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
Trade group the Association of the British Pharmaceutical Industry (ABPI) has published an executive summary of its consultation response to the government's proposed changes to the Statutory Scheme for branded medicines. 1 May 2024
UK clinical-stage biotech Barinthus Biotherapeutics, formerly Vaccitech, today announced the appointment of Dr Leon Hooftman as chief medical officer (CMO). 1 May 2024
Shares in USA-based NRx Pharmaceuticals have fallen by around a fifth, after the firm announced disappointing results from a trial of NRX-101. 1 May 2024
UK pharma major GSK today reported first quarter 2024 financial results, showing that total sales were £7.4 billion ($9.26 billion) +10% and +13% ex COVID revenues. 1 May 2024
Californian biotech Enlaza Therapeutics has raised $100 million in a series A financing led by J.P. Morgan Asset Management’s Private Capital division. 1 May 2024
The USA’s Federal Trade Commission yesterday revealed it has expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food and Drug Administration’s (FDA) Orange Book, disputing junk patent listings for diabetes, weight loss, asthma and COPD drugs. 1 May 2024
Japanese biotech PeptiDream edged up 3% to 2,081 yen today, after it announced an expansion of its peptide discovery collaboration with Swiss pharma giant Novartis. 1 May 2024
A new age of innovation in immunology could change medical practice and people’s lives, as long as all parts of the system learn, evolve and work together, writes Anant Murthy, General Manager, argenx EMEA, in an Expert View piece. 1 May 2024
UK-based developer of novel immunoglobulin E (IgE) antibodies to treat cancer, Epsilogen, has appointed Ashley Nagle as chief business officer (CBO) with immediate effect as part of a broader company expansion. 1 May 2024
The level of competition in the Russian market of anti-HIV drugs is tightening, due to the plans of global drugmakers to launch their products and expand their existing portfolios, The Pharma Letter’s local correspondent reports. 1 May 2024
US pharma giant Merck & Co has announced results from STRIDE-10, a Phase III trial of V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine (PCV), at the European Society of Clinical Microbiology and Infectious Diseases event in Barcelona, Spain. 30 April 2024
Shares of US developer of rare neurological drugs Harmony Biosciences (Nasdaq: HRMY) rose more than 10% to $32.30 today, after it announced the acquisition of Epygenix Therapeutics. 30 April 2024
US pharma major Eli Lilly today announced its financial results for the first quarter of 2024 and raised it guidance, with the news pushing the firm’s share up 5.6% to $778.19. 30 April 2024
X4 Pharmaceuticals has secured US approval for Xolremdi (mavorixafor), for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). 30 April 2024
A full cycle of production of a drug for the treatment of Fabry disease will be launched in Russia this year, reports The Pharma Letter’s local correspondent. 30 April 2024
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign. 30 April 2024