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
The US Food and Drug Administration yesterday approved Japanese pharma major Takeda’s Adzynma (ADAMTS13, recombinant-krhn; TAK-755), adding to the approval a day earlier of the firm’s bowel cancer drug Fruzaqla (fruquintinib). 10 November 2023
Belgium’s largest pharma company, UCB, has announced new long-term data from the Bimzelx (bimekizumab) Phase IIb study BE AGILE and its open label extension (OLE). 10 November 2023
Novo Nordisk, one of Denmark’s largest companies, is to invest around $6 billion in the expansion of manufacturing facilities in Kalundborg. 10 November 2023
Germany’s Bayer and Recursion Pharmaceuticals, a US techbio firm seeking to decode biology to industrialize drug discovery, have updated the focus of their research collaboration to precision oncology. 10 November 2023
The US Food and Drug Administration (FDA) has approved Ixchiq, French specialty vaccines developer Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus. 10 November 2023
UK oncology-focussed biotech ValiRx edged up 2.5% to 12.30 pence this morning, after it announced it has entered into an agreement with StingRay Bio to investigate a lead series of drug candidates for use in oncology. 10 November 2023
A Phase II failure for Californian cell therapy company Atara Biotherapeutics has prompted a share sell-off, with the company’s stock falling 80% in value on Thursday. 10 November 2023
Cells are the basic unit of life and are themselves living. They coordinate, construct, kill, and multiply. Using human cells as medicines is as intuitively thrilling as it is technically difficult. 9 November 2023
Indian biotech firm Biocon says that its subsidiary, Biocon Biologics, has inked a deal with Eris Lifesciences which will see it divest its dermatology and nephrology branded formulations business unit in India that is mostly comprised of its legacy small-molecule brands. 9 November 2023
WuXi XDC has published a prospectus for its upcoming initial public offering (IPO), detailing plans to raise $470 million with a listing on the Hong Kong Stock Exchange. 9 November 2023
The UK's National Institute for Health and Care Excellence (NICE) has recommended Lamzede (velmanase alfa) in its final evaluation document as an option for treating the non-neurological signs and symptoms of mild to moderate alpha-mannosidosis in England and Wales. 9 November 2023
The market for myasthenia gravis (MG), an autoimmune and neuromuscular disease characterized by muscle weakness and fatigue, is set to experience a compound annual growth rate (CAGR) of 8.3% across the seven major markets. 9 November 2023
German pharma, science and technology company Merck KGaA today confirmed its forecast for fiscal 2023 despite a difficult market environment in the third quarter. 9 November 2023
China-headquartered Eccogene has entered into an exclusive license agreement with AstraZeneca under which the UK pharma major will develop and commercialize Eccogene's small molecule GLP-1 receptor agonist (GLP-1RA) ECC5004 for the potential treatment of obesity, type-2 diabetes and other comorbidities. 9 November 2023
Britain’s biggest drugmaker AstraZeneca has exceeded revenues expectations handily in the third quarter 2023, with robust demand in oncology leading the way. 9 November 2023
The US Food and Drug Administration late yesterday approved US pharma major Eli Lilly’s Zepbound (tirzepatide) injection for chronic weight management in adults with obesity. 9 November 2023