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 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
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. 19 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
The UK's National Institute for Health and Care Excellence (NICE) has decided not to recommend Xenpozyme (olipudase alfa) as a treatment for acid sphingomyelinase deficiency (ASMD; Niemann-Pick Disease) in people with type AB or type B. 5 March 2024
The Phase II KARDIA-2 study of zilebesiran, an investigational RNAi therapeutic in development for the treatment of hypertension (high blood pressure) - the leading cause of cardiovascular disease worldwide - met its primary endpoint. 5 March 2024
USA-based biopharma firm Paratek Pharmaceuticals has announced positive top-line efficacy data for Nuzyra (omadacycline) as post-exposure prophylaxis (PEP) in a non-human primate (NHP) model of inhalational anthrax. 5 March 2024
Danish diabetes and obesity specialist Novo Nordisk today announced positive headline results from the kidney outcomes trial FLOW, but its shares dipped 1.1% to 865 kroner. 5 March 2024
Beacon Therapeutics’ gene therapy AGTC-501 (laruparetigene zovaparvovec) is in the spotlight with encouraging interim results from SKYLINE trial in the retinitis pigmentosa (retinitis) market. 5 March 2024
All manufacturers participating in the first cycle of the US Medicare drug price negotiations have responded with counter offers, according to the US Department of Health and Human Services’ (HHS) Centers for Medicare and Medicaid Services (CMS). 5 March 2024
UK health technology assessor the National Institute for for Health and Care Excellence (NICE) today issued a final draft guidance recommending UK pharma major GSK’s Jemperli (dostarlimab) for a new indication. 5 March 2024
Announcing its financial results for 2023, diversified German drugmaker said it would delay a plan to break up the group for at least a couple of years. 5 March 2024
Danish CNS specialist Lundbeck will release clinical data from the AMULET Phase II, double-blind, randomized trial of Lu AF82422 in multiple system atrophy (MSA) at the InternaPional Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD 2024). 5 March 2024
The US Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADCs), replacing the February 2022 draft guidance. 5 March 2024
Californian cardiovascular specialist Bitterroot Bio has entered into a partnership with Biotheus, a Chinese company working on antibodies. 4 March 2024
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations on its diabetes med Farxiga (dapagliflozin). 4 March 2024
US clinical-stage biotech Akero Therapeutics’ shares soared 54% to $42.80 in pre-market activity today, after it released new data on its metabolic-associated steatohepatitis (MASH) candidate. 4 March 2024
California-based Gritstone bio, a biotech company aiming to develop the world’s most potent vaccines, has announced an approximately 40% reduction of its workforce. 4 March 2024