September 2016

BrainScope Company, Inc. announced that the United States Food and Drug  Administration (FDA) has cleared the company to market the Ahead 300, its most  advanced medical device for use in assessing traumatic brain injury (TBI). Developed in  partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal  device of clinically relevant measures, offering clinicians a comprehensive panel of data  to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead  300 represents an evolution from the three BrainScope products that have previously  received FDA clearance, and with its substantial additional capabilities, will be the first  product the company will sell commercially. 

Pain Therapeutics, Inc.  announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for REMOXY ER (oxycodone capsules CII).  The CRL informs that REMOXY ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.

Janssen Research & Development, LLC announced that a supplemental New Drug  Application (sNDA) for ibrutinib (IMBRUVICA ® ) has been submitted to the U.S. Food and  Drug Administration (FDA) for the treatment of patients with marginal zone lymphoma  (MZL) who require systemic therapy. The filing is based on data from the multi-center, open-  label Phase 2 PCYC-1121 trial assessing the use of ibrutinib, a BTK inhibitor, in patients  with MZL who have received at least one prior therapy.

Janssen Biotech, Inc., announced that the U.S. Food and Drug Administration (FDA) has  approved STELARA ® (ustekinumab) for the treatment of moderately to severely active  Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment  with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis  factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF  blockers. STELARA ® is the first biologic therapy for Crohn’s disease targeting interleukin  (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses.