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Novartis Revises U.S. Regulatory Strategy For Key Respiratory Drug

 
• By Jessica Merrill

The Swiss drug maker says it has agreed with FDA on a Phase III trial design for the combination respiratory drug QVA149 and expects to file in late 2014; plan now calls for testing a twice-daily dose in addition to once-daily.

An important drug in Novartis AG’s respiratory pipeline has been sidelined in the U.S. by FDA’s crackdown on the safety of long-acting beta2-adrenergic agonists, but during an April 24 quarterly earnings call, management said it has made progress on the regulatory strategy for QVA149.

The drug is a combination product containing Novartis’ marketed LABA indacaterol and investigational long-acting muscarinic antagonist (LAMA) NVA237 (glycopyrronium bromide)....

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More from Clinical Trials

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.

US Policy Shift Sparks German Contingency Plans For Accessing ClinicalTrials.gov, PubMed

 
• By Francesca Bruce

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

More from R&D

Results Reporting: UK Registry To Offer More Flexibility Than US-Based ClinicalTrials.gov

 
• By Vibha Sharma

ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.

UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments

 
• By Vibha Sharma

Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.