June 2016

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.

Dr Reddy’s Laboratories, a Rs.15,800 crore plus second largest pharma company in India, announced that its US subsidiary, Promius Pharma, LLC, U.S., launched Sernivo (betamethasone dipropionate) spray, 0.05% in the US. Sernivo spray, a prescription topical steroid approved by the Food and Drug Administration (FDA) in February of 2016, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Jazz Pharmaceuticals plc, an international biopharmaceutical company, and Celator Pharmaceuticals, Inc., an oncology-focused biopharmaceutical company, have entered into a definitive agreement for Jazz Pharmaceuticals to acquire Celator for $30.25 per share in cash, or approximately $1.5 billion.

Teva Pharmaceutical Industries Ltd. announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD). This is the first deuterated product to be reviewed by the FDA. The FDA has asked Teva to examine blood levels of certain metabolites. These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine. No new clinical trials have been requested.

Indivior Inc., a subsidiary of Indivior PLC announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.

Roche announced that it has launched the CoaguChek® INRange system in countries. The CoaguChek INRange system is the first Bluetooth enabled PT/INR home health device that helps patients and their healthcare providers (HCPs) have greater control over their coagulation status and the ability to monitor Vitamin K Antagonist (VKA) therapy.

Takeda Pharmaceutical Company Limited, a global, R&D-driven pharmaceutical company, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the current conditional approval of Adcetris (brentuximab vedotin) and recommended its approval for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT).

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.