Pharma News

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- Read more about Sun Pharma receives US FDA approval for generic Glumetza
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.
- Read more about REGENXBIO's RGX-121 Gene Therapy receive Rare Pediatric Disease Designation by FDA
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).
- Read more about Pluristem Receives Positive Feedback from FDA for Phase III Trial of PLX-PAD in CLI
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).
- Read more about Teva completes acquisition of Actavis Generics
(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.
- Read more about New Indian FDI policy permits higher investment chances in Pharmaceuticals
Foreign Direct Investment (FDI) in Brownfield pharma sector has been permitted upto 74% under automatic route; and FDI beyond 74% and upto 100% is allowed under Government approval route.
- Read more about Lupin acquires 21 products from japan based Shionogi
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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- Read more about KCDA and Lupin penalised by CCI on anticompetitive conduct
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.
- Read more about Vanda Pharma launches Hetlioz in Germany
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.
- Read more about Vaccinex Receives FDA Fast Track Designation for VX15 Antibody for Huntington’s Disease
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).
- Read more about US FDA approves Shire's Adynovate with Baxject III reconstitution system
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].