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Umbralisib (UKONIQ) granted accelerated approval by US FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL), follicular lymphoma (FL).
Umbralisib, a novel next generation inhibitor of PI3K delta CK1 epsilon, was discovered by Rhizen Pharmaceuticals and subsequently licensed to TG Therapeutics, who led the asset s clinical development.
Rhizen and its affiliate Alembic Pharma to support TG Therapeutics towards UKONIQ s commercialization as its manufacturing supply partner; Rhizen plans to register and commercialize Umbralisib in India.
Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, today announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ:TGTX), has secured US FDA accelerated approval for the treatment of:
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Glenmark Pharmaceuticals receives ANDA approval for Topiramate Extended-Release Capsules
Posted On: 2021-02-02 20:38:31 (Time Zone: Arizona, USA)
Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, the generic version of Qudexy® XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher-Smith Laboratories, LLC.
According to IQVIA™ sales data for the 12 month period ending December 2020, the Qudexy® XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg market achieved annual sales of approximately $120.8 million .
Glenmark s current portfolio consists of 169 products authorized for distribution in the U.S. marketplace and 43 ANDA s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accel
The government has started sending Covid-19 vaccine doses across the country from Dhaka ahead of the mass inoculation campaign set to begin from February 7.
As of yesterday, 36 districts have received the vaccine according to a list prepared by the government, said officials, adding that vaccines will reach all 64 districts of the country by tomorrow.
Beximco Pharmaceuticals Limited, the local agent of Serum Institute of India (SII), has been transporting vaccines to the districts as per the agreement with the government.
Bangladesh has purchased three crore doses of Oxford-AstraZeneca vaccine from SII, 50 lakh doses of which arrived in Dhaka on January 25. Besides, the country has received 20 lakh doses of the same vaccine from the Indian government as a gift on January 21.
Glenmark Pharmaceuticals receives ANDA approval for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg
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MUMBAI, India, Jan. 28, 2021 /PRNewswire/ Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo®
1 Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.
According to IQVIA
TM sales data for the 12 month period ending November 2020, the Evekeo® Tablets, 5 mg and 10 mg market
2 achieved annual sales of approximately $21.5 million .
Glenmark s current portfolio consists of 168 products authorized for distribution in the U.S. marketplace and 43 ANDA s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.