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
A single-line order from the US Supreme Court has scotched hopes on the part of Vanda Pharmaceuticals of resurrecting patents for Hetlioz (tasimelteon). 23 April 2024
In a bid to expand its portfolio of immunology products, US biotech Incyte today announced it plans to acquire privately-held Escient Pharmaceuticals. 23 April 2024
US biopharma Abeona Therapeutics was trading nearly 50% lower in Tuesday morning’s trading after announcing a regulatory update for prademagene zamikeracel (pz-cel). 23 April 2024
Global drugmakers are losing their market share in the Russian market for erectile dysfunction drug, which is rapidly being taken over by local players, reports The Pharma Letter’s local correspondent. 23 April 2024
Following an earlier snub, the US Food and Drug Administration has now approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG). 23 April 2024
Long-term partners BioArctic and Eisai have announced a new research agreement regarding BAN2802, a potential treatment combining the former company’s proprietary BrainTransporter technology with an undisclosed Alzheimer drug candidate. 23 April 2024
Cash-laden Vertex Pharmaceuticals has followed up this month’s news of its $4.9 billion buy of US biotech company Alpine Immune Sciences with an announcement of an in-licensing deal. 23 April 2024
Indian pharma exports to the US market are rebounding strongly in the current fiscal year, showing a notable double-digit growth after a lull. 23 April 2024
French drugmaker Ipsen says it has signed an exclusive worldwide collaboration with privately-held US biotech Skyhawk Therapeutics to discover and develop novel small molecules that modulate RNA for rare neurological diseases. 23 April 2024
Swiss pharma giant Novartis today raised its full-year guidance after reporting better-than-expected first-quarter 2024 results, with the firm’s shares rising as much as 4.8% in early trading. 23 April 2024
A first-in-class treatment for paroxysmal nocturnal hemoglobinuria (PNH), Voydeya (danicopan), has been granted marketing authorization in Europe. 23 April 2024
Despite the ongoing uncertainties surrounding macroeconomic activities, fluctuating interest rates, and changes in the US Medicare Drug Price Negotiation landscape, the top 20 global biopharmaceutical companies experienced a promising first quarter this year. 23 April 2024
Oxford, UK-based start-up Ochre Bio, an innovator in chronic liver disease drug development, today announced a partnership with family-owned German pharma major Boehringer Ingelheim. 22 April 2024
Following a positive recommendation last month by the European Medicines Agency’s (EMA) human medicines committee (CHMP), today the European Commission (EC) granted marketing authorization for Emblaveo (aztreonam-avibactam) from Pfizer. 22 April 2024