2024
The Journal of Clinical Psychopharmacology has published a post hoc analysis of data from the Phase III KINECT-4 study of Ingrezza (valbenazine). 22 May 2024