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
A new partnership will see Japanese pharma major Takeda and India’s Biological E (BE) working together to accelerate access to Qdenga (dengue vaccine). 27 February 2024
The US Food and Drug Administration (FDA) has approved the marketing application for Exblifep (cefepime/enmetazobactam), submitted by Franco-German firm Allecra Therapeutics. 27 February 2024
When James Burt, the chief executive of lifecycle management healthcare company Pharmanovia, looks back at the mood in the pharma industry in 2023, he is happy to say that he is already experiencing a greater sense of optimism in 2024. 27 February 2024
Further expanding its therapeutic range, Danish diabetes and obesity giant Novo Nordisk has entered into a collaboration and licensing agreement with US biotech Neomorph to discover, develop and commercialize molecular glue degraders beyond oncology. 27 February 2024
Japanese drugmaker Shionogi says it has submitted a marketing approval application for the digital therapeutic app SDT-001, for commercialization and sale in Japan. 27 February 2024
Privately-held UK biotech Curve Therapeutics today announced the closing of its successful £40.5 million ($51.4 million) Series A financing. 27 February 2024
Germany’s Boehringer Ingelheim has announced positive results from a Phase II trial of survodutide, a glucagon/GLP-1 receptor dual agonist. 26 February 2024
Dame June Raine, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has today announced that she will be stepping down in the fall following five years in the role. 26 February 2024
US hematology specialist Disc Medicine today announced the appointment of Pamela Stephenson as the company’s chief commercial officer. 26 February 2024
Teva Pharmaceutical Industries has formed a partnership with Jiangsu Nhwa Pharmaceutical for the marketing and distribution in China of Teva’s Austedo (deutetrabenazine). 26 February 2024
US biotech major Amgen has made clear its objectives in rare disease, the company’s newest therapeutic area pillar, to drive long-term growth. 26 February 2024
The European Federation of Pharmaceutical Industries and Associations (EFPIA), as part of a coalition of 35 large health stakeholder organizations, is expressing its shared concerns about the latest negotiations on the proposed Regulation on the European Health Data Space (EHDS). 26 February 2024
The European Free Trade Association (EFTA) aims to conclude a trade agreement with India "within weeks," with the four-nation bloc showing a steadfast commitment to seal the deal before the Asian country enters its election cycle. However, concerns persist over a clause that may delay access to generic drugs in India for up to six years. 26 February 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for cefepime-taniborbactam. 26 February 2024
Icelandic firm Alvotech and Israel’s Teva Pharmaceutical Industries on Friday announced that the US Food and Drug Administration (FDA) has approved Simlandi (adalimumab-ryvk) injection. 26 February 2024