Signifor Approval Highlights Success Of Novartis’ Parallel Development Strategy

Following its approval in Europe earlier in 2012, the FDA approval of Signifor for Cushing’s disease is just the latest piece of a strategy to bring the injectable to market in multiple indications, including acromegaly.

With its FDA approval for Cushing’s disease, Novartis AG’s Signifor (pasireotide) is now cleared in both the U.S. and Europe as the first drug for the orphan condition. But Cushing’s is just part of the pharma’s strategy for pasireotide – it also plans to file for approval in acromegaly in 2013 and later for carcinoid neuroendocrine tumors.

The approach being used with pasireotide is a parallel development strategy that CEO Joe Jimenez has credited with helping Novartis to reduce drug-development timelines. During Novartis’ Nov. 8 R&D day, Jimenez noted that back in 2007 when the company was in dire straits due to the patent expiration of Diovan (valsartan), it was moving forward with a new R&D strategy within its Novartis Institute for Biomedical Research

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By 

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By 

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

More from R&D

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By 

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.