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
Germany’s Fresenius - via its operating company Fresenius Kabi - has announced the immediate US availability of Tyenne (tocilizumab-aazg), a biosimilar of Roche’s Actemra (tocilizumab). 16 April 2024
Japanese drugmaker Astellas expects to book an impairment charge of 70 billion yen ($453 million) in the fourth quarter of Japan’s 2023 fiscal year, which ended last month. 16 April 2024
US biotech Arrowhead Pharmaceuticals recently unveiled final data from its Phase II SHASTA-2 clinical trial for plozasiran, previously recognized as ARO-APOC3. 16 April 2024
USA-based rare seizure specialist Marinus Pharmaceuticals saw its shares crash, falling nearly 83% to $1.36, after it revealed that a trial failed to meet early stopping criteria. 16 April 2024
UK pharma major AstraZeneca has notched up another clinical success for its already blockbuster cancer drug Imfinzi (durvalumab) in biliary tract cancer. 16 April 2024
In a significant stride towards addressing the challenge of meningococcal-B disease, Serum Institute of India (SII) and the University of Oxford, UK, have formalized a technology license agreement negotiated by Oxford University Innovation. 16 April 2024
Italian family-owned drugmaker Chiesi Farmaceutici has appointed Richard Smith as vice president and business unit leader of the US AIR at Chiesi USA. 16 April 2024
Bulgaria’s Supreme Administrative Court has cancelled the mechanism guaranteeing the predictability and sustainability of the National Health Insurance Fund (NHIF) budget for drugs for 2021. 15 April 2024
US immuno-oncology company Portage Biotech has only around a fifth of its stock market value since early Friday, when the firm reported that it is expanding its evaluation of strategic alternatives and implementing additional measures to extend its cash runway. 15 April 2024
The Phase I trial of NMRA-266 has been placed on clinical hold by the US Food and Drug Administration (FDA), said the drug’s developer, Massachusetts, USA-based based brain disease biotech Neumora Therapeutics. 15 April 2024
A US judge has dismissed a legal claim from pharma major Eli Lilly alleging that an online pharmacy illegally sold an unauthorized compounded version of the company's dual GIP and GLP-1 receptor agonist tirzepatide. 15 April 2024
Japanese drugmaker Nxera Pharma has entered into an exclusive supply and distribution agreement with Handok to commercialize Pivlaz (clazosentan sodium) 150mg in South Korea. 15 April 2024
The US Centers for Medicare & Medicaid Services (CMS) has announced proposals to improve access to gene therapies that have recently been approved for use in the USA for the treatment of sickle cell disease (SCD). 15 April 2024
Roche’s CD20xCD3 T-cell engaging bispecific antibody Columvi (glofitamab) has met the primary endpoint of overall survival in relapsed or refractory diffuse large B-cell lymphoma in the Phase III STARGLO study. 15 April 2024
A new modelling analysis by UK pharma major AstraZeneca, IMPACT CKD, forecasts up to 16.5% of the population across eight countries will suffer from chronic kidney disease (CKD) by 2032, including a staggering rise of up to 59.3% in advanced-stage. 15 April 2024
The US Food and Drug Administration’s (FDA) oncology drugs advisory committee (ODAC) voted 12-0 to endorse the use of minimal residual disease (MRD) at 10-5 in complete responders (CR) as an intermediate endpoint for accelerated approval, potentially opening the door to new trial designs for blood cancer drugs. 15 April 2024