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
The Brazilian Ministry of Health backed Fiocruz foundation and non-profit organization Caring Cross have announced a collaboration to develop local manufacturing of chimeric antigen receptor (CAR)-T cell and stem cell gene therapies. 27 March 2024
Israel’s Teva Pharmaceutical Industries and Japanese drugmaker Daiichi Sankyo have been called out for breaches of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. 27 March 2024
Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical have secured European approval for a new formulation of Abilify Maintena (aripiprazole). 27 March 2024
UK pharma major AstraZeneca’s shares edged up 1% to 10,550 pence in early trading, as the company announced receipt of two approvals from the Japanese medicines regulator. 27 March 2024
The European Medicines Agency (EMA) has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. 27 March 2024
Veeda Clinical Research Limited, a full-service contract research organization (CRO) with a proven record of drug development success, announced that it has acquired Heads, a privately held European CRO, which specializes in conducting clinical trials in oncology. 27 March 2024
Not-for-profit research partnership TB Alliance has won a A$17 million grant from the Australian government to continue its work combating tuberculosis. 26 March 2024
US mRNA specialist Moderna this morning announced that mRNA1283, its next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase III clinical trial. 26 March 2024
Cohance Lifesciences and Suven Pharma are to merge, creating one of India's largest integrated contract development and manufacturing organization (CDMO) players. 26 March 2024
New York-based Nuvation Bio, a biopharma tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, is to buy AnHeart Therapeutics. 26 March 2024
US privately-held biopharma Pharmazz and Dr Reddy's Laboratories have enter into licensing agreement to market first-in-class centhaquine (trade name Lyfaquin) for hypovolemic shock in India. 26 March 2024
Japanese drug major Astellas Pharma today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Vyloy (zolbetuximab). 26 March 2024