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.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
Danish drugmaker Novo Nordisk—a frontrunner in the obesity space with the GLP-1 receptor agonist Wegovy (semaglutide)—is now making swift progress in the field with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
Aligos Therapeutics (Nasdaq: ALGS) has announced positive top-line results from the Phase IIa HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. 20 September 2024
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
Japanese pharma company Nippon Shinyaku and privately-held UK small activating RNA (RNAa) therapeutics specialist MiNA Therapeutics have announced a collaboration. 5 April 2024
A near tripling in the stock price of Candel Therapeutics reflects a swing in investor confidence following mid-stage data from the firm’s lead immunotherapy program. 5 April 2024
Israel-headquartered drugmaker Teva Pharmaceutical Industries and Spain-based mAbxience have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. 5 April 2024
UK pharma major AstraZeneca today released positive high-level results of the ADRIATIC Phase III trial with its already blockbuster drug Imfinzi (durvalumab). 5 April 2024
In a filing with the US Securities and Exchange Commission (SEC), Canadian biotech Zymeworks has revealed the sudden replacement of its chief financial officer. 4 April 2024
Amylyx Pharmaceuticals’ shares were up 5.9% at $2.78 mid-morning, despite the company revealing that it was pulling its lead product from the market after the drug failed in a confirmatory trial that was announced last month. 4 April 2024
The UK’ Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Exblifep, the combined antibiotic cefepime/enmetazobactam. 4 April 2024
A second Expert View piece from Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex. 4 April 2024
The US Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection), developed by Swiss drugmaker Basilea Pharmaceutica. 4 April 2024
UCB's Bimzelx (bimekizumab-bkzx) has taken a step closer to a new US approval, with the regulator accepting a supplemental Biologics License Application in hidradenitis suppurativa (HS). 4 April 2024
Polish biotech company PolTREG has published new data on PD-1+ T-cells, outlining their usefulness as a biomarker for the efficacy of its candidate PTG-007. 4 April 2024
April is Fabry disease awareness month, which we are taking as an opportunity to explore advances in the pharmacological treatment of this rare disease. 4 April 2024
LENZ Therapeutics, a biopharma focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, is a step closer to realizing its ambition. 4 April 2024
First approved in 2009 as a treatment for schizophrenia, Vanda Pharmaceuticals’ Fanapt (iloperidone) has now won US regulatory approval for a new indication, with the news sending the US drugmaker’s shares up 33% to $5.23. 4 April 2024