To Our New Jersey Life Sciences Community:
Welcome to another edition of the Weekender.
New Jersey Companies Continue Progress in Drug Development
Edge Therapeutics, a BioNJ Member located in Berkeley Heights, announced that the U.S. Food and Drug Administration has granted orphan drug designation to EG-1962, the Company’s lead product candidate, which is in clinical trials treating patients that have suffered an aneurysmal subarachnoid hemorrhage (aSAH), also known as a ruptured brain aneurysm.
Advaxis, Inc., a BioNJ Member located in Princeton, announced clearance of the Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to conduct a Phase 2 study of ADXS-HPV (ADXS11-001) alone or in combination with Incyte Corporation’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), for the treatment of Stage I-IIIb human papillomavirus (HPV)-associated cervical cancer.
Merck, a BioNJ Member located in Kenilworth, announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection.
Amicus Therapeutics, a BioNJ Member located in Cranbury, has submitted a marketing authorization application (MAA) to request full approval of the oral small molecule pharmacological chaperone Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. The brand name Galafold has been approved by both the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA).
New Jersey’s Life Sciences Ecosystem in the Spotlight
As you peruse this week’s edition of the Weekender, make sure to read all of the wonderful stories featuring New Jersey’s vibrant life sciences community and the role we are playing at BIO 2015. If you are not registered for the industry’s largest event of the year, please do so today.
Click here for this week’s Weekender.