Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Setback For Alembic-backed Rhizen After Concerns Over PI3K Inhibitors

Executive Summary

Disappointment for Alembic-backed Rhizen after partner TG Therapeutics takes Ukoniq off the US market amid wider regulatory scrutiny around the PI3K inhibitor class of drugs. The Indian firm, however, remains upbeat about the US business, which saw significant growth in the fiscal fourth quarter and has15-plus launches lined up.

You may also be interested in...



PI3K Inhibitors: Overall Survival, Adverse Events And Dose Optimization Top US FDA’s Concerns

Agency will ask its Oncologic Drugs Advisory Committee whether future approvals in the class should be supported by randomized data, instead of single-arm studies, given potential overall survival detriment seen in randomized trials to date for four drugs.

TG Shifts Focus To MS After Pausing Oncology Programs, Ukoniq Withdrawal

TG Therapeutics is withdrawing the PI3K-delta inhibitor from the market and halting enrolling in other umbralisib oncology studies to focus attention on ublituximab in relapsing multiple sclerosis.

Ukoniq Lifts Alembic-Backed Rhizen, India Debut On Cards

Rhizen is entitled to royalties on net sales of US FDA-approved Ukoniq, being commercialized by partner TG Therapeutics, and expects to take the lymphoma treatment to India. CEO suggests the first-in-class PI3K/CK1 epsilon inhibitor, discovered by Rhizen, bests competitors including Bayer's Aliqopa.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC146335

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel