Pharma News

 Luminex Corporation announced that it has received FDA clearance for the ARIES® Flu A/B & RSV Assay. This is the second assay the FDA has cleared for use on the Luminex ARIES® System.

Sorrento Therapeutics, Inc. an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, announced  that it has entered into a binding term sheet to create a joint venture  ("JV") with CHA Biotech Co. , LTD, of South Korea to develop and commercialize proprietary Chimeric Antigen Receptor ("CAR") modified cellular therapies based on CBT's Activated Killer Cell ("AKC") technology and five of  Sorrento's CARs for all disease conditions, including oncology and infectious diseases. The JV covers products on a global basis with the exception of the Greater Chinese market. 

Sun Pharma has announced that one of its subsidiaries has received final approval from US  FDA for its Abbreviated New Drug Application (ANDA) for generic version of Glumetza,  metformin hydrochloride extended release tablets 500 mg and 1000 mg. 

REGENXBIO Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to RGX-121, REGENXBIO’s investigational gene therapy product candidate for the treatment of Mucopolysaccharidosis Type II (MPS II).

Pluristem Therapeutics Inc.announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed Phase III trial of its PLX-PAD cells in the treatment of critical limb ischemia (CLI). This Phase III trial is intended to support a biologics license application (BLA). 

(BUSINESS WIRE) This strategic acquisition brings together two leading generics businesses with complementary strengths, R&D capabilities, product pipelines and portfolios, geographical footprints, operational networks and cultures.

Lupin's Japanese subsidiary Kyowa Pharmaceutical Industry Co., Ltd. has entered into a strategic asset purchase agreement with Shionogi & Co., Ltd.  on August 1, 2016, to acquire 21 long-listed products from the Japanese pharma major, effective December 1, 2016, subject to certain closing conditions and regulatory approvals including the transfer of marketing authorization of the products to Kyowa.

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