USFDA

Vertex Pharmaceuticals Incorporated, a global biotechnology company, announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of Orkambi (lumacaftor/ivacaftor) in people with cystic fibrosis (CF) ages 6 to 11 who have two copies of the F508del mutation. The FDA granted Vertex's request for Priority Review of this sNDA, and a target review date of September 30, 2016 was set under the Prescription Drug User Fee Act (PDUFA).

Strides Shasun Limited has received the first to file tentative approval from the United States Food & Drug Administration (USFDA) for Roflumilast tablets, 500 mcg. The product received approval in 15 months under the new the Generic Drug User Fee Amendments of 2012 (GDUFA) goal date regime. The product can be launched earliest by January 2020.

BioVentrix Inc., an emerging medical device company for less invasive treatment of heart failure (HF), announced that it has received a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial, named ALIVE (American Less Invasive Ventricular Enhancement). The trial is designed to demonstrate the safety and effectiveness of the Revivent TC TransCatheter; a hybrid closed-chest transcatheter procedure to treat patients suffering from ischemic cardiomyopathy by reshaping and restoring the left ventricle (LV).  This is accomplished by implanting micro-anchoring pairs in the LV to exclude scarred myocardium from the healthy tissue.

CordenPharma International would like to notify customers about a warning letter received from the USFDA on May 24, 2016 in its CordenPharma Latina facility in Sermoneta, Italy. This action follows an earlier inspection of the site by the agency in May 2015.

One of India’s largest sterile Injectables company, Claris Lifesciences Limited (Claris/Company), announced today that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA has concluded that the inspection stands closed and the facility was found to be acceptable.

AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.

The U.S. Food and Drug Administration (FDA) approved ZINBRYTATM (daclizumab), a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS), Biogen and Abbvie announced. Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis (MS).

The U.S. Food and Drug Administration approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Axumin is marketed by Blue Earth Diagnostics, Ltd., Oxford, United Kingdom

Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.

Novavax, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’ RSV F-Protein nanoparticle vaccine candidate (RSV F Vaccine) for the protection of older adults (60 years of age and older).