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...
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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...
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...
Washington, DC – As the oncology space moves away from single oncogene-targeted treatments, immunotherapies that aim to prevent immune fatigue and enhance immune cell engagement are emerging as promising therapeutic trends, experts told BioSpace. But these therapies are not always intended to be deployed on their own. Increasingly, scientists and...
Washington, DC – Advances in antibody-drug conjugates, including novel payloads and new targets, will be featured at the American Association for Cancer Research’s annual conference, taking place this week in San Diego, where companies, including Elevation Oncology and Tubulis, will present new data from their respective programs. The first antibody-drug...
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...