Industry News

AstraZeneca announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza™ (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).

AbbVie , a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational agent venetoclax in combination with hypomethylating agents (HMAs) for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia (AML) who are ineligible to receive standard induction therapy (high-dose chemotherapy). Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein being developed by AbbVie in partnership with Genentech and Roche.

Exelixis, Inc. announced that the U.S. Food & Drug Administration (FDA) has determined the company’s New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved ZEPATIER™ (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA.

Dr.  Reddy’s Laboratories Ltd. Receives FDA approval for  ZEMBRACE^TM      SymTouch^TM (sumatriptan succinate) Injection for the  acute  treatment of migraines in adults.

Neos Therapeutics, Inc., a pharmaceutical company with a late?stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older.

Biofrontera , the biopharmaceutical company focusing on sun-induced skin cancer, announced recent progress on the ongoing approval process for Ameluz® and BF-RhodoLED® in the USA. FDA has now completed its mid-cycle review of the Ameluz® NDA (new drug application). The review resulted in no additional requests for material nor were any additional review issues highlighted.

Aortica Corporation  announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study sponsored by Dr. Benjamin Starnes – Chief of Vascular Surgery at the University of Washington (UW).  The supplement names Aortica as the supplier of both a Fenestration Alignment Software and a patient-specific 3-D printed fenestration template.