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
The US Food and Drug Administration (FDA) yesterday approved the new drug application (NDA) for Agamree (vamorolone) as a treatment of patients aged two years or more with Duchenne muscular dystrophy (DMD), that was submitted by Swiss drugmaker Santhera Pharmaceuticals. 27 October 2023
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis that was fully spun out on October 4, announced the issuance of two highly successful inaugural CHF bonds with gross proceeds of 750 million francs ($843 million). 27 October 2023
The European Union is currently reviewing its pharmaceutical legislation, and the latest IQVIA white paper “Assessing the biosimilar void” sheds light on the growing biological medicines market and the opportunity to improve equitable access with biosimilar medicines competition. 26 October 2023
Gene editing company Verve Therapeutics has been cleared by the US regulator to go ahead with what will be the first in-human base editing study in the country, 26 October 2023
Eisai and Biogen have announced the presentation of new data for their Alzheimer’s drug Leqembi (lecanemab-irmb) 100mg/mL injection for intravenous (IV) use. 26 October 2023
US pharma giant Merck & Co has opted to pull the plug on two mid-stage trials of Alzheimer’s disease candidate MK-1942, due to safety worries. 26 October 2023
US Pharma major Bristol Myers Squibb today reported results for the third quarter of 2023, which the company says reflect significant pipeline progress and advances in the portfolio renewal strategy. 26 October 2023
Privately-held Italian drugmaker Dompé has announced the appointment of Shannon Sullivan as is chief commercial officer (CCO), with immediate effect. 26 October 2023
Independent data monitors have recommended that French microbiome specialist MaaT Pharma continues its Phase III ARES study without modification. 26 October 2023
Danish diabetes care giant Novo Nordisk recently revealed that its FLOW trial, which studies Ozempic (semaglutide) in diabetic patients with chronic kidney disease (CKD), will come to a halt almost one year prior to the planned completion date, as interim results alone were sufficient in proving that the treatment was successful in treating kidney failure in this patient group. 26 October 2023
China’s National Medical Products Administration (NMPA) has approved ViiV Healthcare’s Vocabria (cabotegravir injection) used in combination with Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection. 26 October 2023
USA-based BioXcel Therapeutics on Wednesday revealed that an independent third-party review of the data from a site in its TRANQUILITY II Phase III trial showed "positive findings." 26 October 2023
UK-based Revolo Biotherapeutics, which is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, has announced top-line data from its allergen challenge mapping study. 25 October 2023
The US Centers for Disease Control and Prevention (CDC) is issuing an alert to provide options for clinicians to protect infants from respiratory syncytial virus (RSV) in the context of a limited supply of nirsevimab. 25 October 2023
Barcelona, Spain-based plasma-derived medicine specialist Grifols saw its shares close down more than 5% at 9.88 euros, despite announcing positive results for a potential Alzheimer’s vaccine candidate. 25 October 2023
Fibrocor Therapeutics, a privately-held Canadian developer of therapeutics to treat fibrosis, has named William Newsome III as president and chief executive and Piet Wigerinck as chief scientific advisor.
William Newsome III was one of the co-founders of Fibrocor when he was with German drug discovery firm Evotec (ETR: EVT) and he has remained closely involved with the company as a non-executive director since 2018. 25 October 2023
UK pharma major GSK (LSE: GSK) today announced positive preliminary results from its Phase III trial the immune response and safety of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 50 to 59. 25 October 2023
Boston, USA-based biotech Elektrofi has entered a multi-target research collaboration and license agreement with US pharma major Eli Lilly to develop next-generation medicines that can be delivered subcutaneously. 25 October 2023
Norway’s clinical-stage biopharmaceutical company Nykode Therapeutics today announced that its private placement has been successfully placed, raising around 505 million Norwegian kroner (~$45 million) in gross proceeds through the allocation of 29,549,400 new shares at a subscription price of 17.10 kroner per share. 25 October 2023