IRVINE, Calif. – Bioniz Therapeutics, Inc., (“Bioniz”), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine inhibitors for the treatment of cancer and autoimmune diseases, today announced the European Commission (EC) has granted orphan designation to BNZ-1 for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer....
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MAINZ, Germany and SHANGHAI, China – BioNTech SE (Nasdaq: BNTX) and Duality Biologics (Suzhou) Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for BNT325/DB-1305 for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who...
VANCOUVER, BC – BioNxt Solutions Inc. is pleased to report that the comparative pharmacokinetic (PK) study for its oral dissolvable film (ODF) based proprietary Cladribine product for the treatment of Multiple Sclerosis (MS) has been completed. Results will be reported by the Company when available. The PK study closely follows...
PARIS – The European Medicines Agency has issued a marketing authorisation for OZAWADE™ (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea in adults. OZAWADE™ is indicated to improve wakefulness and reduce EDS in adult patients suffering from obstructive sleep apnoea (OSA) whose EDS...
Paris — The European Medicines Agency has just granted an extension of the indication for the marketing authorisation for WAKIX® (pitolisant), which is now indicated for the treatment of narcolepsy in children from the age of 6 years, with or without cataplexy. Narcolepsy is a rare disease, which originates in...
MIAMI – Biorasi, a leading global full-service contract research organization (CRO), has announced the appointment of Jimmy El Hokayem, Ph.D., head of the company’s Neurology and Regenerative Medicine Center of Excellence to the Scientific Advisory Board (SAB) for the Foundation for Angelman Syndrome Therapeutics (FAST). In this role, Dr. El Hokayem...
Washington, DC – In 2023, cell and gene therapy saw an unprecedented surge with seven FDA approvals, and this year, an even greater number of these treatments could reach the market. So far in 2024, the regulator has given the green light to three new CGTs, and at least seven...
Washington, DC – The March approval of ITF Therapeutics’ Duvyzat marked the third new FDA-approved treatment in 10 months for Duchenne muscular dystrophy (DMD), a genetic disorder that causes progressive muscle weakness and degeneration. In June 2023, the regulator greenlit Sarepta’s Elevidys as the first-ever gene therapy for DMD. That...
Basel, Switzerland – Novartis on Saturday posted two promising Phase III readouts in rare kidney diseases, setting the pharma up for two potential approvals in the space. The company presented these data at the European Renal Association Congress over the weekend. Results from the Phase III ALIGN study showed that...
Washinton, DC – On March 15, the FDA’s Oncologic Drugs Advisory Committee will meet to discuss two CAR T cell therapies for multiple myeloma—Abecma, from Bristol Myers Squibb and 2seventy bio, and Carvykti, from Johnson & Johnson and Legend Biotech. Both treatments are currently approved for the treatment of adults...