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Novo Nordisk A/S (NVO.N)

NVO.N on New York Stock Exchange

21 Apr 2017
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Latest Key Developments (Source: Significant Developments)

Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the U.S
Wednesday, 29 Mar 2017 10:51am EDT 

Novo Nordisk : Says has resubmitted the new drug application (NDA) for fast-acting insulin aspart as a class II re-submission to the United States Food and Drug Administration (FDA) . Says FDA requested in October additional information related to the assay for the immunogenicity and the assay used to generate the clinical pharmacokinetics data before the review of the NDA could be completed . Says has now evaluated the content of the Complete Response Letter and completed the End-of-Review meeting with FDA .Says expects to receive feedback from FDA in last quarter of 2017.  Full Article

Novo Nordisk launches Fiasp-drug in Canada
Monday, 27 Mar 2017 02:54am EDT 

Novo Nordisk : Says Fiasp, a new, fast-acting mealtime insulin for the treatmentof diabetes in adults, has been launched in Canada on Monday Further company coverage: [NOVOb.CO] (Reporting by Stine Jacobsen) ((stine.jacobsen@thomsonreuters.com;)).  Full Article

EU recommends approval of Novo Nordisk's haemophilia drug
Friday, 24 Mar 2017 08:15am EDT 

EU Medicines Agency: EU Medicines Agency recommendations for March 2017 . Recommends approval of Novo Nordisk's Nonacog Beta Pegol drug for treatment of haemophilia . Recommends approval of Pfizer's Trumenba drug for prophylaxis against invasive meningococcal disease Link to press release: (http://bit.ly/2nv0UIk) Further company coverage: [NOVOB.CO] (Bengaluru Newsroom: +91 806 749 1136).  Full Article

Novo Nordisk gets positive opinion for label update in EU for Tresiba
Friday, 24 Mar 2017 07:30am EDT 

Novo Nordisk : The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive opinion, recommending an update of the label for Tresiba (insulin degludec) to include data from the SWITCH 1 and 2 clinical trials . In the trials, Tresiba, the new-generation once-daily basal insulin, demonstrated clinically relevant reductions in hypoglycaemia compared with insulin glargine U100 in people with type 1 and type 2 diabetes . For the SWITCH 1 trial, the CHMP recommends the updated label to include results reflecting the significant reductions in hypoglycaemia . For the SWITCH 2 trial, the CHMP recommends the updated label to include results reflecting the significant reductions in hypoglycaemia . "An inclusion of the SWITCH trial results in the label will further support the clinical profile of Tresiba," said Mads Krogsgaard Thomsen, chief science officer . The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the EU .Novo Nordisk expects to receive the updated marketing authorisation in the second quarter of 2017.  Full Article

Dong Energy to build biogas plant for Novo Nordisk, Novozymes residues
Thursday, 23 Mar 2017 04:18am EDT 

Dong Energy : Says will in cooperation with Bigadan build a large-scale biogas plant . The plant will reuse residues from production facilities of Novozymes and Novo Nordisk in Kalundborg, Denmark . Construction of the new biogas plant will commence in March 2017, and the plant is scheduled for commissioning already in the spring of 2018 .The biogas plant will have a production capacity of 8 million square metres of natural gas per year, corresponding to the consumption of around 5,000 households.  Full Article

Novo A/S has no plans to buy more Evotec shares
Wednesday, 15 Mar 2017 12:06pm EDT 

Evotec AG : Novo A/S does not intend to obtain further voting rights by acquisition or any other way . Novo A/S does not intend to influence composition of issuers' administration, management or supervisory board . Novo A/S does not intend to change capital structure of evotec, especially with regards to ratio of internal/outside financing and dividend policy Further company coverage: [EVTG.DE] ((frankfurt.newsroom@thomsonreuters.com; +49 69 7565 1270;)).  Full Article

BRIEF-Riis says to head Falck after leaving Novo Nordisk
Wednesday, 1 Mar 2017 05:30am EST 

Novo Nordisk A/S : Outgoing Novo Nordisk North America head Riis said he taking the role of Chief Executive of Danish emergency services group Falck .Riis says was disappointed to have missed out on CEO's job at Novo Nordisk last year.  Full Article

Novo Nordisk replaces head of North America operations
Wednesday, 1 Mar 2017 01:17am EST 

Novo Nordisk : Says Jakob Riis, executive vice president, head of North America operations and president of Novo Nordisk Inc. has resigned from company .Effective today, Doug Langa, senior vice president for market access, Novo Nordisk Inc., has been appointed senior vice president, head of North America operations.  Full Article

Novo Nordisk proposes Novo A/S CEO and former BG chief as board members
Friday, 24 Feb 2017 02:02am EST 

Novo Nordisk : Says the board of directors proposes election of Kasim Kutay and Helge Lund as new members of the board of directors at the annual general meeting . Kutay is CEO of Novo A/S, the holding company for the Novo group . "The Board of Directors recommends election of Mr Kutay primarily because of his extensive experience as financial advisor to the pharmaceutical, biotechnology and medical device industries" . Lund is former chief executive officer of BG and Statoil . "The Board of Directors recommends election of Mr Lund primarily because of his extensive executive and board experience in large multinational companies headquartered in Scandinavia within regulated markets and significant financial knowledge" .Proposes re-election of the following board members elected by the Annual General Meeting: Göran Ando (chairman), Jeppe Christiansen (vice chairman), Brian Daniels, Sylvie Grégoire, Liz Hewitt and Mary Szela.  Full Article

Evotec says will issue 13.1 million new shares to Novo A/S
Thursday, 9 Feb 2017 03:34pm EST 

Evotec Ag : Novo A/S becomes new long-term strategic shareholder in Evotec . It resolved on a capital increase from its authorised capital against cash . Evotec will issue 13.1 million new shares to Novo A/S .Novo A/S will invest eur 90.3 m to subscribe shares of evotec at a share price of eur 6.87 per share.  Full Article

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BRIEF-Xoma receieves notice to terminate license agreement from Novo Nordisk

* Xoma -on april 20, 2017 co received notice from Novo Nordisk a/s, relating to termination of exclusive license agreement with co due to strategic and business reasons