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
Not long after the first home-grown GLP-1 agonist was approved in China, the country’s thriving biotech sector looks set to progress another novel candidate in this class with strong potential. 4 January 2024
A significant collaboration agreement has been reached between Belgian biotech Galapagos and private Californian company BridGene Biosciences. 4 January 2024
US pharma company Esperion Therapeutics on Wednesday announced a $125 million deal with Japanese drugmaker Daiichi Sankyo’s European subsidiary (DSE) to resolve Esperion's demand for $300 million from the company over Esperion's cholesterol reduction drugs. 4 January 2024
US clinical-stage biotech start-up QurAlis has announced the opening of its European Union (EU) headquarters in Leiden, the Netherlands. 4 January 2024
French immuno-oncology company Innate Pharma today announced that it has strengthened its leadership and corporate governance with the appointment of two new executive board members. 4 January 2024
Adding to the growing list pf big pharma licensing and M&A deals in the attractive area of antibody-drug conjugate (ADC) drugs, China-headquartered MediLink Therapeutics has entered into a worldwide collaboration and license accord with Swiss pharma giant Roche. 3 January 2024
Privately-held British drugmaker Mundipharma has secured European approval for Rezzayo (rezafungin), for the treatment of invasive candidiasis in adults. 3 January 2024
US clinical-stage immunotherapy specialist ImmunityBio yesterday announced an up to $320 million royalty financing and equity investment in the company by Oberland Capital. 3 January 2024
The life sciences landscape has adapted in tandem with data management solutions over the past several years, attracting significant investment. However, these solutions lack the ability to rapidly address and complement existing pain points and previous investments with the latest technological innovations. 3 January 2024
UK-based Arecor Therapeutics has announced the appointment of Dr Helen Parris as senior vice president, commercial and general manager of Tetris Pharma. 3 January 2024
China and USA-based Allorion Therapeutics has entered into an exclusive option and global license agreement with UK pharma major AstraZeneca. 3 January 2024
Shares of US neurogenetic focused biotech Voyager Therapeutics shot up 30% to $10.86 today, after it announced a capsid license agreement and strategic collaboration with Novartis. 2 January 2024
Shares of Denmark-based Zealand Pharma dipped 4.9% to 355.00 kroner by late afternoon, on negative news from the US medicines regulator. 2 January 2024
UK-based biotech Sareum Holdings saw its shares gain 18% to 70.00 pence by early afternoon after it announced that is co-development partner, the CRT Pioneer Fund (CPF), has entered into a development and commercialization licence agreement for SRA737 with a private biopharma company based in the USA. 2 January 2024