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Latest News & Analysis

Cleveland Clinic “Outsourcing”? 503B Status Would Be Milestone For US FDA’s Compounding Model

Chronic problem with drug shortages is driving the Cleveland Clinic to consider registering as a 503B “outsourcing” facility. That could be a milestone in FDA’s efforts to encourage the model for high volume compounders.

To Lower Drug Prices, Look At Generic Industry Health Rather Than FDA, Woodcock Says

US FDA can encourage and increase competition, but cannot force generic companies to enter markets deemed unprofitable, CDER director says.
Pricing Debate Generic Drugs

Opioids Could Become Bioterror Weapons, US Fears; BARDA Funds Countermeasures

Opiant could get $4.6m to accelerate development of nasal nalmefene for treatment of opioid overdose.

Policy Research & Development

Pivotal Trials Are Cheaper For Unmet Needs And Orphan Drugs, JAMA Study Finds

Analysis of clinical trial costs for CDER’s 2015-2016 novel therapeutic approvals finds pivotal studies are most expensive when a new agent has a similar benefit to already marketed products with well-established clinical profiles. 
Clinical Trials Research and Development Strategies

The Quality Lowdown: The More Things Change …

US FDA inspection offers hints that Zhejiang Huahai’s genotoxic valsartan impurity could have been caught earlier, while EMA expands its quality review to other sartans that contain the same trouble-prone tetrazole ring. A micro lab will have to jettison its microbrewery, and compounding supplier Fagron must ID its API sources.

Manufacturing Quality

Brexit: Number Of Drugs At Risk Of Shortage Cut From 108 to 39

The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.

Brexit Regulation

Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

EMA Targets Sponsors That Post Trial Results Too Late

Too many clinical trial sponsors are late in to reporting their study results on the publicly available EU Clinical Trials Register, and the European Medicines Agency is planning to chase up the laggards.

Clinical Trials Compliance

EU Approval Set For Three New Orphans And Lilly’s Emgality; Exondys Appeal Fails

The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.

Europe Drug Review

English Court Queries EMA Primacy & Says Avastin Can Be Used In AMD

The English High Court has rejected attempts by Novartis and Roche to stop clinical commissioning groups from offering Avastin to wet AMD patients in a cost-containment move. In a development that has alarmed pharma firms, the court also questioned the exclusive role of the European Medicines Agency in marketing authorizations, saying that CCGs as well as the health technology assessment body, NICE, have competences in that area, and called on the UK regulator to review its guidance on off-label and unlicensed use.

Reimbursement Regulation

Advertising Enforcement: US FDA Content To Let Competitors 'Duke It Out,' Woodcock Says

Office of Prescription Drug Promotion is focused on most egregious issues where human safety is at stake; CDER's Woodcock also says that First Amendment issues are affecting enforcement.
Advertising, Marketing & Sales FDA

Biosimilar Action Packages Low On US FDA Priority List For Redaction And Posting

Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.


Biosimilars Drug Review
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