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
An Expert View from Danie du Plessis, executive vice president, pharmaceutical operations at Kyowa Kirin International, and chair of the Medical Affairs Professional Society (MAPS) board. 29 May 2024
Dublin, Ireland-headquartered protein specialist Prothena announced that US pharma major Bristol Myers Squibb has obtained the exclusive global license for PRX019. 29 May 2024
With the annual meeting of the American Society of Clinical Oncology (ASCO) now just days away, multiple large drugmakers have lifted the lid on data that they intend to present. 29 May 2024
Market and contract research organization IQVIA has published its Global Oncology Trends report for 2024, projecting a significant rise in cancer cases. 29 May 2024
The US Food and Drug Administration (FDA) has accepted the New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, under development by Swiss pharma giant Roche. 29 May 2024
Less than two years after it was launched, San Francisco-based start-up Cartography Biosciences has announced a deal with nearby biotech major, Gilead Sciences. 29 May 2024
US biotech Insmed (Nasdaq: INSM) yesterday released positive top-line results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase III trial to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. 29 May 2024
After more than 30 years with neuroscience-focused biopharma Neurocrine Biosciences, founder and chief executive Kevin Gorman is to retire in October - albeit staying on as a board member. 29 May 2024
Russia has suspended state purchases of a number of original anti-cancer drugs due to problems associated with sanctions and the ever-growing isolation of the country in the international arena, The Pharma Letter’s local correspondent reports. 29 May 2024
The Bill & Melinda Gates Medical Research Institute (Gates MRI) has appointed Patrice Matchaba, as chief executive (CEO), starting June 10, 2024. 29 May 2024
US healthcare giant Johnson & Johnson has acquired Yellow Jersey Therapeutics (YJT), a wholly-owned subsidiary of Swiss biotech Numab Therapeutics. 29 May 2024
Cambridge, USA-based Agios Pharmaceuticals closed up more than 23% at $38.81 yesterday, after it revealed it has agreed to sell its rights to its 15% royalty on potential US net sales of Servier’s vorasidenib to Royalty Pharma. 29 May 2024
Chief Executive Officers of the world’s largest generic and biosimilar medicines companies recently met in Vienna, Austria, to provide strategic advice to the International Generic and Biosimilar Medicines Association (IGBA). 29 May 2024
Sapreme, a Dutch biotech developing next-generation RNA therapeutics for genetically-driven diseases, has appointed Marco Timmers as chief executive. 28 May 2024
The European Commission today approved, under EU State aid rules, the first Important Project of Common European Interest (IPCEI) to support research, innovation and the first industrial deployment of healthcare products, as well as innovative production processes of pharmaceuticals. 28 May 2024
Shares of Swedish biotech Calliditas Therapeutics shot up more than 78% to 202.60 kronor by late afternoon, on news of a takeover bid from Asahi Kasei. 28 May 2024