Sandoz, the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva®* (ustekinumab) across Europe, starting today. Pyzchiva®, developed and registered by Samsung Bioepis, is the first ustekinumab biosimilar […] The post Sandoz launches biosimilar Pyzchiva (ustekinumab) across Europe, to treat chronic inflammatory diseases appeared first on Pharma Journalist ..read more

AC Immune SA, a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the pathologic form of the Tau protein, […] The post AC Immune’s ACI-35.030 (now “JNJ-2056”) Granted FDA Fast Track Designation for Alzheimer’s Disease appeared first on Pharma Journalist ..read more

Ipsen and Day One Biopharmaceuticals (Day One), announced a new global partnership outside the U.S. for tovorafenib, an oral, once-weekly, type II RAF inhibitor for pediatric low grade glioma (pLGG), […] The post Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor appeared first on Pharma Journalist ..read more

Astellas Pharma Inc. and Graduate School of Medicine / Faculty of Medicine, Osaka University announced that Astellas Institute for Regenerative Medicine (a wholly owned subsidiary of Astellas, “AIRM”), Universal Cells (a wholly owned subsidiary of Astellas) and Osaka University have entered into a research collaboration to develop innovative pluripotent stem cell-derived cartilage organoid cell therapy for the treatment of intervertebral disc degenerative disease. Universal Cells holds the rights to Universal Donor Cell (UDC) technology to create cell therapy products from pluripotent stem ce ..read more

The Phase III ARANOTE trial, investigating NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of radiological progression-free survival (rPFS). NUBEQA plus ADT demonstrated a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT. Results were consistent with NUBEQA’s established safety profile with no new signals observed. Detailed results from this randomized, double-blind, placebo-controlled trial are planned to be presented at a forthco ..read more

Rona Therapeutics, a clinical stage pioneering platform company in nucleic acid drug research and development, announced the completion of $35 Million Series A+ financing. This round was led by LongRiver Investments, with participation from investors including Zhaode Investment, BioTrack Capital, Zhongqi Capital and Lilly Asia Ventures. LongRiver Investments will join the board of Rona in connection with the Series A+ financing, commented, “Rona Therapeutics has successfully brought two best-in-class siRNA metabolic programs into global development and demonstrated differentiated clinica ..read more

CatalYm announced the completion of a $150 million Series D financing. The oversubscribed round was led by new investors, Canaan Partners and Bioqube Ventures, and joined by Forbion’s Growth Opportunities Fund (“Forbion Growth”), Omega Funds and Gilde Healthcare. Existing investors Jeito Capital, Brandon Capital Partners, Novartis Venture Fund and Vesalius Biocapital III also participated in the round. The proceeds will fund the expansion of the company’s broad Phase 2b development of visugromab into randomized Phase 2b studies in select checkpoint naïve frontline and second-line treatment se ..read more

Mabwell, an innovation-driven biopharmaceutical company with entire industry chain, announced that its self-developed novel B7-H3-targeting ADC has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of small cell lung cancer. The FDA grants Orphan Drug Designation to treatments for rare diseases in the United States that affect fewer than 200,000 patients. Orphan Drug Designation offers policy benefits to drug developers, including as aid with medication development, tax credits for a part of clinical trial expenditures, and ..read more

AstraZeneca announced the successful completion of the acquisition of Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The acquisition bolsters the Alexion, AstraZeneca Rare Disease late-stage pipeline and expands on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone (P ..read more

Evotec SE announced it has entered into a multi-year master research collaboration and option and license agreement with Pfizer. Under the agreement, Evotec and Pfizer will initially focus on early discovery research for metabolic and infectious diseases. The research will be carried out at Evotec’s sites in France, including Campus Curie in Toulouse, a state-of-the-art research site with capabilities spanning high throughput screening, in vitro and in vivo biology, proteomics and metabolomics. Evotec will receive research support funding from Pfizer and be eligible for po ..read more