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.
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
Roche today released positive top-line results of the Phase III CENTERSTONE study of Xofluza (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. 19 September 2024
US contract development and manufacturing organization (CDMO) BioCentriq has appointed Syed Husain as its new chief executive (CEO), and as a member of the board of directors. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Upstream Bio, a clinical-stage biotechnology company, has filed for an initial public offering, listing on the Nasdaq under the ticker symbol "UPB." 19 September 2024
Denmark-based Bavarian Nordic and Gavi, the Vaccine Alliance yesterday announced an advance purchase agreement (APA) to secure 500,000 doses of the MVA-BN mpox vaccine (marketed as Jynneos or Imvanex) to be supplied to countries in Africa impacted by the mpox outbreak. 19 September 2024
The atopic dermatitis (AD) market is on track to reach $16.7 billion across mature markets by 2030, according to data and analytics company GlobalData. 19 September 2024
TG Therapeutics yesterday shared new five-year data from the ULTIMATE I & II Phase III trials evaluating Briumvi (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
Canada’s NanoVation Therapeutics, a privately-held platform company developing innovative technologies to overcome the barriers of nucleic acid delivery, has announced a multi-year partnership with Danish drugmaker Novo Nordisk. 18 September 2024
MAIA Biotechnology, a US biopharmaceutical company developing targeted immunotherapies for cancer, has announced a positive update on its lead clinical candidate. 18 September 2024
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
USA-based ArriVent BioPharma has entered into a collaboration agreement with a unit of Chinese biotech Alphamab Oncology, to discover, develop and commercialize novel antibody-drug conjugates (ADCs) for the treatment of cancers. 6 June 2024
Ireland-headquartered Mallinckrodt has released new data on Terlivaz (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function. 6 June 2024
Top-line data from the randomized, placebo-controlled Phase III MITIGATE study demonstrated Uplizna (inebilizumab) met all primary and key secondary endpoints in treating immunoglobulin G4-related disease (IgG4-RD), US biotech major Amgen announced. 5 June 2024
Privately-held US biotech Bluejay Therapeutics today announced positive preliminary data from the Phase II study of BJT-778, at the European Association for the Study of the Liver (EASL) Congress 2024. 5 June 2024
As more biologics drugs lose their patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. 5 June 2024
US biotech major Gilead Sciences has announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary biliary cholangitis (PBC), a rare, chronic inflammatory liver disease. 5 June 2024
Italy’s Philogen and Indian drugmaker Sun Pharmaceutical Industries have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun). 5 June 2024
Russian drugmaker Nanolek plans to accelerate its expansion this year by expanding its range and increase of output, paying a particular focus to vaccines, The Pharma Letter’s local correspondent reports. 5 June 2024
Lykos Therapeutics’ hopes of being the first to market with a hallucinogenic medicine suffered a major blow Tuesday during a meeting of the US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC). 5 June 2024
Ireland-headquartered fish oil-based heart drug specialist Amarin Corporation announced that it has appointed Aaron Berg, currently Amarin’s executive vice president and president of the US business, as president and chief executive (CEO). 5 June 2024
Shares in California, USA-based autoimmune specialist Annexon soared more than 37% in pre-market trading on Tuesday to $6.32, after it announced positive top-line results from its randomized placebo-controlled pivotal Phase III trial in patients with Guillain-Barré syndrome (GBS). 5 June 2024
San Diego, USA-based biopharma company Viking Therapeutics has announced favorable 52-week results from its Phase IIb VOYAGE study of VK2809. 5 June 2024
Florida, USA-based Summit Therapeutics has managed to beat the leading checkpoint blocker, Keytruda (pembrolizumab), in a head-to-head comparison. 4 June 2024
Treos Bio, a biotech using data science and proprietary biomarkers to develop precision peptide immunotherapies, has presented results from its Phase II OBERTO-301 study. 4 June 2024