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
US drugmaker Eli Lilly had expected to hear whether its amyloid plaque-targeting therapy donanemab had been approved in the USA to treat early symptomatic Alzheimer's disease by the end of last year. 8 March 2024
Singapore-based TauRx Pharmaceuticals, which is seeking treatments for Alzheimer’s and related neurodegenerative diseases, presented the 24-month data from its Phase III LUCIDITY trial of hydromethylthionine mesylate (HMTM). 8 March 2024
After the debacle surrounding Aduhelm (aducanumab), Leqembi (lecanemab) was supposed to be the Alzheimer’s amyloid beta-directed antibody that delivered results for patients and its manufacturers Eisai and Biogen. 8 March 2024
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
The US Food and Drug Administration (FDA) yesterday approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. 8 March 2024
Novo Nordisk’s investments in GLP-1 agonism and related approaches to weight loss are continuing to bear fruit, as shown by striking headline data from the STEP-1 trial. 8 March 2024
India's drug manufacturers are lobbying for a one-time exemption from a price control regulation linked to the Wholesale Price Index (WPI). 8 March 2024
Germany’s Merck KGaA will hope to draw a line under a challenging year as it predicts a return to growth in 2024—albeit when adjusted for currency headwinds. 7 March 2024
A key committee of the US Senate has given its stamp of approval for the BIOSECURE Act, which aims to prevent contracts with Chinese biotech companies. 7 March 2024
French drugmaker Ipsen has secured a positive reimbursement decision from the UK’s National Institute for Health and Care Excellence (NICE). 7 March 2024
Staying true to her values is not a secondary consideration for Dr Dennise Broderick in her career and leadership of Galen, but rather is front and central to every action she takes. 7 March 2024
The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). 7 March 2024
In a filing with the US Securities and Exchange Commission (SEC), Boundless Bio has revealed its intention for an initial public offering (IPO). 7 March 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Rystiggo (rozanolixizumab), from Belgium’s largest drug maker UCB. 7 March 2024
The US subsidiary of Germany’s family-owned drug major Boehringer Ingelheim today said it will cap out-of-pocket costs at $35 per month for eligible patients for all the company’s inhaler products. 7 March 2024
President Joe Biden’s actions to cut prescription drug prices through the Inflation Reduction Act (IRA) and other means have been far from popular with big pharma and its lobbyists. 7 March 2024
UK-based Ellipses Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive non-small cell lung cancer (NSCLC). 7 March 2024
South Korean vaccine maker SK bioscience today announced that it has broken ground on a major expansion of its vaccine manufacturing plant, L HOUSE, located in Andong, Gyeongsangbuk-do. 7 March 2024