Pharma News

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.

Researchers have found that a protein involved in the breakdown of glucose a process known as glycolysis plays an important role in coordinating cellular processes crucial to cancer metabolism and brain tumour formation.

Researchers have identified a brain inflammation marker in patients at early asymptomatic stages of Alzheimer's disease.This molecule may provide clinicians with a rapidly detectable biomarker for the transition from preclinical Alzheimer's disease to cognitive impairment and progression to full dementia.

Scientists have discovered a new kind of stem cell one that could lead to advances in regenerative medicine as well as offer new ways to study birth defects and other reproductive problems.

The World Health Organization has set up a Newborn and Birth Defect Surveillance network, a initiative to keep a track of newborns with defects across the globe.

The CPI-M on Thursday expressed deep concern that 76 life saving drugs have been taken off the customs duties exemption list and urged the government to review the decision.

Researchers, including one of Indian-origin, have shown that a next-generation cell-based immunotherapy may offer new hope in the fight against the most aggressive form of brain cancer called glioma.

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.

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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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).