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Pink Sheet Perspectives

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Opioid Sponsors Enter 2019 At A Crossroads

Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the analgesics to market. 
Research & Development Neurology Advisory Committees

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US FDA Advertising Citations Remain Rare In 2018

With only seven letters last year, Office of Prescription Drug Promotion appears to be continuing its enforcement retrenchment as agency reconsiders its approach to Rx communications.

Advertising, Marketing & Sales Enforcement

2018 Complete Response Letters: Efficacy Issues Drove Most Product Rejections

US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.

Complete Response Letters Drug Review

US FDA's Brexit: One Staffer Moving, But Impact Still May Loom Large

Uncertainty about Brexit's impact on the FDA-EMA mutual recognition agreement are among issues worrying regulators as countdown continues to the UK's departure from the EU.
Brexit FDA

US FDA’s Record Year For Drug Approvals? Wall Street Is Unimpressed

Pace of new US drug approvals is unprecedented, but investors continue to shun biopharma industry. Uncertainty about pricing environment is clearly outweighing the favorable regulatory climate. Stocks in the sector closed the year down more than 15% are still trading well below 2015 levels. 
Pricing Debate Approvals

US FDA’s Record Tally Of NMEs Outpaces Ability To Issue Press Releases

US FDA may have set record for new drug approvals during 2018, but agency actually issued press releases highlighting approvals less often than it has in the past.
Approvals FDA

Orphan Drugs Compose Majority Of Novel US Approvals For First Time Ever In 2018

Orphan drugs and priority reviews achieved historic highs in CDER's 2018 novel approval class, but share of products with breakthrough therapies took a slide. 
Approvals Drug Review

US FDA’s Best Year Ever For New Drugs: CDER Novel Approvals Hit 59

FDA’s drug center smashes its past records for new molecular entities and therapeutic biologic approvals; with five novel biologics approved by FDA’s biologics center, the agency’s novel approvals reach a stunning total of 64. 
Approvals Drug Review

Eight For 8: Things You Need To Know About China Biopharma Regulation In 2018

The Pink Sheet's pick of eight major events that captured major regulatory developments in China’s dynamic, highly fluid biopharma scene in 2018.

China Drug Approval Standards
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