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
Shares of Switzerland-based clinical-stage drug developer Pharvaris rose by as much as 42% Wednesday morning, as it announced positive top-line data from the CHAPTER-1 Phase II clinical study meeting its primary endpoint, with deucrictibant. 7 December 2023
After eight years of follow-up, Eli Lilly has revealed that a statistically -significant overall survival (OS) improvement was not reached for patients in the MONARCH 3 trial. 7 December 2023
At an investor R&D day in New York, French drugmaker Sanofi provided an update on developments regarding its pipeline and what it expects to be key growth drivers in the future. 7 December 2023
Shares of Cerevel Therapeutics shot up almost 16% to $42.75 in pre-market trading this morning, after it was revealed late yesterday it had received a takeover offer from US pharma major AbbVie. 7 December 2023
South Africa's largest drugmaker Aspen Pharmacare has announced an agreement with newly-independent generics drugmaker Sandoz, related to its Chinese business. 7 December 2023
The US Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis. 7 December 2023
In a major crackdown, the US Food and Drug Administration (FDA) has been conducting an increased number of inspections of pharmaceutical manufacturing facilities in India. 7 December 2023
Ireland and USA-based natural killer (NK) cell therapy biotech ONK Therapeutics and US firm NAYA Biosciences have entered into a research partnership to evaluate combination therapy consisting of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK bispecific antibodies. 6 December 2023
Massachusetts, USA-based cell therapy specialist Abcuro today announced the appointment of Mark Pruzanski as chairman of its board of directors. 6 December 2023
The US Food and Drug Administration (FDA) has approved Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 6 December 2023
Swiss pharma giant Novartis is consolidating its commitment to radioligand therapies with the establishment of a second production site in China. 6 December 2023
Aqemia, a next-gen French pharmatech company leveraging artificial intelligence and quantum physics, has entered into a multi-year research collaboration with French pharma major Sanofi. 6 December 2023
American healthcare giant Johnson & Johnson has undertaken an in-depth business review, publishing plans which include the launch of 20 new products by the end of the decade. 6 December 2023
Neurocrine Biosciences yesterday revealed it has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for crinecerfont in congenital adrenal hyperplasia. 6 December 2023
Israel-based Teva Pharmaceutical Industries presented post hoc analysis of two Phase III studies at the European Headache Congress, showing the effectiveness of its already marketed migraine prevention treatment Ajovy (fremanezumab) in reducing migraine attacks in patients with migraine and co-morbid obesity. 6 December 2023
French drugmaker Sanofi is experiencing serious problems in Russia, as due to logistical problems, the company almost stopped exporting insulin from its Russian plant to the European Union. 6 December 2023
Germany-based Thermosome, a drug development company specializing in targeted tumor therapies, has named Frank Hermann as chief medical officer (CMO). 5 December 2023
Specialty biopharma firm Emergent BioSolutions has been awarded a $75 million option under an existing agreement with the Biomedical Advanced Research and Development Authority (BARDA). 5 December 2023