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
Process changes for the assessment of established medicines have been published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday March1, 2024. 29 February 2024
Medicines for Europe, a trade group for the European generics industry, has welcomed the position adopted today by the European Parliament regarding SPC regulation. 28 February 2024
Riding high after a high-profile victory over erstwhile US President Donald Trump, New York Attorney General Letitia James has set her sights on another emotive issue - the safety of certain medicines given to children. 28 February 2024
USA-based rare disease Applied Therapeutics today announced that the US Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of classic galactosemia 28 February 2024
San Diego, USA-based Janux Therapeutics has seen its share price triple after positive early data were announced for JANX007 and JANX008. 28 February 2024
Indian drugmaker Cipla Limited says it has received approval from the Central Drugs Standard Control Organization (CDSCO) to market the novel antibiotic Zemdri (plazomicin) in India. 28 February 2024
US neurodegenerative diseases focussed biotech Denali Therapeutics saw its shares rocket more than 38% to $23.35, on news of a $500 million private placement. 28 February 2024
Belgium’s largest drugmaker UCB today reported earnings results for the full year ended December 31, 2023 with a downturn on sales and earnings, but demonstrating significant achievements and sending its shares up 3.5% to 100.50 euros. 28 February 2024
Shares of biotech FibroGen leapt 14.6% to $2.12 by close of trading Tuesday, after it announced a deal with UK pharma major AstraZeneca for roxadustat would be terminated. 28 February 2024
French ophthalmology company Nicox has announced it will replace its chief executive, Andreas Segerros, with current chief business officer Gavin Spencer. 28 February 2024
In the USA, there is growing resistance to a bid from the White House to exercise so-called march-in rights, a process whereby the federal government requires patent holders to agree to a licence. 27 February 2024
Antiviral specialist Gilead Sciences has announced a new approval from the US Food and Drug Administration, for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). 27 February 2024
USA-based Pelage Pharmaceuticals, a clinical-stage regenerative medicine company developing treatments for hair loss, has closed a $16.75 million Series A financing. 27 February 2024
The US Food and Drug Administration (FDA) has granted Priority Review of the supplemental Biologics License Application (sBLA) submitted by Denmark's Genmab and US pharma major AbbVie for Epkinly (epcoritamab-bysp). 27 February 2024
US clinical-stage cell therapy developer Vittoria Biotherapeutics today said that accomplished life sciences leader, Rosemary Mazanet, has joined the company as chief medical officer. 27 February 2024