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
Swiss pharma giant Roche saw its shares fall more than 5% to 254.60 francs this morning, after it posted a cautious forecast for full-year 2023. 19 October 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) late yesterday confirmed that pre-filled pens falsely labeled as the diabetes medicine Ozempic (semaglutide, 1mg, solution for injection) have been identified at two UK wholesalers. 19 October 2023
The life sciences sector contributed £43.3 billion ($52.6 billion) to the UK economy in 2021 through production of goods and services, with pharma manufacturing responsible for a majority of £19.2 billion. 19 October 2023
Elevar Therapeutics and Hengrui Pharma have agreed to a global licensing deal giving the former rights to commercialize and develop the checkpoint blocker camrelizumab. 18 October 2023
Sino-American biotech BeiGene became the first Chinese-origin pharma company to market a programmed cell death protein 1 (PD1) therapy for oncology indications in various global markets, beginning with the European Union. 18 October 2023
UCB has won two approvals from the US Food and Drug Administration, one for a new first-in-class rare disease med and another, for Bimzelx (bimekizumab-bkzx), bringing a new option for Americans with plaque psoriasis. 18 October 2023
Sanofi has presented new data from its Phase III program for Tzield (teplizumab-mzwv) at the 49th Annual ISPAD Conference, in The Netherlands. 18 October 2023
Shares USA-based clinical-stage biotech Evelo Biosciences plummeted 59% to $1.20 yesterday, as it announced disappointing top-line results from its Phase II clinical study with EDP2939 in moderate psoriasis. 18 October 2023
Japanese drugmaker Takeda has announced that the Phase III ADMIRE-CD II study of Alofisel (darvadstrocel) in complex Crohn’s perianal fistulas (CPF) failed to meet its primary endpoint of combined remission at 24 weeks, based on topline data. 18 October 2023
A firm in Massachusetts, USA, has won approval for a new kind of medicine, a phosphate absorption blocker, which will be used to treat certain people with chronic kidney disease (CKD). 18 October 2023
The US Food and Drug Administration (FDA) has approved US pharma giant Merck & Co’s leading checkpoint blocker Keytruda (pembrolizumab) for the treatment of patients with resectable non-small cell lung cancer (NSCLC). 18 October 2023
The first generic version of the popular drug for controlling glucose levels, Ozempic (semaglutide), which is produced by the Danish diabetes care giant Novo Nordisk, has been registered in Russia by a local drugmaker, the Pharma Letter’s local correspondent reports. 18 October 2023
October marks the annual Rett Syndrome Awareness Month, a time to examine the support and research being afforded to advance pharmacological treatments for this rare condition. 18 October 2023
Despite statements from international pharmaceutical companies about the suspension of new clinical trials in Russia after February 24, 2022 invasion of Ukraine, the Anglo-Swedish drug major AstraZeneca will conduct a study of a new drug for the prevention of COVID-19 in Russia, reports The Pharma Letter’s local correspondent. 18 October 2023
US antiviral-focused biotech Assembly Biosciences saw its share price rocket nearly 95% to $1.42, on news of a research collaboration with Gilead Sciences. 17 October 2023
Spanish genetic medicines company SpliceBio has signed an exclusive collaboration and licensing agreement with Spark Therapeutics, which was acquired by Swiss pharma giant Roche in a $4.8 billion deal in 2020, to utilize SpliceBio’s proprietary Protein Splicing platform to develop a gene therapy for an undisclosed inherited retinal disease. 17 October 2023
A formal disclosure from Aldeyra Therapeutics, suggesting a potential rejection from the US Food and Drug Administration, has stripped around 70% from the firm’s share price. 17 October 2023