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Key Developments: Novo Nordisk A/S (NVO)

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Latest Key Developments (Source: Significant Developments)

Novo Nordisk A/S announces positive results from semaglutide trial
Thursday, 28 Apr 2016 06:25am EDT 

Novo Nordisk A/S:Says semaglutide significantly reduces the risk of adverse cardiovascular events in Sustain 6 trial.Says trial achieved its primary endpoint of showing non-inferiority of cardiovascular events with semaglutide compared with placebo.Says trial showed a statistically significant reduction in cardiovascular risk.Says safety profile of semaglutide in Sustain 6 was as expected.Says expects to file semaglutide for regulatory review in the United States and the European Union in Q4 2016.  Full Article

Novo Nordisk to invest over EUR 100 mln in production plants in France
Wednesday, 20 Apr 2016 08:00pm EDT 

Novo Nordisk A/S:Plans to invest more than 100 million euros in production plants in Chartres, France.New facilities will be built on Novo Nordisk's existing 31,000 m2 site in Chartres.  Full Article

Novo Nordisk says Victoza reduces glycated haemoglobin more than sitagliptin
Monday, 4 Apr 2016 01:10am EDT 

Novo Nordisk A/S:Says Victoza provided superior HbA1c reductions in adults with type 2 diabetes compared to continued sitagliptin treatment.Says adverse events were more common in Victoza group versus sitagliptin group.There were no reports of severe hypoglycaemia and no reports of confirmed nocturnal hypoglycaemia.  Full Article

Novo Nordisk A/S says trial with Tresiba met primary end-point
Tuesday, 23 Feb 2016 05:01am EST 

Novo Nordisk A/S:Says Tresiba demonstrates significantly lower rate of hypoglycaemia than insulin glargine U100 in blinded phase 3b trial in people with type 1 diabetes.Says ‍trial met primary end-point by demonstrating non-inferiority in rate of severe or blood glucose confirmed symptomatic hypoglycemia of Tresiba compared to insulin glargine​.Says ‍expect to initiate filing of data from switch trials with regulatory authorities in Q3 2016 with aim of updating label for Tresiba.  Full Article

Novo Nordisk launches Tresiba in the United States
Tuesday, 26 Jan 2016 08:00am EST 

Novo Nordisk A/S:Novo Nordisk launches Tresiba in the United States.Long-acting Tresiba U-200 now available for adults living with diabetes.Tresiba (insulin degludec injection) is a once-daily, long-acting basal insulin.Tresiba was approved by the U.S. Food and Drug Administration (FDA) in September 2015.Novo Nordisk is working to secure coverage for Tresiba on U.S. health plans and has secured Lowest Brand Co-pay status on the national formulary for CVS Caremark.  Full Article

Novo Nordisk files for EU approval of haemophilia B treatment
Thursday, 7 Jan 2016 05:56am EST 

Novo Nordisk A/S:Says files for regulatory approval of long acting factor IX, nonacog beta pegol, in the EU for the treatment of haemophilia B.Say ‍expects to file biologics license application (BLA) for nonacog beta pegol to U.S. Food and Drug Administration (FDA) during first half of 2016.The filing of nonacog beta pegol is based on the results from the paradigm clinical trial programme, which involved 115 patients with severe or moderately severe haemophilia B.Nonacog beta pegol is an extended half-life factor IX molecule intended for replacement therapy in patients with haemophilia B.Glycopegylation, the prolongation technology used for the half-life extension, is a novel approach in haemophilia B, already proven safe and efficacious in haemophilia A and other therapeutic areas​.  Full Article

Novo Nordisk says ends 4th Phase 3a trial with semaglutide
Thursday, 17 Dec 2015 04:35am EST 

Novo Nordisk A/S:Successfully completes fourth phase 3a trial with semaglutide in people with type 2 diabetes.Expects to announce headline results of two remaining.Sustain trials in first half of 2016 Says ‍in trial, semaglutide appeared to have a safe and well-tolerated profile.Trial achieved its objective.Objective was to demonstrate that from mean baseline HbA1c of 8.1%, people treated with 0.5 mg or 1.0 mg semaglutide achieved statistically significant and superior improvement in HbA1c of 1.3% and 1.6% respectively, compared to improvement in HbA1c of 0.5% with 100 mg sitagliptin.The most common adverse event was nausea which diminished over time​.  Full Article

Novo Nordisk A/S files for EU approval of faster-acting diabetes drug
Friday, 4 Dec 2015 04:50am EST 

Novo Nordisk A/S:Filed for regulatory approval of faster-acting insulin drug aspart in the EU to the European authorities.  Full Article

XOMA announces license agreement with Novo Nordisk for XMEtA program in diabetes
Tuesday, 1 Dec 2015 08:30am EST 

XOMA Corp:Announces license agreement with Novo Nordisk for XMEtA program in diabetes.Says XOMA will receive $5.0 million in the form of an upfront payment.Says XOMA retains commercialization rights for rare disease indications.Agreement includes up to $290 million in potential development, regulatory and commercial milestones (excluding potential option payments).Says XOMA is entitled to tiered royalties.  Full Article

Ablynx announces nanobody drug discovery collaboration with Novo Nordisk
Wednesday, 25 Nov 2015 01:00am EST 

Ablynx NV:Announces nanobody drug discovery collaboration with Novo Nordisk A/S.Ablynx to receive a 5 million euro upfront payment, research funding, potential future milestones and royalties on net sale.If Novo Nordisk decides to exercise option to second programme, company will pay ablynx an exercise fee of 4 million euros.Collaboration and licensing agreement with Novo Nordisk to discover and develop novel multi-specific Nanobody drug candidates.In addition, Ablynx is eligible to receive potential development, regulatory and commercial milestone payments of up to 182 million euros per programme.Novo Nordisk will be responsible for the development, manufacturing and commercialisation of any products resulting from this agreement.  Full Article

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Diabetes drug test results boost Novo Nordisk

(This April 28 story corrects the fifth paragraph to say that two, not one, other diabetes drugs have positive cardiovascular side-effects)

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