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
With the end of the year approaching, it is again time for The American Society of Hematology (ASH) Annual Meeting, the last major pharmaceutical conference in the calendar. 9 December 2023
The PrEPVacc HIV prevention study of experimental vaccine regimens and a new form of oral pre-exposure prophylaxis (PrEP) running in East and Southern Africa among 1,500 volunteer participants has stopped further vaccinations. 8 December 2023
Adding to its US regulatory clearance in August, the European Commission (EC) has now also granted conditional marketing authorization for Elrexfio (elranatamab), from US pharma giant Pfizer. 8 December 2023
British drugmaker AstraZeneca has published research in The Lancet outlining the impact of Fasenra (benralizumab) in severe eosinophilic asthma. 8 December 2023
Japanese drugmaker Daiichi Sankyo announced that its subsidiary Plexxikon and Swiss pharma giant Novartis have settled the patent infringement lawsuit against Novartis regarding the sale of the latter’s BRAF inhibitor Tafinlar (dabrafenib) in the USA. 8 December 2023
China’s National Medical Products Administration (NMPA) has approved the supplemental biologics license application (sBLA) for Cejemly (sugemalimab) alongside fluorouracil and platinum-based chemotherapy as a first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). 8 December 2023
US biotech Novavax has an advanced purchase agreement (APA) with the European Commission and an arrangement with the UK for the supply of the firm’s COVID-19 vaccine, developed with its Matrix-M adjuvant. 8 December 2023
Australian regulator the Therapeutic Goods Administration (TGA) says that its investigation into the risk of myocardial infarction and stroke in patients taking romosozumab (Evenity) found that stronger warnings regarding these risks were needed in the Product Information (PI) and Consumer Medicine (CMI) Information external sites. 8 December 2023
In the USA, the Biden administration announced a framework yesterday that proposes including prices as a factor when deciding if the public can easily obtain a taxpayer-funded drug and allowing government agencies to license the patent behind the product to another party if the cost is determined to be too high. 8 December 2023
German biotech BioNTech revealed that it has signed a multi-year strategic partnership with the State of Victoria in Australia to strengthen the local mRNA ecosystem and facilitate innovations deriving from it. 8 December 2023
Shorla Oncology, a privately-held, female founded US-Ireland pharmaceutical company, announced today that it has appointed Rayna Sethi Herman as chief commercial officer. 8 December 2023
Since the US Food and Drug Administration’s acceptance of Madrigal Pharmaceutical’s new drug application (NDA) and priority review for its THR-β agonist (resmetirom) in non-alcoholic steatohepatitis (NASH) in September 2023, the company has taken steps to fortify its leadership and financial position to gear up for the imminent launch of resmetirom. 7 December 2023
US hematology company Syros Pharmaceuticals has announced “strong and encouraging” initial data from its ongoing mid-stage trial, SELECT-AML-1. 7 December 2023
Netherlands-based Synaffix, which was recently acquired by Swiss contract development and manufacturing organization (CDMO Lonza, said today it has expanded its licensing agreement with China’s Innovent Biologics. 7 December 2023