Pharma News

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).

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.

El Nino, the climate cycle that develops along the tropical west coast of South America every 3 to 7 years, could be transporting cholera-like diseases through bacteria that thrive in seawater, a study said.

People who exercise regularly over several years were less than half as likely to become depressed after a heart attack than those who never exercised, finds a new study.