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
Industry commentator GlobalData has produced research into growth in the pharma contract manufacturing sector, noting a strong increase in investments. 1 December 2023
Privately-held Swiss dermatology company Galderma has turned a frown into a smile in sharing the latest news on its drug relabotulinumtoxinA (QM-1114), a novel liquid formulation botulinum toxin A. 30 November 2023
British biotech Levicept has appointed Eliot Forster as chief executive, with the company’s founder, Simon Westbrook, taking up the role of chief scientific officer. 30 November 2023
Japanese pharma major Astellas today presented 24-week results from the Phase IIIb DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, at the 15th Congress of the European Society of Gynecology (ESG) in Amsterdam. 30 November 2023
Shares of US antibody-drug conjugate (ADC) specialist ImmunoGen shot up more that 83% to $29.46 pre-market today, on the news of a definitive agreement to be acquired by pharma major AbbVie. 30 November 2023
Boston, USA-based biopharma Karuna Therapeutics has announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) to treat schizophrenia in adults. 30 November 2023
Industry analyst GlobalData has highlighted the potential of CAR T-cell therapy advancements in China, noting a relative lack of partnerships with global pharma companies. 30 November 2023
Top-line results from the single-arm Phase II LUMINOSITY trial evaluating telisotuzumab-vedotin (Teliso-V) in patients with c-Met protein overexpression, epidermal growth factor receptor (EGFR) wild type, advanced/metastatic non-squamous non-small cell lung cancer (NSCLC) have been released by AbbVie. 30 November 2023
Canada-headquartered Phenomic AI yesterday revealed a strategic collaboration and licensing agreement with family-owned German pharma major Boehringer Ingelheim to discover targets important in stroma-rich cancers. 30 November 2023
Several Latin American countries, given their processes of political change, are immersed in deep discussions about transforming their health systems, writes The Pharma Letter's local correspondent. 29 November 2023
The National Institute for Health and Care Excellence (NICE) has opted against recommending Crysvita (burosumab) to treat adults in England and Wales who have a confirmed diagnosis of X-linked hypophosphataemia (XLH). 29 November 2023
UK biotech Arecor Therapeutics’ shares edged up more than 2% to 190.00 pence today, after it announced the signing of further collaboration agreement with US pharma major Eli Lilly. 29 November 2023
As political leaders from around the world get ready to meet at the COP 28 climate conference, life science companies are taking steps to encourage sustainability within industry. 29 November 2023
California, USA-based biotech firm BioMarin Pharmaceutical (Nasdaq: BMRN) has announced an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement amount for Roctavian (valoctocogene roxaparvovec-rvox) for people with severe hemophilia A. 29 November 2023
Tokyo-based Daiichi Sankyo (TYO: 4568) has announced that its booster vaccine Daichirona for Intramuscular Injection (DS-5670) has been approved as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19. 29 November 2023
Belgian biotech Agomab Therapeutics today announced the appointment of Dr Angelika Jahreis as an independent non-executive director to its board of directors, while Andrea Sáez will join Agomab’s executive leadership team as chief development officer. 29 November 2023
The US Food and Drug Administration (FDA) yesterday said it has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous chimeric antigen receptor (CAR)-T cell immunotherapies. 29 November 2023
Industry lobbyist Pharmaceutical Research and Manufacturers of America (PhRMA) has criticized greater use of prior authorization in Medicaid. 29 November 2023