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
UK pharma major AstraZeneca has outlined plans to invest £650 million ($828 million) in the UK – helping boost the UK’s life sciences sector and grow the economy. 7 March 2024
UK pharma major GSK today announced positive headline results from an interim analysis of the DREAMM-8 Phase III head-to-head trial evaluating Blenrep (belantamab mafodotin). 7 March 2024
The UK’s leading pharmaceutical and biotechnology trade groups welcomed Chancellor Jeremy Hunt’s Spring Budget to unlock investment in medical research and manufacturing that was announced on Wednesday. 6 March 2024
Israeli company BiomX has entered into a definitive merger agreement with Adaptive Phage Therapeutics, a USA-based, privately-held, biotech developing phage-based therapies to combat bacterial infections. 6 March 2024
US antiviral drug specialist Gilead Sciences has entered into a research collaboration, option and license agreement with Dutch biotech Merus to discover novel dual tumor-associated antigens (TAA) targeting trispecific antibodies. 6 March 2024
A bold move to rip up intellectual property protections for COVID-19 vaccines appears to have been quietly dropped, after the World Trade Organization (WTO) opted not to extend the measure. 6 March 2024
US drugmaker Vanda Pharmaceuticals saw its shares close down 3% yesterday and fall a further 2.2% to $4.04 pre-market on news of a setback for its Hetlioz (tasimelteon) 6 March 2024
Sandoz has announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. 6 March 2024
Sales of Gilead Sciences’ antiviral medication Veklury (remdesivir) decreased by 44% to $2.2 billion last year compared to 2022, primarily driven by lower rates of COVID-19 related hospitalizations in all regions. 6 March 2024
Early data from the AFFINITY DUCHENNE trial of a new gene therapy, RGX-202, raise hopes for a breakthrough in Duchenne muscular dystrophy (DMD). 6 March 2024
Today Boston, USA-based Sionna Therapeutics announced it closed a $182 million Series C financing, one of the largest late-stage rounds in biotech so far this year. 6 March 2024
Marking a fourth deal this year, Japanese drugmaker Ono Pharmaceutical today announced that it has entered into a license agreement with pre-clinical stage Korean biotechnology NEX-I for NXI-101. 6 March 2024
Shares of Sweden-headquartered Calliditas Therapeutics were up 6.8% at 116.60 kronor by mid-morning after revealing a patent extension on its lead product. 6 March 2024
Progress is happening in the cell and gene therapies (CGT) space—but that does not mean that the challenges that have held it back are about to disappear. 6 March 2024
A pair of big pharma companies have become the latest drugmakers to take aim at the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 5 March 2024
A preliminary report from the US Food and Drug Administration could raise concerns about the safety of new vaccines for respiratory syncytial virus (RSV). 5 March 2024