Medtech Insight 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


Nycomed Amersham's Sonazoid

This article was originally published in The Gray Sheet

Executive Summary

New drug application is submitted for the ultrasound contrast agent. Based on results with 1,300 patients in Europe and the U.S., the NDA includes clinical data "demonstrating echocardiographic improvement in endocardial border delineation and left ventricular opacification following administration" of the drug, the firm says Aug. 6. On Aug. 3, FDA approved Diatide's NDA for the lung cancer detection agent NeoTect, which Nycomed Amersham is co-promoting in the U.S. (1see related story, p. 10)

You may also be interested in...

Diatide NeoTect Future Indications Will Be Evaluated Off-Label

Diatide says that a $2 mil. milestone payment from marketing partner Nycomed Amersham triggered by FDA's Aug. 3 approval of NeoTect will be used in part to bolster its own marketing efforts for the lung cancer imaging agent.

Finance Watch: Silverback, Kinnate, Sigilon Launch December’s First IPOs

Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.

BioCryst’s Oral Option To Take On Injectables In HAE Prophylaxis Market

Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.




Ask The Analyst

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

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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