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Novo Nordisk A/S (NVO)

NVO on New York Consolidated

43.54USD
27 Jun 2017
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Latest Key Developments (Source: Significant Developments)

Novo Nordisk says trial shows semaglutide helps to lose weight
Friday, 23 Jun 2017 10:45am EDT 

June 23 (Reuters) - Novo Nordisk :Reports up to 13.8% weight loss in people with obesity receiving semaglutide in phase 2 trial.Says in the trial, 957 people with obesity were randomised to treatment with doses of semaglutide between 0.05 to 0.4 mg/day or placebo.Says from a mean baseline weight of around 111 kg and a body mass index of approximately 39 kg/m(2), a weight loss up to 17.8 kg was observed after 52 weeks of treatment with semaglutide.Says this corresponded to an estimated 13.8% weight loss compared to the weight loss of 2.3% achieved by diet, exercise and placebo alone, with all treatment arms adjusted for people discontinuing treatment in the study .Says expects phase 3 programme with semaglutide to begin in 2018.  Full Article

Novo Nordisk: EMA committee issues positive opinion for Victoza label update
Friday, 23 Jun 2017 07:40am EDT 

June 23 (Reuters) - Novo Nordisk A/S :The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive opinion on update of the EU label for Victoza .The update is based on the results from the LEADER trial which investigated the long-term effects of Victoza in people with type 2 diabetes, at high risk of major cardiovascular events.The CHMP positive opinion for Victoza(®) is now referred to the European Commission, which grants approval in the EU, for final action on the proposed indication.Novo Nordisk expects to receive the European Commission decision for the Victoza label update in the third quarter of 2017.  Full Article

Novo Nordisk says announced that CHMP has endorsed an update of EU label for Saxenda
Thursday, 22 Jun 2017 02:20pm EDT 

June 22 (Reuters) - Novo Nordisk :Novo Nordisk says announced that chmp, under european medicines agency , has endorsed an update of eu label for saxenda.Expects feedback from ema on Victoza application shortly.  Full Article

Novo Nordisk submits U.S. application for Tresiba label update
Wednesday, 14 Jun 2017 07:04am EDT 

June 14 (Reuters) - Novo Nordisk A/S :Submits application in the EU for including data from the DEVOTE trial in the Tresiba label.  Full Article

Novo Nordisk says Tresiba showed significant reduction in rates of severe hypoglycaemia compared to insulin glargine
Monday, 12 Jun 2017 05:15pm EDT 

June 12 (Reuters) - Novo Nordisk A/S ::tresiba showed no increased risk of major cardiovascular events and significant reduction in rates of severe hypoglycaemia compared to insulin glargine.Novo Nordisk says trial demonstrated that tresiba met primary endpoint of non-inferiority compared with insulin glargine u100 for major adverse cv events.results from secondary endpoints of trial showed significant reduction in rate of severe and nocturnal severe hypoglycaemia with tresiba versus insulin glargine u100.Novo Nordisk says safety profile of tresiba in devote was generally consistent with previous tresiba clinical trial.  Full Article

Novo Nordisk gets EU approval for haemophilia drug
Tuesday, 6 Jun 2017 10:55am EDT 

June 6 (Reuters) - Novo Nordisk :Says the European Commission has granted marketing authorisation for Refixia for treatment of adolescents and adults with haemophilia B.Says expects to launch Refixia in the first European countries in the fourth quarter of 2017.  Full Article

Innate Pharma acquires anti-c5ar from Novo Nordisk A/S
Friday, 2 Jun 2017 04:27pm EDT 

June 2 (Reuters) - Innate Pharma Sa ::Innate Pharma acquires anti-c5ar, a first-in-class clinical-stage antibody, from Novo Nordisk A/S.Innate Pharma SA - ‍terms of transaction provide for a total upfront payment of EUR 40 million​.Innate Pharma SA- innate pharma intends to start clinical trials with anti-c5ar (iph5401) in oncology in 2018.Innate Pharma SA- acquisition is part of a transaction in which Novo Nordisk A/S will increase its equity stake in Innate Pharma.Innate Pharma SA - ‍total upfront payment of eur 40 million, consists of eur 37.2m to be paid in new innate pharma shares and eur 2.8 million in cash​.Innate Pharma - after issuance of new shares, stake of Novo Nordisk A/S in innate pharma will increase from 10.3% to between 14.6 pct to 15.8 pct.Innate Pharma SA - ‍novo Nordisk A/S will also be eligible for double digit royalties on net sales​.Innate Pharma - ‍novo Nordisk A/S will be eligible for eur 370 million in development, regulatory and sales milestone payments​.  Full Article

Innate Pharma acquires anti-C5aR from Novo Nordisk
Friday, 2 Jun 2017 04:27pm EDT 

June 2 (Reuters) - Innate Pharma Sa :Innate Pharma acquires anti-C5aR, a first-in-class clinical-stage antibody, from Novo Nordisk A/S.Says Innate Pharma intends to start clinical trials with anti-C5aR (iph5401) in oncology in 2018.Says acquisition is part of a transaction in which Novo Nordisk A/S will increase its equity stake in Innate Pharma.Innate Pharma - terms provide for a total upfront payment of EUR 40M, of which EUR 37.2M will be paid in new Innate Pharma shares and EUR 2.8M in cash.Says Novo Nordisk A/S will be eligible for EUR 370M in development, regulatory and sales milestone payments.Says Novo Nordisk A/S will also be eligible for double digit royalties on net sales..  Full Article

Novo Nordisk: Novelion CEO leaves board to avoid potential conflict of interest
Tuesday, 16 May 2017 10:18am EDT 

May 16 (Reuters) - Novo Nordisk ::Says Mary Szela steps down from Novo Nordisk's board of directors with immediate effect."The decision follows changed strategic focus for Novelion Therapeutics, a US-based rare disease company, where Ms Szela serves as CEO, which could lead to a potential conflict of interest".  Full Article

Novo Nordisk renews agreement with NNIT
Friday, 5 May 2017 01:24am EDT 

May 5(Reuters) - NNIT A/S ::SAID ON THURSDAY ENTERED INTO A 6-YEAR-AGREEMENT WITH NOVO NORDISK, REPLACING AN EXISTING CORPORATE CORE IT INFRASTRUCTURE OUTSOURCING CONTRACT .SAID RENEWED CONTRACT WILL TAKE EFFECT FROM JAN. 1, 2017 AND RUN UNTIL DEC. 31, 2022.THE NEW AGREEMENT REPRESENTS A TOTAL VALUE OF AROUND 1 BILLION DANISH CROWNS.THE AGREEMENT INCREASES NNIT'S BACKLOG FOR 2018 AND 2019, BUT DOES NOT CHANGE NNIT'S GUIDANCE FOR 2017 OR THE LONG-TERM TARGETS.  Full Article

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Novo Nordisk says obesity drug helps up to 13.8 percent weight loss in phase 2 trial

COPENHAGEN Danish drugmaker Novo Nordisk said on Friday a phase 2 trial for its big hope in tackling obesity, an improved GLP-1 drug called semaglutide, showed a weight loss of up to 13.8 percent in people with severe conditions.