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
Following discussions with the US regulator, Texan drugmaker Lexicon Pharmaceuticals now plans to resubmit a New Drug Application (NDA) for sotagliflozin. 12 March 2024
New Zealander Guy Oliver has left his role as Ipsen’s general manager for the UK and Ireland, to take up the same position at Bristol Myers Squibb. 12 March 2024
US clinical-stage biotech IDRx today announced that it has strengthened its leadership team with the appointments of Tim Clackson, as chief executive and Brad Dahms as chief financial officer and chief business officer. 12 March 2024
Swiss drugmaker Basilea Pharmaceutica announced yesterday that the continued strong sales performance of the antifungal Cresemba (isavuconazole) by its license partner Pfizer in the Asia Pacific region and China exceeded the sales threshold triggering a $1.25 million milestone payment. 12 March 2024
Shares in San Diego, USA-based Acadia Pharmaceuticals fell around 20% ahead of the opening bell on Tuesday, following poor results from the ADVANCE-2 trial. 12 March 2024
USA-based Viatris said in a website posting that it has been informed by its partner, Israel-based Mapi Pharma, that it has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40mg from the US Food and Drug Administration (FDA). 12 March 2024
Danish firm Novo Nordisk has announced positive results from the kidney outcomes trial FLOW, in which Ozempic (semaglutide) 1mg reduced the risk of kidney disease progression and the risk of kidney and cardiovascular deaths by 24%. 12 March 2024
A final report for KarXT (xanomeline tartrate/trospium chloride) has been published by influential US pricing watchdog The Institute for Clinical and Economic Review (ICER). 12 March 2024
India's Department of Pharmaceuticals introduced the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme aimed at enhancing the technological prowess of the country's pharmaceutical sector to meet global standards. 12 March 2024
The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 12 March 2024
US immunology specialist Acelyrin came up with positive trial results for izokibep, which last year failed to meet a study endpoint for the treatment of moderate-to-severe hidradenitis suppurativa (HS). 12 March 2024
On Monday, the US Food and Drug Administration (FDA) issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. 12 March 2024
Shanghai-based CARsgen Therapeutics has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA). 11 March 2024
Eli Lilly has announced results from a Phase III study of lebrikizumab, an investigational therapy designed to treat atopic dermatitis in people with skin of color. 11 March 2024
German biosimilars company Formycon and Jordan-based MS Pharma have announced that FYB201, a biosimilar to Lucentis (ranibizumab), has received marketing authorization from the Saudi Food and Drug Authority. 11 March 2024
The ACTION3 Phase III trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomized patients, Melbourne, Australia-based Dimerix Limited revealed today. 11 March 2024