Gilead Company Kite Says FDA Oks RVV Manufacturing Facility In California For Commercial Production

RTTNews | 594 days ago
Gilead Company Kite Says FDA Oks RVV Manufacturing Facility In California For Commercial Production

(RTTNews) - Biopharmaceutical company Kite, a Gilead Sciences, Inc. (GILD) company, announced Monday that the U.S. Food and Drug Administration (FDA) has approved the company's retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production.

Viral vectors are key components needed to manufacture Kite's cell therapies to treat certain blood cancers. Kite is the only cell therapy company with in-house commercial and clinical trial viral vector manufacturing capabilities, augmenting its strong external supply partners.

The viral vector facility further strengthens the vertical integration of Kite's global CAR T-cell Therapy manufacturing network. CAR T-cell therapies are one-time treatments individually made starting from a patient's own white blood cells, called T-cells.

The Oceanside site is part of Kite's global commercial manufacturing network that includes facilities in El Segundo, California, Amsterdam, Netherlands, and a recently FDA-approved Maryland site.

For More Such Health News, visit rttnews.com

read more
Gilead Sciences Says FDA OK's Updated Label Of Biktarvy To Treat Pregnant People With HIV-1

Gilead Sciences Says FDA OK's Updated Label Of Biktarvy To Treat Pregnant People With HIV-1

Gilead Sciences, Inc. (GILD) announced Friday the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads.
RTTNews | 23 days ago
Gilead Sciences Says CHMP Adopts Positive Opinion To Extend Indication Of Veklury

Gilead Sciences Says CHMP Adopts Positive Opinion To Extend Indication Of Veklury

Gilead Sciences, Inc. (GILD) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 as well as pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).
RTTNews | 611 days ago
TSX Ends Notably Higher, Gains 0.7% In Week

TSX Ends Notably Higher, Gains 0.7% In Week

The Canadian market ended on a firm note on Friday, lifted by strong gains in materials and energy sectors as commodity prices climbed higher amid rate cut bets and optimism about outlook for demand.
RTTNews | 1 day ago
Dollar Retreats After Early Gains

Dollar Retreats After Early Gains

The U.S. dollar climbed higher in the European session on Friday, extending gains from the previous session, but retreated later and stayed somewhat subdued thereafter and shed ground against its counterparts amid bets the Federal Reserve will start cutting interest rates from September.
RTTNews | 1 day ago