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
The US Food and Drug Administration (FDA) on Friday approved the supplemental Biologics License application (sBLA) for Elahere (mirvetuximab soravtansine-gyn) submitted by ImmunoGen, which was acquired by US pharma major AbbVie. 23 March 2024
At its March management board meeting, the European Medicines Agency adopted the EMA’s annual report for 2023, noting that, in 2023, Agency recommended 77 medicines for marketing authorization for human use, 39 of which had a new active substance, and adopted the EMA’s annual report for 2023. 23 March 2024
Oslo, Norway-based Photocure said today that it has received notice from medicines regulator Health Canada approving the product monograph for its Cysview (hexaminolevulinate hydrochloride). 22 March 2024
The Phase III KEYLYNK-006 trial evaluating Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with maintenance Lynparza (olaparib), a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic non-squamous non-small cell lung cancer (NSCLC). 22 March 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its March 2024 meeting. 22 March 2024
US clinical-stage company OKYO Pharma’s shares rose 5.7% to $1.86 pre-market today, as it announced additional key findings from analyses of the clinical data set from the 240 patient Phase II, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). 22 March 2024
Validating Novo Nordisk’s decision to research the cardiovascular impact of Wegovy (semaglutide), US authorities have said Medicare patients with heart problems can now receive the drug. 22 March 2024
Swiss rare disease specialist Relief Therapeutics today announced it has granted an exclusive license to Eton Pharmaceuticals or the commercialization of GOLIKE family of products in the USA. 22 March 2024
Japanese drugmaker Otsuka Pharmaceutical and the US unit of Denmark’s Lundbeck have presented new post hoc pooled analyses of two pivotal Phase III trials evaluating the safety and efficacy of Rexulti (brexpiprazole) in patients with agitation associated with dementia due to Alzheimer's disease. 22 March 2024
Yesterday, the US Food and Drug Administration (FDA) approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular dystrophy (DMD) in patients six years of age and older. 22 March 2024
The biobanking market - valued at $60.74 billion in 2022 - is forecast to grow at a CAGR of 5.68%, reaching a market size of $89.41 billion by 2029. 21 March 2024
Swiss pure-play dermatology category leader Galderma Group today announced the pricing of its Initial Public Offering (IPO) at 53 Swiss francs per share, at the top of the announced price range.
The shares will 21 March 2024
UK pharma major AstraZeneca today released results from the FLAURA2 Phase III trial that showed its Tagrisso (osimertinib) with the addition of chemotherapy provided a clinically-meaningful and consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). 21 March 2024
Capstan Therapeutics, a company advancing in vivo reprogramming of cells through RNA delivery using targeted lipid nanoparticles, has become the latest San Diego biotech to announce a major fundraising. 21 March 2024
Seelos Therapeutics, a company working on therapies for amyotrophic lateral sclerosis (ALS) and other central nervous system disorders (CNS) has been struck by a trial failure. 21 March 2024