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 European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
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
China’s National Medical Products Administration (NMPA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. 10 January 2024
China-based Innovent Biologics has announced that the first Phase III clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with overweight or obesity (GLORY-1) met the primary endpoints and all key secondary endpoints. 10 January 2024
New York-based TG Therapeutics has entered into an agreement with Precision BioSciences related to an allogeneic CD19 CAR-T cell therapy. 10 January 2024
The novel type 2 oral polio vaccine (nOPV2), developed by a team including scientists from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has now been quality-assured (prequalified) by the World Health Organization (WHO). 10 January 2024
Blueprint Medicines Corporation has outlined its 2024 corporate strategy, promising accelerated revenue growth, sustainable research and development, and a clear path to profitability. 9 January 2024
The US Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Merck & Co’s sotatercept for pulmonary arterial hypertension (PAH). 9 January 2024
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval. 9 January 2024
A high-level committee, established to spearhead India's drive towards self-sufficiency in bulk drugs, has raised concerns about the substantial underutilization of allocated funds. 9 January 2024
UK pharma major GSK has entered into an agreement to acquire Anglo-American biotech Aiolos Bio, a clinical-stage company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions. 9 January 2024
Italian family-controlled drugmaker Chiesi Farmaceutici and Cambridge, USA-based Oak Hill Bio have executed a license and development agreement to develop, manufacture, and commercialize OHB-607. 9 January 2024
Japanese drugmaker Astellas has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for zolbetuximab. 9 January 2024
US pharma giant Merck & Co entered into a definitive agreement under which Merck, through a subsidiary, will acquire Harpoon Therapeutics for $23.00 per share. 9 January 2024
Breaking new ground, private Chinese start-up Argo Biopharmaceutical has won two exclusive license and collaboration contracts with Swiss cancer giant Novartis. 9 January 2024