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Rhizen Pharmaceuticals AG, a clinical-stage, oncology-focused biopharma company, with 50% stake owned by Alembic Pharmaceuticals and the rest by its Indian CEO Swaroop Vakkalanka, has announced that its novel, next generation PI3K-delta inhibitor Umbralisib (Ukoniq) has secured U.S. FDA accelerated approval for the treatment of blood cancer.
The drug, which has been licensed to TG Therapeutics since 2012, has bagged the approval for the U.S. market. TG Therapeutics has the global license except for the Indian market which will be handled by Rhizen and Alembic.
The drug is for treatment is of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.
With five observations Alembic Pharmaceuticals announced that United States Food and Drug Administration (USFDA)
has conducted an inspection at Alembic Pharmaceuticals New Injectable Facility
(F-3) located at Karkhadi from 29 January 2021 to 5 February 2021. This was a
scheduled inspection and at the end of the inspection, the USFDA issued a Form 483
with 5 observations.
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Investors with a short term perspective can buy the stock of Alembic at current levels. The stock had encountered key resistance at around ₹120 in mid-September 2020 and was on a medium-term downtrend