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- Read more about Sobi Get Health Canada approval for Orfadin capsules for hereditary tyrosinaemia type-1
Sobi Canada Inc., a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi), announced that Health Canada has approved Orfadin (nitisinone) capsules for the treatment of hereditary tyrosinaemia type-1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver, brain and kidney complications and can be fatal if untreated.

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- Read more about Senhwa Biosciences' CX-4945 get Orphan Drug status by US FDA
Senhwa Biosciences, Inc. announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to CX-4945 for the treatment of cholangiocarcinoma.
- Read more about FDA Grants Orphan Drug Designation To ALXN1210 For Patients With PNH
Alexion Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting anti-C5 antibody that inhibits terminal complement, which is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a debilitating, ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in hemolysis (destruction of a patient’s red blood cells).
- Read more about Adamas’ ADS-5102 NDAaccepted by U.S. FDA
Adamas Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. The ADS-5102 application has been given a Prescription Drug User Fee Act (PDUFA) target action date of August 24, 2017.
- Read more about MTaI Committed to Fair & Transparent Mechanism of Stent Pricing that Accounts for the Innovative Nature of MedTech Sector
The Medical Technology Association of India (MTaI) has been proactively and collaboratively working with the authorities in the process on pricing discussions over the past many months. We are committed to have a fair and transparent mechanism of pricing which accounts for the innovative nature of the sector.
- Read more about Sun Pharma's Seciera meets primary & secondary endpoints in phase 3 study
Sun Pharma announced successful phase 3 confirmatory clinical trial results for Seciera (cyclosporine A, 0.09% ophthalmic solution), for the treatment of dry eye disease. Seciera is a patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09%. It is a clear, preservative-free, aqueous solution. Seciera is being developed by Ocular Technologies, a company recently acquired by Sun Pharma. Following this acquisition, Sun Pharma owns exclusive, worldwide rights to Seciera and is developing it to commercialize for global markets including US, Europe, and Japan, as well as several emerging markets.
- Read more about Kalobios’ Benznidazole get Positive Guidance From FDA
KaloBios Pharmaceuticals, Inc. announced positive guidance in the minutes from a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the development plans for benznidazole for the treatment of Chagas disease, a neglected tropical disease.
- Read more about Elanco completes acquisition of Boehringer Ingelheim Vetmedica's US feline, canine & rabies vaccines portfolio
Elanco US Inc., a subsidiary of Eli Lilly and Company, has completed the acquisition of Boehringer Ingelheim Vetmedica, Inc's (BIVI) US feline, canine and rabies vaccines portfolio - as well as a fully integrated manufacturing and R&D site and several pipeline assets.
- Read more about Cesca Announces FDA Approval Of IDE Supplement For Phase III Clinical Trial
Cesca Therapeutics Inc. announced that the Company received approval from the U.S. Food and Drug Administration (FDA) for significant revisions to the Company’s pivotal study for treatment of Critical Limb Ischemia (CLI). The CLI clinical trial is designed to demonstrate the safety and efficacy of the Company’s point-of-care SurgWerks™ system for the treatment of CLI patients with limited or no treatment options. The study was first approved by FDA in June 2015, but was not initiated at that time pending funding.
- Read more about PharmaCyte Biotech Declare Pre-IND Meeting Date with FDA
PharmaCyte Biotech, Inc., a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it will be meeting with the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) on Tuesday, January 17, 2017. The meeting is to discuss numerous aspects of PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).