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 Israel-based clinical-stage cancer immunotherapy company Compugen leapt as much as a massive 184% to $2.07 on the news of a licensing deal. 19 December 2023
Avacta Group, a UK life sciences company developing innovative, targeted oncology drugs and diagnostics, has appointed Simon Bennett as chief business officer of the therapeutics division. 19 December 2023
Midsize Japanese drugmaker Otsuka Pharmaceuticals has entered into a licensing agreement with Ionis Pharmaceuticals related to its candidate donidalorsen. 19 December 2023
German mRNA specialist BioNTech has inaugurated a major new manufacturing site in Rwanda, significantly boosting infrastructure for advanced therapies in the region. 19 December 2023
US biotech major Biogen today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of the company’s multiple sclerosis therapy, Tecfidera (dimethyl fumarate). 19 December 2023
Shares of Innate Pharma were up 4.5% at 2.45 euros mid-afternoon, after it announced that French pharma major and Sanofi has progressed their collaboration. 19 December 2023
Hoping to capitalize on a tsunami of interest in GLP-1 agonists for weight loss, Structure Therapeutics has now published Phase IIa data for its oral candidate, but investors are not happy. 19 December 2023
Amid the ever-declining drug imports from Western countries, Russia is ready to increase supplies of drugs from so-called “friendly” countries, The Pharma Letter’s local correspondent report. 19 December 2023
In a new move within the pharmaceutical industry, French pharma major Sanofi has entered into a $140 million deal with Aqemia, a French pharmaceutical technology company. 19 December 2023
UK pharma major GSK (LSE: GSK) has released positive headline results from a planned analysis of Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial investigating Jemperli (dostarlimab). 19 December 2023
The European Commission has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged five to 11 years with homozygous familial hypercholesterolemia (HoFH). 19 December 2023
US biotech bluebird bio saw a negative reaction to its proposed sales of shares, with the stock closing down 6.7% and a further15.6% to $2.575 in after-hours trading on Monday. 19 December 2023
Vicore Pharma, a Swedish pharma company seeking to unlock the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), has announced that Bertil Lindmark will join as chief medical officer. 18 December 2023
US women’s health specialist Organon today announced an agreement with pharma major Eli Lilly to become the sole distributor and promoter for two of the latter’s migraine medicines, 18 December 2023
Lif, the industry organization for Danish and foreign pharmaceutical companies in Denmark, has held a debate to discuss access to new medicines. 18 December 2023
New Jersey, USA-based cancer company Bristol Myers Squibb has announced that the Phase III RELATIVITY-123 trial will be stopped, based on a futility analysis. 18 December 2023