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
More data from the Phase III KEYNOTE-A18 study have been released, showing the potential for Merck & Co’s best-selling cancer drug to be used in earlier treatment settings. 15 March 2024
Danish CNS specialist Lundbeck today announced the advancement of the clinical development of for migraine prevention with the initiation of PROCEED, a randomized, double-blind, Phase IIb, dose-finding trial to assess efficacy and safety of multiple subcutaneously administered doses. 15 March 2024
Cartesian Therapeutics has revealed in a stock exchange filing that it has received notice from Japanese pharma major Astellas’ subsidiary Audentes Therapeutic that it is terminating their license and development agreement. 15 March 2024
More than a year later than expected, Sino-American oncology specialist BeiGene has finally secured US approval for its novel checkpoint inhibitor, tislelizumab-jsgr. 15 March 2024
German drugmaker STADA Arzneimittel announced financial results, noting that it has maintained its growth momentum in 2023 with double-digit sales and profit growth. 15 March 2024
The US Food and Drug Administration (FDA) yesterday approved Rezdiffra (resmetirom) for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). 15 March 2024
New York-based neuroscience company Gilgamesh Pharmaceuticals has been awarded a multi-year $14 million grant from the National Institute on Drug Abuse (NIDA). 14 March 2024
German firms Bayer and Aignostics have announced a strategic collaboration on several artificial intelligence (AI)-powered approaches with applications in precision oncology drug research and development. 14 March 2024
New research from industry analyst Research and Markets highlights the potential of the bispecific antibody market, indicating strong growth in the present period. 14 March 2024
US clinical-stage pharma company Spruse Biosciences announced disappointing top-line results from its CAHmelia-203 study of tildacerfont. 14 March 2024
New real-world data show a positive safety profile for Xcopri (cenobamate), an anti-seizure medication which is offered in a tablet formulation. 14 March 2024
US RNA-targeted drug developer Ionis Pharmaceuticals has announced positive results from a Phase II study of ION224, an investigational DGAT2 antisense inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). 14 March 2024
Politics has entered the scientific realm in the form of new US legislation that has prompted the Biotechnology Innovation Organization (BIO) to come into line with Congress’s position on Chinese companies. 14 March 2024
US biopharma company Catalyst Pharmaceuticals has announced the US commercial launch of Agamree (vamorolone) oral suspension for the treatment of Duchenne muscular dystrophy (DMD) in patients aged two years and older. 14 March 2024
Just a couple of months after launching its direct-to-consumer pharmacy service, Eli Lilly has announced plans to ramp things up significantly. 14 March 2024