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
Swiss specialty pharma Santhera Pharmaceuticals has announced that Agamree (vamorolone) has been approved in the UK for Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status. 12 January 2024
As generic competition has eroded sales of Fampyra (fampridine), US biotech major Biogen has decided to return its ex-USA rights to the multiple sclerosis treatment to licensor Acorda Therapeutics . 12 January 2024
US biopharma Emergent BioSolutions has secured a procurement contract with a maximum value up to $235.8 million to supply BioThrax (Anthrax Vaccine Adsorbed) for use by all branches of the US military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease. 12 January 2024
Shares of USA-based was Xeris Biopharma (were up 12% to $2.67 in morning trading yesterday, after it announced a licensing deal with biotech major Amgen. 12 January 2024
The US Food and Drug Administration (FDA) has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 (GLP-1) receptor agonists. 12 January 2024
China-based contract research, development and manufacturing organization (CRDMO) WuXi Biologics saw its shares jump nearly 9% to HK$30.45 by close of trading today, after it announced a new collaboration. 11 January 2024
The New Drug Application (NDA) for China-based Hutchmed’s sovleplenib as a treatment of adult patients with primary immune thrombocytopenia (ITP) has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA). 11 January 2024
Privately-held Spanish drugmaker Ferrer has reported that the Phase III ADORE trial of oral edaravone formulation (FAB122) in amyotrophic lateral sclerosis (ALS) did not meet primary or key secondary endpoints. 11 January 2024
Grifols, the Spanish producer of blood plasma-based products, is not taking the stock market damage done to the company by UK short seller Gotham City Research without a fight. 11 January 2024
China’s Shanghai Henlius Biotech today announced a strategic collaboration with USA-based Sermonix Pharmaceuticals for exclusive rights to develop, manufacture and commercialize Sermonix’ lead investigational drug, lasofoxifene, in China. 11 January 2024
A major equity investment will see Germany’s Bayer and New York-based life science investor RTW Investments take a stake in a Chinese biotech working on heart and eye conditions. 11 January 2024
The European Commission (EC) has granted conditional marketing authorization for Krazati (adagrasib), from US biotech Mirati Therapeutics. 11 January 2024
Coherus Biosciences has notified the US markets authority that it will terminate a collaboration with Shanghai-based Junshi Biosciences related to an anti-TIGIT candidate. 11 January 2024
Japanese drugmaker Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of its Alzheimer’s disease drug Leqembi (lecanemab) which is currently under review by the European Medicines Agency (EMA). 11 January 2024
Swiss-American eye specialist Alcon has announced positive topline results from two Phase III trials evaluating the efficacy and safety of AR-15512. 11 January 2024
Danish diabetes care giant Novo Nordisk has release top-line results from the COMBINE 3 Phase IIIa trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. 11 January 2024
US non-profit organization the Crohn’s & Colitis Foundation has joined forces with German biotech company Evotec, to help advance drug discovery for two innovative drug targets stemming from cutting-edge academic research for inflammatory bowel disease (IBD). 10 January 2024
Rob Scott has been appointed chief medical officer (CMO) of Abionyx Pharma, a French biotech focused on the discovery and development of innovative therapies based on the world's only recombinant apoA-I. 10 January 2024