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.
US neuroscience company BioXcel Therapeutics has announced a new clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. 20 September 2024
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
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
A new subcutaneous version of the checkpoint blocker Opdivo (nivolumab) could be approved earlier than expected, after the US regulator brought forward the date for a decision. 22 May 2024
UK pharma major AstraZeneca’s Fasenra (benralizumab) recently received Food and Drug Administration (FDA) approval for severe asthma in children aged six to 11, specifically for the eosinophilic phenotype, in over 80 countries, including the USA, European Union, and Japan. 22 May 2024
Taking another step into the sector, US pharma major Eli Lilly has signed an agreement with Boston, USA-based biotech firm Aktis Oncology, to generate anticancer radiopharmaceuticals using the latter’s novel miniprotein technology platform. 21 May 2024
Data have been presented from the NOTUS Phase III study on the use of Dupixent (dupilumab) as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy and evidence of type 2 inflammation. 21 May 2024
Given that the USA’s House Committee on Oversight and Accountability held a markup meeting last week on the legislation, it is likely that the USA will pass the BIOSECURE Act (the Act) in December this year. 21 May 2024
Israeli dermatology company Sol-Gel Technologies has signed an agreement with Beimei Pharma for the commercialization of Twyneo (tretinoin/benzoyl peroxide) in China, Hong Kong, Macau, Taiwan and Israel. 21 May 2024
UK antibody-drug conjugate (ADC) company Pheon Therapeutics today announced the completion of a $120 million Series B financing to fund the development of its pipeline of differentiated ADCs. 21 May 2024
US healthcare giant Johnson & Johnson has announced that the Tremfya (guselkumab) QUASAR maintenance study in ulcerative colitis (UC) met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission. 21 May 2024
Massachusetts-USA-based biotech-Progentos Therapeutics has announced its launch and the closing of a $65 million Series A round of financing. 21 May 2024
While AstraZeneca’s chief executive Pascal Soriot has been proven right about many of his prior boasts on the company’s future success during his 12-year reign, his latest claim could be questioned even by his strongest supporters. 21 May 2024
The European Commission (EC) has decided not to adopt the European Medicines Agency’ human medicines committee CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna (ataluren) and has returned the opinion to the CHMP for re-evaluation. 21 May 2024
On Monday, the US Food and Drug Administration (FDA) approved Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy) as the first interchangeable biosimilars referencing Regeneron’s Eylea (aflibercept). 21 May 2024
The use of AI across all industries and sectors has been heralded as driving efficiency and accelerating innovation, with some experts even citing the technology as the biggest disruptor of our lifetime. 21 May 2024
Shares of Massachusetts, USA-based muscle specialist Dyne Therapeutics closed up almost 28% at $35.38 yesterday, after it released positive clinical data from its ongoing Phase I/II ACHIEVE trial of DYNE-101. 21 May 2024
Following a review of its strategic options, Swedish immunology company InDex Pharmaceuticals has opted for a reverse merger with Stockholm-based Flerie Invest. 21 May 2024
Swiss biotech Idorsia today announced changes to its executive committee (IEC) and will propose changes in membership of the board of directors at the upcoming annual general meeting of shareholders (AGM), to be held on June 13, 2024. 21 May 2024