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
One big challenge for pharma companies doing cross-border businesses in China and the USA is the respective cybersecurity law imposed by the two countries. 12 October 2023
German eye disease specialist Katairo GmbH today announced top-line results of a multi-national, multicenter, double-masked, placebo-controlled, proof of concept trial to evaluate the safety and efficacy of oral Remofuscin (soraprazen) in adults with Stargardt disease. 12 October 2023
Research company Care Access has announced the completion of a for-cause US Food and Drug Administration (FDA) Good Clinical Practices (GCP) inspection related to Care Access’s activities on the Pfizer VALOR trial. 12 October 2023
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Icelandic firm Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Johnson & Johnson Stelara (ustekinumab). 12 October 2023
The British medicines regulator has initiated a new scheme designed to reduce the amount of time it takes to approve clinical trials which are deemed to be low risk. 12 October 2023
The US Food and Drug Administration has approved US pharma giant Pfizer’s Braftovi (encorafenib) with Mektovi (binimetinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. 12 October 2023
Genentech announced new clinical and real-world data on its anti-CD20 therapy Ocrevus (ocrelizumab) at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis) that it said “continue to deepen our understanding of multiple sclerosis (MS).” 12 October 2023
Danish allergy immunotherapy specialist ALK Abello today announced positive top-line results from a Phase III pediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of tree-pollen-induced allergic rhinoconjunctivitis. 11 October 2023
A new product from French pharma major Sanofi’s Indian subsidiary, Soliqua (insulin glargine and lixisenatide recombinant fixed-dose combination), has recently been granted approval by the Central Drugs Standard Control Organization (CDSCO). 11 October 2023
Patrick Branch, a Japan-based strategy consultant from LEK Consulting, provides an Expert View on the ‘new map’ for healthcare firms in Asia. 11 October 2023
Swedish company Egetis Therapeutics has raised around $16 million in a private share placement led by US healthcare investor Frazier Life Sciences. 11 October 2023
UK clinical-stage biotech PureTech Health has presented new clinical data supporting the differentiated profile of LYT-100 (deupirfenidone) at the CHEST Annual Meeting in Honolulu, Hawaii. 11 October 2023
Danish biotech MinervaX, a privately held firm working on a novel, prophylactic vaccine against Group B Streptococcus (GBS), has raised $57 million from a range of new and existing sources of finance. 11 October 2023
Danish diabetes care giant Novo Nordisk saw its shares rise 3.7% to 673.90 kroner today, on positive news announced to the stock exchange late on Tuesday. 11 October 2023
With the aim of advancing its fibrosis-focused pipeline, Belgian biotech Agomab Therapeutics today announced the closing of a $100 million (94.9 million euros) Series C financing. 11 October 2023
Samsung Bioepis, a business of South Korea-based Samsung BioLogics has outlined data it is presenting at the ongoing congress of the European Academy of Dermatology and Venereology (EADV). 11 October 2023
BioMap today announced a ground-breaking strategic collaboration with French pharma major Sanofi to co-develop cutting-edge artificial intelligence (AI) modules for biologic therapies leveraging BioMap’s AI platform. 11 October 2023