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...
treatment News
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...
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...
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...
San Diego, Calif. – The American Association for Cancer Research’s annual conference kicks off Friday as more than 20,000 attendees descend on San Diego. Analysts and researchers who spoke with BioSpace said they’re looking forward to early scientific data, and antibody-drug conjugates (ADCs) will be a key focus. Stay tuned to...
Basel, Switzerland – The past two years have seen a pair of new treatments approved for a particularly intractable neurodegenerative disease—amyotrophic lateral sclerosis. But while Amylyx’s Relyvrio and Biogen’s Qalsody have crossed the FDA finish line, others have stumbled in a regulatory space that experts say is still evolving. The...
NEW HAVEN, Conn. — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced the completion of patient enrollment in the safety lead-in portion of the investigator-sponsored Phase 2 trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) in previously treated metastatic...
NEW HAVEN, Conn. — BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 17/496,470 with claims pertaining to a method of treating agitation in patients...