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
After decades without a breakthrough, scientists targeting the respiratory syncytial virus (RSV) have notched up three successes in a period of around a year. 2 January 2024
From January 1, 2024, developers of new medicines can now submit applications via the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new, International Recognition procedure (IRP). 2 January 2024
Privately-held Italian drugmaker Alfasigma has signed an agreement with Belgium’s Galapagos to acquire the Jyseleca (filgotinib) business. 2 January 2024
British and American biotech Apollo Therapeutics has boosted its series C financing round by $33.5 million, bringing the total amount to $260 million. 2 January 2024
China’s National Medical Products Administration (NMPA) has approved Japanese pharma major Takeda’s antiviral drug Livtencity (maribavir). 29 December 2023
South Korean biotech LegoChem Biosciences has entered into a license agreement with Janssen Biotech, to develop and commercialize LCB84. 29 December 2023
US biotech Iovance Biotherapeutics saw its shares drop more than 20% on Tuesday, after it revealed a setback with its clinical program for LN-145 TIL therapy in non-small lung cancer (NSCLC). 29 December 2023
US oncology drug developer Oncternal Therapeutics took a 10% initial tumble after it revealed a patient in an early-stage trial of its ONCT-808, but closed the day up 18% at $0.59. 29 December 2023
Singapore-based Novotech, an Asia-Pacific-focused contract research organization (CRO), has presented research on financial shifts in the biotech industry in 2023. 29 December 2023
Vertex Pharmaceuticals and CRISPR Therapeutics made history last month by gaining approval for the first CRISPR-based drug, Casgevy (exagamglogene autotemcel). 29 December 2023
Russia may be faced with a shortage of some important antibiotics next year due to the recent decision of some global drugmakers to withdraw them from the market, The Pharma Letter’s local correspondent reports. 29 December 2023
Just a few days after punting $14 billion to acquire Karuna, Bristol Myers Squibb has announced a definitive agreement to take over radiopharmaceuticals-focused drug developer RayzeBio. 28 December 2023
Privately-held Chinese firm Elpiscience Biopharma has inked a deal with Japan’s Astellas Pharma related to two novel bi-specific macrophage engagers (BiME). 28 December 2023
India's aspiration for pharmaceutical self-reliance hit a rough patch as recent data indicates a surge in imports of bulk drugs and intermediates from various countries, including China, over the past two years. 28 December 2023
Chinese biopharma Innovent Biologics and Xuanzhu Biopharma have entered into a clinical trial collaboration and supply accord for the combination therapies of Tyvyt (sintilimab) injection with KM-501. 28 December 2023
Californian biotech Amgen has announced that the US Food and Drug Administration has rejected its bid for full approval of Lumakras (sotorasib). 28 December 2023
The level of competition in the Russian pharmaceutical market will significantly tighten next year, as local drugmakers plan to overtake global producers in the segment of public procurements, reports The Pharma Letter’s local correspondent. 28 December 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12. 28 December 2023
The market for Gaucher disease is set to experience a compound annual growth rate (CAGR) of 0.79% across the seven major markets from $1.2 billion in 2022 to $1.3 billion in 2032. 28 December 2023
Shares in US muscle biology specialist Cytokinetics soared 70% to $77.34 this morning, as it announced positive results from the much-awaited SEQUOIA trial of its aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). 27 December 2023