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One Lesson Of The OND Reorg: It Is Hard To Classify Diseases

 
• By Michael McCaughan

One goal of proposed overhaul of US FDA’s Office of New Drugs is creating more logical alignment of related diseases within divisions and offices. That is easier said than done.

two hands trying to connect couple puzzle piece with sunset background. Jigsaw alone wooden puzzle against sun rays. one part of whole. symbol of association and connection. business strategy.

The US FDA’s first public unveiling of the planned overhaul of the Office of New Drugs is filling in some of the details on a critical structural change for biopharma companies.

One thing has been clear for several weeks: the new OND will have more drug review divisions and offices. (Also see "US Office Of New Drugs Revamp Taking Shape:...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

New EU Approvals

 
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

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US ‘Most Favored Nations’ Drug Pricing Policy Will Jeopardize Innovation In Europe

 
• By Francesca Bruce

The US MFN executive order is the latest in a series of concerning US developments that are contributing to uncertainty for the European pharmaceutical industry, according to France Biotech’s vice president, Alexandre Regniault.

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
• By Eliza Slawther

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

China NMPA Lays Out Regulatory Priorities At DIA

 
• By Xu Hu

At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.