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
Shares of Dutch immunology specialist Argenx (Euronext: ARGX) have dropped around a tenth following negative results from the ADVANCE-SC study. 29 November 2023
Swiss pharma giant Roche will resume the supply of its cystic fibrosis drug Pulmozyme (dornase alfa), as the company has found the way for its imports to the Russian market, The Pharma Letter’s local correspondent reports. 29 November 2023
US pharma giant Merck & Co has announced results from STRIDE-3, a Phase III trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults. 28 November 2023
US biopharma Novavax has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for its updated COVID-19 jab for active immunization to prevent COVID-19 in people aged 12 and older. 28 November 2023
India's Draft Patents (Amendment) Rules, 2023, that propose several changes to India's patent regime, have raised significant concerns among public health experts, domestic drug industry chiefs, and civil society organizations. 28 November 2023
Shares of US RNA-focussed biotech Avidity Biosciences leapt as much as 35% pre-market, after it announced a global licensing and research collaboration with pharma major Bristol Myers Squibb focused on the discovery, development and commercialization of multiple cardiovascular targets. 28 November 2023
US clinical-stage drug developer Ensysce Biosciences and Sweden’s OncoZenge have signed a letter of intent (LoI) to explore a strategic collaboration to accelerate the commercialization of BupiZenge in the USA. 28 November 2023
Canada’s Xenon Pharmaceuticals has reported top-line results from the Phase II X-NOVA trial, showing the primary efficacy endpoint was not met. 28 November 2023
Citing a failure to show required efficacy, the US Food and Drug Administration has rejected a submission from Aldeyra Therapeutics for its dry eye candidate reproxalap. 28 November 2023
The US Food and Drug Administration (FDA) has accepted and granted priority review for the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), submitted by Abeona Therapeutics. 28 November 2023
Russia will significantly reduce public procurements of anti-cancer drugs which are not included in the list of vital drugs due to the lack of funds, reports The Pharma Letter’s local correspondent. 28 November 2023
USA-based venture capital and private equity company focused on life sciences, Flagship Pioneering, has marked the official opening of its UK hub. 28 November 2023
Roivant Sciences’ shares fell 4.7% to $8.70 in early morning trading yesterday, after it announced the Phase II study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint. 28 November 2023
UK biotech start-up Myricx Bio has announced the publication today of ground-breaking research in Nature Cell Biology by its collaborators at the MRC-LMS (Laboratory of Medical Sciences) that has uncovered the central role of NMT as a druggable pathway in senescence. 28 November 2023
In the USA, the Biden Administration is currently conducting a government-wide review of the use of “march-in” authority under the Bayh-Dole Act. 28 November 2023
British pharma major AstraZeneca has established a new R&D center in Hong Kong, focused on research and development in areas including cell and gene therapies. 27 November 2023
Positive top-line data from the blinded extension phase of its Phase IIb ENLIVEN trial evaluating treatment with pegozafermin in patients with non-alcoholic steatohepatitis (NASH) were released today by 89bio. 27 November 2023