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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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Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.

Drug Review Approvals

CDER's Novel Approvals In 2018 Show Remarkable Review Consistency

Years of regulatory fine-tuning culminated in record low average time to approval of 9.9 months for novel agents at US FDA’s drug center.
Drug Review Drug Approval Standards

China In 2019: Coming Regulatory Changes To Keep On Your Radar

From heightened overseas manufacturing inspections to a new patent challenge mechanism, important regulatory changes are coming in China this year, and implementation could potentially derail your operations in this key market.

China Approvals

US Biosimilars: FDA Seeks To Build On Record Number Of Approvals, But Shutdown May Blunt Progress

Past year was the high-water mark for product approvals and launches, but complete response letters remain a frequent occurrence. FDA’s ability to deliver on its promise of further clarity on transition products, interchangeability and indication carve-outs/carve-ins may take a hit from the ongoing partial government shutdown. On the legal side, look for more patent settlements with staggered entry dates and new antitrust scrutiny.

Biosimilars Biologics

Oncology Dominates As China Approves Record 48 New Drugs In 2018

Despite multiple adverse factors including a leadership shakeup and the departure of its top regulator, the China FDA seemed determined to refresh itself after a name change and to speed up new drugs to market.

China Pink Sheet Perspectives

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

EU New Drug Approvals 2018: Anticancers, Orphans, The First CAR-Ts – And More

New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Approvals Europe

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
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