Industry News

- Read more about BioMarin receives Orphan Drug Designation from FDA for BMN 270
BioMarin Pharmaceutical Inc. Announced that BMN 270, an investigational gene therapy for the treatment of patients with hemophilia A, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). BioMarin is currently conducting a Phase 1/2 study to evaluate the safety and efficacy of BMN 270 gene therapy in up to 12 patients with severe hemophilia A and will provide a program update in April. BMN 270 is an AAV 5 factor VIII vector, designed to restore factor VIII plasma concentrations, essential for blood clotting in patients with hemophilia A.

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- Read more about Edwards SAPIEN XT Valve receives FDA approval for Pulmonic Procedures
Edwards Lifesciences Corporation announced U.S. Food and Drug Administration approval to expand use of the Edwards SAPIEN XT transcatheter heart valve for pulmonic valve replacement procedures.
- Read more about FDA approves Roche’s Gazyva (obinutuzumab)
Roche announced that the US Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan® (rituximab)-containing regimen, or had their follicular lymphoma return after such treatment. Follicular lymphoma is the most common type of indolent (slow-growing) non-Hodgkin lymphoma (NHL) and accounts for approximately one in five cases of NHL.
- Read more about Abeona Therapeutics Announces FDA Allowance of IND for Systemic AAV Phase 1/2 Clinical Study With ABO-102 Gene Therapy
Abeona Therapeutics, Inc. announced the FDA cleared the Company's Investigational New Drug Application for ABO-102 (AAV- SGSH), a single treatment strategy for Mucopolysaccharidosis Type IIIA (MPS IIIA). The ABO-102 IND application is now active and enables Nationwide Children's Hospital (Columbus, OH) to initiate a Phase 1/2 clinical study designed to assess the safety, tolerability and potential efficacy of ABO-102 in children with MPS IIII A.
- Read more about Amgen Submits Supplemental BLA For BLINCYTO® (Blinatumomab)
Amgen announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). BLINCYTO, the first-and-only FDA-approved bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy, is currently available under an accelerated approval in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow impacting both adults and children.

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- Read more about Aurinia receives Fda fast track designation for Voclosporin
Aurinia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for voclosporin, the Company’s next generation calcineurin inhibitor, for the treatment of Lupus Nephritis (LN).
- Read more about U.S. FDA Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Odefsey is Gilead’s second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV.
- Read more about Zydus Cadila received USFDA nod for Glyburide and Metformin
Zydus Cadila has received the final approval from the USFDA to market Glyburide and Metformin Hcl Tablets USP in strengths of 1.25/250, 2.5/500 and 5/500 mg.
- Read more about Infosys offers healthcare analytics on Microsoft cloud
Software major Infosys on Tuesday announced tying up with Microsoft to offer healthcare analytics, using the latter's cloud platform.
- Read more about AstraZeneca enters licensing agreement with China Medical System Holdings
AstraZeneca announced it has entered into a licensing agreement with China Medical System Holdings Ltd (CMS) for the commercialisation rights in China to its calcium channel blocker, Plendil (felodipine). Plendil was first approved in China in 1995 for the treatment of hypertension or high blood pressure and in 2015 achieved Product Sales of $189 million.