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Latest From Research & Development

Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

Policy Research & Development

Pivotal Trials Are Cheaper For Unmet Needs And Orphan Drugs, JAMA Study Finds

Analysis of clinical trial costs for CDER’s 2015-2016 novel therapeutic approvals finds pivotal studies are most expensive when a new agent has a similar benefit to already marketed products with well-established clinical profiles. 
Clinical Trials Research and Development Strategies

Repeated Questions Prompt EMA To Reconsider Guidance On Neonates

The European Medicines Agency wants to update its guidance on the investigation of drugs in term and preterm neonates to reflect the “considerable experience” it has gained in assessing pediatric investigation plans.
Clinical Trials Research & Development

Making Real World Evidence Less 'Messy' To Help With Drug Pricing

The Medicines Company's inclisirin CV trial is 100-fold cheaper with digitized records, while Lilly is still hunting for a good HBA1C dataset, and Merck worries about "idiosyncratic" data.

Pricing Strategies Research & Development

Biosimilars: Is Small Dip In Development Indicative Of Sustained Downward Trend?

As US FDA sees dip in application development, experts offer contrasting assessments about future of biosimilars at AAM's GRx Biosims conference. 
Biosimilars Research & Development

EMA Clarifies Role Of And Need For Data Monitoring Committees

The European Medicines Agency is seeking feedback on a new Q&A it has prepared on the use of data monitoring committees by sponsors.

Clinical Trials Research & Development
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