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
At its June meeting, the European Medicines Agency’s (EMA) pharmacovigilance committee, PRAC, came to the conclusion that patients treated with CAR T-cell medicines should be monitored life-long for secondary malignancies. 14 June 2024
Japanese drugmaker Takeda has signed an option agreement with China’s Ascentage Pharma to enter into an exclusive license agreement for olverembatinib. 14 June 2024
US immuno-dermatology specialist biotech Dermavant Sciences, a subsidiary of Roivant Sciences, has achieved positive Phase III trial results with Vtama (tapinarof), a nonsteroidal, topical AhR-modulating agent, in atopic dermatitis (AD). 14 June 2024
The US Food and Drug Administration (FDA) yesterday granted accelerated approval to Augtyro (repotrectinib), from Bristol Myers Squibb), for a new indication. 14 June 2024
Avidity Biosciences, a biopharmaceutical company specializing in RNA therapeutics, has announced a public share offering, with the goal of raising $400 million. 14 June 2024
Overall survival (OS) results from the Phase II MagnetisMM-3 study of Pfizer’s Elrexfio (elranatamab-bcmm) in patients with heavily pre-treated relapsed or refractory multiple myeloma (RRMM), demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in cohort A (n=123) of the pivotal single arm trial. 14 June 2024
The European Commission (EC) has accused privately-held API manufacturer Alchem International of breaching European Union antitrust rules by participating in a long-lasting cartel concerning an important pharmaceutical product. 14 June 2024
China’s Innovent Biologics recently presented Phase I study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer. 14 June 2024
Bladder cancer specialist UroGen Pharma saw its shares close up nearly 38% at $17.50 yesterday, after it shared positive trial results on its lead pipeline candidate UGN-102, an innovative formulation of mitomycin. 14 June 2024
Kite, a Gilead Sciences company, has unveiled new analyses for Yescarta (axicabtagene ciloleucel) in relapsed/refractory large B-cell lymphoma (LBCL). 14 June 2024
South Korea’s Samsung Bioepis today presented the post-hoc analysis of the Phase III clinical study results for Epysqli (SB12), a biosimilar to AstraZeneca’s Soliris (eculizumab), at the EHA Congress. 14 June 2024
First launched in 2022, US precision immunology company Santa Ana Bio yesterday emerged from stealth with $168 million in combined Series A and B funding. 14 June 2024
The market for amyotrophic lateral sclerosis (ALS) products across mature markets could reach $1.3 billion by 2029, up from $317 million in 2019, according to GlobalData. 13 June 2024
As the UK heads for a general election next month, the Association of the British Pharmaceutical Industry (ABPI) today assessed the Labour Party manifesto, having yesterday appraised the UK Conservative pledges. 13 June 2024
Alzheon, a clinical-stage biopharma company, has secured $100 million in a series E funding round led by Alerce Medical Technology Partners. 13 June 2024
Johnson & Johnson says it has “grave concern” for the availability of future innovative mental health treatments in England, following a decision by National Institute for Health and Care Excellence (NICE) to not re-appraise Spravato (esketamine nasal spray) for treatment-resistant depression in England 13 June 2024
US drugmaker AbbVie and China’s FutureGen Biopharmaceutical have announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of inflammatory bowel disease (IBD), currently in preclinical development. 13 June 2024
AstraZeneca’s Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration to improve glycemic control in children with type-2 diabetes (T2D). 13 June 2024