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
New information from senior executives at the US Food and Drug Administration casts light on its recent decision to apply a black box warning to certain CAR-T cell therapies. 26 January 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its January 2024 meeting, but rejected two others. 26 January 2024
Osivax, a French biopharma developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses and diseases, has named Nicola Groth its new chief medical officer (CMO). 26 January 2024
US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of KarXT (xanomeline tartrate/trospium chloride) drug KarXT, from Karuna Therapeutics for the treatment of schizophrenia. 26 January 2024
The US Food and Drug Administration (FDA) has provided an update on its review of the New Drug Application (NDA) for Yutrepia (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). 26 January 2024
Shares of Dutch biotech LAVA Therapeutics shot up 43% to $2.23 by close of trading on Thursday, after it revealed a clinical trial collaboration and supply agreement with US pharma giant Merck & Co. 26 January 2024
In early December, the USA’s Biden administration announced a proposed framework under the Bayh-Dole Act that would allow the government to seize patent rights on products developed with any federal funding if they don’t agree with the price, using the “march-in” provision. 26 January 2024
The UK’S Medicines and Healthcare products Regulatory Agency (MHRA) has approved a four-dose version (covering a month’s treatment) of the diabetes and weight management medicine Mounjaro (tirzepatide) - Mounjaro KwikPen. 26 January 2024
Products from biotech major Gilead Sciences appear twice on a US Food and Drug Administration (FDA) list of six cell therapies that are to carry black box warnings about the risk of T-cell malignancies. 25 January 2024
Cellular Origins, a part of TTP Company, focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies, today announced the appointment of Peter Crossley as chief operating officer (COO). 25 January 2024
Korean immuno-oncology company CanariaBio has taken a stock market battering following the failure of its Phase III trial of oregovomab, an antibody targeting CA125, for ovarian cancer patients. 25 January 2024
Belgian cell therapy biotech BioSenic will, for the first time, share post hoc data on its late-clinical asset JTA-004 at the Osteoarthritis Research Society International (OARSI) World Congress 2024. 25 January 2024
The European regulatory filing for Acarizax (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review by the relevant health authorities via a type II variation 25 January 2024
UK-based dermatology company SkinBioTherapeutics is to acquire the issued share capital of Dermatonics, a specialist in innovative topical and dermatological products in the skincare and woundcare space. 25 January 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin, submitted by Montreal, Canada-based Theratechnologies . 25 January 2024
San Diego, USA-based precision cancer medicines developer Kura Oncology saw its shares rocket more than 46% to $19.62 yesterday it announced a $150 million oversubscribed private placement. 25 January 2024
Earlier this week, ArriVent Biopharma filed for an IPO, following several other young biotechs giving notice they planned to take the plunge in 2024. 25 January 2024