20:16 , Feb 23, 2018 |  BC Week In Review  |  Company News

Novo launches Ozempic and Fiasp in U.S.

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) launched in the U.S. Ozempic semaglutide (NN9535) to treat Type II diabetes in adults and Fiasp rapid-acting insulin (NN1218) analog to improve glycemic control in adults with Type I and...
00:28 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

FDA approves Novo's fast-acting insulin aspart for diabetes

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) said FDA approved Fiasp fast-acting insulin aspart (NN1218) to treat Type I and II diabetes. In April, Novo resubmitted an NDA to FDA for the product after FDA issued a...
06:12 , Jul 28, 2017 |  BC Week In Review  |  Clinical News

Adocia begins head-to-head trial of BioChaperone Lispro vs. Fiasp and Novolog

In early June, Adocia S.A. (Euronext:ADOC) began a 3-way crossover Phase II trial to compare single subcutaneous doses of 0.15 U/kg BioChaperone Lispro vs. 0.15 U/kg Fiasp ( faster-acting insulin aspart , NN1218) or 0.15...
19:42 , Apr 7, 2017 |  BC Week In Review  |  Clinical News

Fast-acting insulin aspart regulatory update

Novo Nordisk resubmitted an NDA to FDA for fast-acting insulin aspart to treat Type I and II diabetes. Novo expects to receive feedback from the agency in 4Q17. Last year, FDA issued a complete response...
00:41 , Mar 25, 2017 |  BioCentury  |  Strategy

Mountain climbing

U.S. pricing pressure on insulin and hemophilia products have caused Novo Nordisk A/S to guide for negative sales and operating profit growth for the first time ever. While newly launched diabetes and obesity products are...
20:51 , Jan 13, 2017 |  BC Week In Review  |  Clinical News

Fiasp regulatory update

The European Commission approved Fiasp insulin aspart from Novo Nordisk to treat diabetes in adults. Novo Nordisk plans to launch Fiasp, a faster-acting insulin aspart formulation, in Europe this half. Last year, FDA issued a...
14:33 , Nov 17, 2016 |  BC Week In Review  |  Clinical News

Fiasp regulatory update

EMA's CHMP recommended approval of Fiasp insulin aspart from Novo Nordisk to treat diabetes in adults. The company expects a decision from the European Commission in 1Q17. Fiasp is a faster-acting insulin aspart formulation. Last...
23:29 , Nov 11, 2016 |  BC Extra  |  Company News

CHMP recommendations include HBV drug Vemlidy

EMA's CHMP backed approval of a host of candidates on Friday, including Vemlidy tenofovir alafenamide fumarate (TAF; GS-7340 ) from Gilead Sciences Inc. (NASDAQ:GILD) to treat HBV. CHMP recommended Vemlidy's approval to treat chronic HBV...
07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

Faster-acting insulin aspart regulatory update

FDA issued a complete response letter to Novo Nordisk for faster-acting insulin aspart to treat Type I and II diabetes. According to Novo Nordisk, FDA requested additional immunogenicity and clinical pharmacology data. The product is...
07:00 , Aug 1, 2016 |  BC Week In Review  |  Clinical News

Faster-acting insulin aspart: Phase IIIa data

Top-line data from the double-blind, international Phase IIIa onset 1 trial in 1,143 Type I diabetics showed that subcutaneous FIAsp dosed at mealtime plus basal insulin met the primary endpoint of reducing HbA1c from baseline...