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 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
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. 19 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
Tesaro, a subsidiary of UK pharma major GSK, has come up on top in the latest stage of its legal battle with Anglo-Swedish drugmaker AstraZeneca regarding the ovarian cancer drug Zejula (niraparib). 15 February 2024
San Diego, USA-based precision oncology company Erasca announced two clinical trial collaboration and supply agreements (CTCSAs) with Swiss pharma giant Novartis for the MEK inhibitor Mekinist (trametinib). 15 February 2024
US biopharma Merrimack Pharmaceuticals has revealed plans to dissolve and hand out cash to shareholders from a newly-announced milestone payment that the company is to receive. 15 February 2024
Cathal Friel, co-founder, substantial shareholder, and currently non-executive chairman of London-listed Poolbeg Pharma, is assuming the role of executive chairman at the company effective immediately. 15 February 2024
India has achieved a notable milestone in the field of cancer treatment with its indigenously developed CAR-T cell therapy, resulting in the first patient being declared cancer-free post treatment. 15 February 2024
Japan’s Ono Pharmaceutical yesterday revealed that it has entered into an option and collaboration agreement with Swiss biotech Numab Therapeutics. 15 February 2024
Today, the US Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. 14 February 2024
French pharma major Sanofi is angry that its interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab) has been recommended for the treatment of moderate-to-severe prurigo nodularis (PN) in Scotland but not in England and Wales. 14 February 2024
Spanish plasma-derived products specialist Grifols has announced positive, top-line Phase III data for BT524, a fibrinogen concentrate being studied to treat patients with acquired fibrinogen deficiency, a bleeding disorder. 14 February 2024
Shares in AN2 Therapeutics, a US biopharma focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, closed 74% lower on Monday. 14 February 2024
US oncology company G1 Therapeutics was hoping for a positive interim analysis in its pivotal Phase III of trilaciclib alongside gemcitabine and carboplatin for the first-line treatment of metastatic triple negative breast cancer (mTNBC). 14 February 2024
After four years in stealth, California, USA-based biotech Latigo Biotherapeutics today announced its emergence with a $135 million Series A financing. 14 February 2024
The US Food and Drug Administration (FDA) has extended the Priority Review period for the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; formerly RP-L201) for severe leukocyte adhesion deficiency-I (LAD-I). 14 February 2024
China-based biotech Brii Biosciences has entered into a second agreement with VBI Vaccines, sending the US firm’s up almost 10% to $0.72 in pre-market activity. 14 February 2024
The US Food and Drug Administration (FDA) has approved Onivyde (irinotecan liposome), from French drugmaker, in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX regime), for the first-line treatment of metastatic pancreatic adenocarcinoma (mPDAC). 14 February 2024
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has made clear its opposition to the drug price-setting provisions in the Biden administration’s Inflation Reduction Act (IRA). 14 February 2024
Non-governmental organization Médecins Sans Frontières (MSF) has issued a warning about the details of a trade deal that is about to be agreed by India and the European Free Trade Association (EFTA). 14 February 2024
US AI-enabled drug discoverer VantAI has entered into a strategic collaboration with pharma major Bristol Myers Squibb to discover new molecular glues for therapeutic targets of interest. 14 February 2024
Leading Australian biotech CSL Limited has reported financial results for the six months to December 31, 2023, showing that revenue came in at A$8.05 billion ($12.3 billion, up 11% at constant currency (CC). 14 February 2024
Clinical stage gene therapy company MeiraGTx Holdings announced the achievement of the first milestone under the asset purchase agreement with Janssen Pharmaceuticals. 14 February 2024