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 European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
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
US ophthalmic drug developer Aldeyra Therapeutics saw its shares leap 48.5% to $2.54 yesterday after it announced the signing of a deal with pharma major AbbVie 2 November 2023
The Crohn's disease (CD) treatment arena is set for a notable transformation, with novel therapies expected to drive significant market growth. 2 November 2023
The European Medicines Agency (EMA) has validated the submission for Braftovi (encorafenib) with Mektovi (binimetinib), submitted by privately-held French drugmaker Pierre Fabre, for the treatment of adult patients with BRAFV600-mutant advanced non-small cell lung cancer (NSCLC). 2 November 2023
Indian contract development and manufacturing organization (CDMO) Aragen is to build a new biologics manufacturing facility in Bangalore. 2 November 2023
US ophthalmic drug developer Ocuphire Pharma has appointed Dr George Magrath, as chief executive and member of the board of directors, effective today. 2 November 2023
Danish diabetes care giant Novo Nordisk today reported record sales and operating profits for the third quarter of 2023, but cautioned it would keep in place restrictions on supplies of its much in demand Wegovy(semaglutide) weight-loss drug. 2 November 2023
The US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Committee concluded that Vertex Pharmaceutical and Swiss gene editing specialist CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel) is generally safe for clinical use. 1 November 2023
Merck & Co has secured another approval from the US Food and Drug Administration for its blockbuster immuno-oncology product, Keytruda (pembrolizumab). 1 November 2023
British pharma major GSK has surpassed market expectations, announcing a 10% increase in total sales, and a 16% rise when excluding COVID-19 impacts. 1 November 2023
French biotech Cellectis saw its shares rocket 149% to 2.24 euros by mid-afternoon trading today, on news of a collaboration an investment deal with UK pharm major AstraZeneca. 1 November 2023
Shares of Japanese pharm major Shionogi rose 2.4% to 7,152 yen, as the company announced a $150 million transaction with US clinical-stage firm Apnimed. 1 November 2023
Adding to recent regulatory approvals in the USA and European Union, pharma giant Pfizer can now add the UK to the geographies where its alopecia treatment can be marketed. 1 November 2023
The US Food and Drug Administration (FDA) yesterday announced it has approved US biotech major Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. 1 November 2023
On Tuesday, US biotech company Novavax, which is advancing protein-based vaccines with its Matrix-M adjuvant, announced a timely update with its Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted). 1 November 2023
US biotech giant Amgen saw its shares fall by 4.4% to $251.44 on Tuesday, after it announced financial results for the third quarter of 2023. 1 November 2023
Swiss pharma major Novartis has secured another approval from the US regulator for Cosentyx (secukinumab), a biologic which blocks the IL-17A cytokine. 1 November 2023
UK clinical-stage biotech STORM Therapeutics, which is targeting RNA modifying enzymes (RMEs) for oncology and other diseases, has appointed Marguerite Hutchinson as its chief business officer. 1 November 2023