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 in Californian rare disease company Reneo Pharmaceuticals have plummeted after the firm announced the failure of its pivotal STRIDE study. 15 December 2023
As a result of US President Biden’s much industry contested prescription drug law, the Inflation Reduction Act, drug companies will pay rebates to Medicare when prices of certain prescription drugs administered or dispensed to people with Medicare increase faster than the rate of inflation. 15 December 2023
Following a broadly positive advisory committee vote in October, the US Food and Drug Administration now approved US WorldMeds, Iwilfin (eflornithine). 15 December 2023
US life sciences venture capital firm Apple Tree Partners has announced $52 million in Series A funding for its portfolio company Deep Apple Therapeutics. 15 December 2023
Former Novartis executive James Bradner has joined Amgen as executive vice president of research and development (R&D), and chief scientific officer. 14 December 2023
Generics giant Teva Pharmaceutical Industries and fellow Israel-based artificial intelligence (AI) focused biotech Biolojic Design have signed a license agreement to develop a potential novel antibody-based therapy for the treatment of atopic dermatitis and asthma. 14 December 2023
USA-headquartered biotech CSL Behring, a subsidiary of Australia’s CSL Limited (ASX: CSL), has been granted Direct Access for Hemgenix (etranacogene dezaparvovec) by the French Ministry of Health, marking the first treatment to be authorized by this innovative process in France. 14 December 2023
US biotech companies Biogen and Sage Therapeutics have announced that Zurvuvae (zuranolone) is now available by prescription for the treatment of postpartum depression (PPD) for adults in the USA. 14 December 2023
Biotech major Amgen has announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for tarlatamab. 14 December 2023
The US subsidiary of South Korea-based Celltrion Healthcare has announced that Ventegra, a major US Medical Benefits Manager (MBM) who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model, will place an FDA-approved biosimilar to Roche’s Avastin (bevacizumab), Vegzelma (bevacizumab-adcd), on its commercial formulary as a preferred brand. 14 December 2023
The Global Health Innovative Technology (GHIT) Fund has announced an investment of approximately $8.8 million for the development of new drugs for malaria and Chagas disease. 14 December 2023
By 2032, the biosimilar medicines contribution to health systems access and sustainability will soon match the impact of generic medicines, says Medicines for Europe. 14 December 2023
The US Food and Drug Administration (FDA) yesterday announced the establishment of a new Genetic Metabolic Diseases Advisory Committee (GeMDAC) to help the agency explore the complex issues related to genetic metabolic disease drug development. 14 December 2023
Vertex Pharmaceuticals’ shares were up 9.2% at $390.42 mid-morning, after it announced positive results from its Phase II dose-ranging study of the non-opioid selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN). 13 December 2023
New York-based pharma giant Pfizer will finally be able to complete its $43 billion acquisition of Seagen, having addressed all of the concerns of antitrust regulators. 13 December 2023
Allergy Therapeutics saw its share jump more than 8% to 2.10 pence by early afternoon as it released new data on its allergy candidate. 13 December 2023
South Korea medicines regulator has issued guidelines to monitor the side effects of the two approved CAR-T therapies – Novartis’ Kymriah (tisagenlecleucel) and Johnson & Johnson subsidiary Janssen’ Carvykti (ciltacabtagene autoleucel). 13 December 2023