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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The Competition Commission of India (Commission) has found the Karnataka Chemists and Druggist Association (KCDA) and Lupin Ltd. (Lupin) to be in contravention of the provisions of the Competition Act, 2002 (the Act). In a case filed by M/s Maruti & Co., it was brought to the notice of the Commission that KCDA restraints pharmaceutical companies from appointing new stockists in the State of Karnataka unless a No Objection Certificate (NOC) is obtained from it.
Vanda Pharmaceuticals Inc. (Vanda), a specialty pharmaceutical company, announced that Hetlioz (tasimelteon) is now available for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in Germany.
Vaccinex, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VX15 as a potential treatment for Huntington’s disease (HD).
Shire plc, a leading global biotechnology company, announced that the US Food and Drug Administration (FDA) has approved the Baxject III reconstitution system for Adynovate [Antihemophilic Factor, (Recombinant), PEGylated].
Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved Dysport® (abobotulinumtoxinA) for injection for the treatment of pediatric lower limb (PLL) spasticity in children two years of age and older.
Shire plc announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. Shire is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT), a protein which is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a serious, chronic liver disease for which there are currently no approved drugs.
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