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A Cold Shower For Viagra: How Congress Can Chill A Market

 
• By Michael McCaughan

Pfizer, Lilly and the other marketers of drugs for erectile dysfunction are kicked out of Medicare and Medicaid. Viagra and the other brands may be the first victims of the backlash against DTC advertising. They are also a case study in how Congress can--and well--make mischief under the Medicare program.

By Michael McCaughan

Where is Bob Dole when you need him? Congress has cut off federal spending on drugs to treat erectile dysfunction, claiming the Treasury will save $690 million over the next...

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More from Platform Technologies

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

UK MHRA Consults On The Way For Personalized mRNA Cancer Therapies

 
• By Eliza Slawther

The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.

‘Ambitious Platform’ Among EU Proposals For Increasing mHealth Data Use In Regulatory Decision-Making

 
• By Neena Brizmohun

mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.

US FDA Not Ready For Sponsors Citing Others’ Platforms Yet, Marks Says

 
• By Derrick Gingery

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

More from Advanced Technologies

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.