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
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Germany’s Bayer has reported group revenue of 11.1 billion euros ($12.2 billion) in the second quarter of 2024, ahead of the 10.9 billion euros average of analysts’ estimates and up by 1% on the same period a year ago. 6 August 2024
Shanghai-based Antengene (SEHK: 6996) has announced that the Malaysian medicines regulator has approved Xpovio (selinexor) for the treatment of multiple myeloma. 6 August 2024
Actinium Pharmaceuticals’ shares closed down 60% yesterday and fell a further 10% to $2.23 in after-hours trading, when the company announced a regulatory setback for its Iead candidate. 6 August 2024
California’s BioMarin Pharmaceutical (Nasdaq: BMRN) has announced a strategic pivot for its Roctavian (valoctocogene roxaparvovec-rvox) business, focusing on the USA, Germany, and Italy. 6 August 2024
In Singapore, a division of Kyowa Kirin (TSE:4151), has announced plans to sell the firm’s Chinese business while reducing focus on small molecules, as part of a regional overhaul. 6 August 2024
Biotech incubators Two River and Third Rock Ventures have launched TRC 2004, a new company focusing on bispecific T-cell engagers (BiTE), according to a filing with the Hong Kong Stock Exchange. 6 August 2024
The Biosimilars Council—part of the USA’s Association for Accessible Medicine (AAM) representing companies developing off-patent medicines—has provided an update on its activities on the regulatory, legislative and educational fronts. 5 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
Agenus has revealed via a Securities and Exchange Commission (SEC) filing that US pharma major Bristol Myers Squibb (NYSE: BMS) was pulling out of a licensing deal. 5 August 2024
In common with many European countries, there are concerns in Switzerland that patients' access to some vital medicines is getting worse and worse. 5 August 2024
Shares of Genmab dipped 2.6% to 1,867 kroner in early trading, as the Danish drugmaker revealed that the return of rights to acasunlimab by German biotech BioNTech 5 August 2024
Taiwan-based Formosa Pharmaceuticals (6838.TWO) has announced an exclusive licensing agreement with Canadian pharmaceutical company Apotex for the commercialization of APP13007. 5 August 2024
Brussels-based UCB (OTCMKTS: UCBJF) has announced that it has received marketing authorization from the European Commission for two new 320 mg device presentations of Bimzelx (bimekizumab). 5 August 2024
Jade Biosciences (Nasdaq: JAD), a biotechnology company specializing in the development of therapies for autoimmune diseases, has announced the successful closing of an $80 million financing round. 5 August 2024