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FDA Needs More Aggressive Globalization Strategy – Sen. Brown

 
• By Derrick Gingery

The Ohio Democrat says FDA should be more creative in dealing with globalization problems than asking for funds to put more inspectors in China. Commissioner Hamburg says the agency is aggressive but lacks tools and resources to fully address globalization issues.

Commissioner Margaret Hamburg defended FDA’s globalization policies, particularly in dealing with inspections of manufacturing facilities in China, following a senator’s assertion that the agency could be more aggressive.

During an April 19 Senate Appropriations subcommittee hearing reviewing FDA’s fiscal 2013 budget request, Sen. Sherrod Brown asked how the...

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More from Europe

Not Over Yet: Eisai And Lilly To Appeal England’s ‘Flawed’ Refusal To Fund Leqembi And Kisunla

 
• By Neena Brizmohun

Eisai and Lilly explain why they disagree with today’s conclusion by the health technology assessment institute, NICE, that the benefits of their respective drugs for Alzheimer’s disease are too small to justify the additional cost to the National Health Service.

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

More from Geography

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.