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
US health technology assessor the Institute for Clinical and Economic Review (ICER) released a Final Evidence Report assessing the comparative clinical effectiveness and value of Novartis’ iptacopan and AstraZeneca subsidiary Alexion’s danicopan for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 14 March 2024
German antibody drug conjugate (ADC) specialist Tubulis has announced the successful completion of an upsized and oversubscribed 128 million euros ($138.8 million) Series B2 financing. 14 March 2024
The US Food and Drug Administration (FDA) has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC). 14 March 2024
Swedish exports of pharmaceuticals reached a peak of 152.2 billion kronor (~$15 billion), which corresponds to 7.3% of the country’s total export value, and means an almost 10% p increase since 2022. 14 March 2024
Once dubbed as me-too copycats and fast followers, Chinese biotechs are flocking to innovation mix, or combinatorial innovation, hoping to discover a novel therapy based on a mixture of existing resources, according to the consulting firm Clarivate. 13 March 2024
Two privately-held American firms, Allumiqs and Prolytix, have announced a long-term, strategic partnership focused on: “optimizing drug development pipelines.” 13 March 2024
Privately-held US biotech IFM Therapeutics today announced that Swiss pharma giant Novartis has exercised its option to acquire all of the outstanding capital stock of its subsidiary, IFM Due. 13 March 2024
In what the company describes as “a significant stride towards making advanced cancer treatment accessible to all,” Indian drugmaker Zydus Lifesciences (NYSE: ZYDUSLIFE) has launched olaparib, a PARP inhibitor marketed by UK pharma major AstraZeneca (LSE: AZN) as Lynparza, under the brand name Ibyra in India. 13 March 2024
Sweden-headquartered contract development and manufacturing organization (CDMO) Recipharm says that its ReciBioPharm unit has entered a collaboration agreement with GeneVentiv Therapeutics, a pre-clinical US gene therapy company 13 March 2024
The biopharmaceutical industry is witnessing a shift in investor sentiment. Despite facing challenges such as declining venture financing and macroeconomic pressures, there exists optimism about a recovery in biotech funding. 13 March 2024
Pfizer has won European Commission (EC) approval for Prevenar 20 for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in children aged from six weeks to less than 18 years. 13 March 2024
Swiss generics and biosimilars major Sandoz today announced strong financial results for the fourth quarter and full year ended December 31, 2023. 13 March 2024
Swiss drugmaker Roche - no doubt with the recent success of anti-amyloid candidates in mind - is persisting with its efforts in Alzheimer’s disease. 13 March 2024
Cambridge, USA-based synthetic biology company Pearl Bio, which is backed by Khosla Ventures, has entered a license, collaboration and option agreement with pharma giant Merck & Co, to discover biologic therapies comprising non-standard amino acids. 13 March 2024
US clinical stage biotech Coya Therapeutics’ shares closed down 7.7% at $9.01 yesterday, after it presented biomarker data as part of a panel presentation at the Society of Neuroimmune Pharmacology Conference. 13 March 2024