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
Just a month after winning its first US approval for sickle cell disease (SCD), Casgevy (exagamglogene autotemcel [exa-cel]) has won a second Food and Drug Administration (FDA) approval. 17 January 2024
California, USA-based biotech Allakos yesterday announced disappointing top-line data from its Phase II clinical trial in patients with atopic dermatitis (ATLAS) and from its Phase IIb clinical trial in patients with chronic spontaneous urticaria (MAVERICK). 17 January 2024
After first approving the drug in 2014 for the treatment of primary immunodeficiency (PI) in adults, the US Food and Drug Administration (FDA) has now approved a new indication for HyQvia [immune globulin Infusion 10% (Human) with recombinant human hyaluronidase]. 17 January 2024
Canada-headquartered Genevant Sciences, a privately-held company of the Roivant family, has announced a collaboration and non-exclusive license agreement with Massachusetts, USA-based Tome Biosciences. 17 January 2024
Shares of US clinical-stage biotech Aclaris Therapeutics shot up as much as 40% to $1.21 in early trading today, after it announced leadership changes and that it is undertaking a strategic review of its business. 16 January 2024
Switzerland-based Stalicla, a biopharma advancing precision medicine pipelines for neuropsychiatric and neurological disorders, has announced the successful completion of the first closing of its Series B financing round, securing $17.4 million. 16 January 2024
New York, USA-based rare neurological disease drug developer Neurogene has announced the appointment of Julie Jordan as its chief medical officer (CMO). 16 January 2024
The European Commission has granted marketing authorization for yet another indication for Swiss pharma giant Roche’s cancer drug Tecentriq SC (atezolizumab; subcutaneous). 16 January 2024
Switzerland’s medicines regulator, Swissmedic, has updated its guidance regarding the authorization of generic medicines with certain active pharmaceutical ingredients (API). 16 January 2024
The Indian government has urged the United States to enhance the frequency of inspections carried out by the US Food and Drug Administration (FDA) in India, aiming to boost pharmaceutical exports. 16 January 2024
In potentially the biggest pharma licensing deal ever, Japanese pharma major Daiichi Sankyo and US drug giant Merck & Co announced a collaboration in October. 16 January 2024
Food and healthcare company Orion Group has made a bold step to expand its biotech interests, buying around a quarter of LegoChem Biosciences (Kosdaq: 141080) for $420 million. 16 January 2024
German family-owned pharma major Boehringer Ingelheim has announced a further expansion and upgrade of its manufacturing plant in Koropi, Greece, where the pharmaceutical market is forecast to grow by 8.2%, from $7.5 billion in 2022 to $7.8 billion in 2023. 16 January 2024
French healthcare non-profit Médecins Sans Frontières (MSF) has called on European lawmakers to amend a proposed law which would result in an effective export ban. 16 January 2024
Vyacheslav Kokeladze, a well-known Russian businessman and pharmaceutical tycoon, is investing about 1.4 billion roubles ($20 million) in the establishment of one of the country’s largest production facilities for generic medicines. 16 January 2024
DISCO Pharmaceuticals, a specialist biotech unlocking the surfaceome of cancer cells at scale to identify new targets and develop first in class drugs, today emerges from stealth. 16 January 2024