Industry News

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. 

Leading the way in becoming an inspirational model for pharmaceutical sector, Gujarat has evolved into a hub for major pharmaceutical companies. Many investment-friendly initiatives and growth propelling policies in industries such as pharmaceutical & biotechnology, textile, auto, gems & jewellery, IT, maritime & port and engineering are significantly driving growth for the state.

Marksans Pharma Limited announces that USFDA has granted approval for an Abbreviated New Drug Application (ANDA) for Loratadine Liquid Filled Capsules 10 mg.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. AMJEVITA is Amgen's first biosimilar to receive regulatory approval.

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Allergan plc announced the company has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® Cohesive breast implants, offering women undergoing reconstruction, augmentation or revision surgery a new breast shaping option that combines a high gel fill ratio and Allergan's highly cohesive gel for a customized result. The new NATRELLE INSPIRA® Cohesive line of breast implants is the newest entry into the category of breast implants commonly referred to  as "gummy" implants, designed for women who are interested in increased breast fullness.

Allergan plc and Adamas Pharmaceuticals, Inc announced that all four dosage strengths of NAMZARIC® (memantine and donepezil hydrochlorides) extended-release capsules that allow patients on donepezil 10 mg to start directly on NAMZARIC are now available by prescription in pharmacies throughout the U.S. NAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI) for the treatment of moderate to severe Alzheimer's Disease in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC'S new indication and dosage strengths were approved by the U.S. Food and Drug Administration (FDA) in July 2016.