Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Y-mAbs Faces Delay In Pediatric Neuroblastoma With Refuse-To-File Letter

Executive Summary

Omburtamab, for CNS metastases resulting from neuroblastoma, needs more clinical and CMC data for its rolling BLA to be reviewed. The company says timelines for lead candidate naxitamab should not be affected.

You may also be interested in...



Roche’s Novel Ranibizumab Implant Among Myriad New Filings In EU

The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.

Deal Watch: GSK Makes $85m Wager On Surface’s Preclinical NK Cell Therapy

Although SRF813 isn’t likely to reach the clinic until 2021, GSK likes cell therapy’s monotherapy and combination potential. Lilly bids $880m to acquire neurodegenerative cell therapy firm Prevail.

12 Approvals To Look Out For In Q4

The end of the year should see a flurry of new products reaching the market to break new commercial ground or shake up their respective therapeutic areas. Here, Scrip takes a look at 12 of the more interesting approvals expected in the coming months, with the help of analysts at Biomedtracker.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC143085

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