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Tresiba Vs. Lantus: Novo Nordisk Scores A Win In Second Head-To-Head

 
• By Jessica Merrill

Novo revealed top-line results from SWITCH 1, showing Tresiba was superior to Lantus on a secondary endpoint of severe hypoglycemia in the maintenance period in type 1 diabetics, a positive after Tresiba failed to show superiority on the endpoint in another trial, SWITCH 2, in type 2 diabetes.

Novo Nordisk AS’ next-generation long-acting insulin Tresiba (insulin degludec) may get an edge competing against Sanofi’s venerable Lantus (insulin glargine) over Sanofi’s own next-generation basal insulin Toujeo (insulin glargine) after it showed superior hypoglycemia benefits versus Lantus in the second of two head-to-head trials.

Whether the incremental benefit seen with Tresiba or Toujeo will be enough to pit the newer insulins competitively against Lantus,...

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US FDA Plan To Limit Studies Eligible For Pediatric Exclusivity Criticized By Industry, NORD

 
• By Sue Sutter

The agency’s proposal to award six-month pediatric exclusivity only for studies beyond those required under the Pediatric Research Equity Act will weaken the incentive and result in less research for pediatric uses, stakeholders said.

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Germany: Newly Adopted Contractual Clauses To Reshape Clinical Trial Negotiations

 
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Newly enacted standard contractual clauses for negotiating clinical trial agreements in Germany appear positive for sponsors compared to the clauses that trial sites were typically requesting in the past, eg, those relating to compensation for the transfer of inventions, according to lawyers.

Better, Faster, Quicker: EUCOPE’s Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

 
• By Eliza Slawther

While the EU has many pieces of promising legislation in development, regulatory agencies should also prioritize making improvements within the existing framework rather than waiting for the new laws to take effect, EUCOPE secretary Alexander Natz says.

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OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
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