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Latest News & Analysis

Warnings Up As US FDA Trims List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign firms making OTC drugs marketed in US had not been inspected for GMPs compliance before FDA Safety and Innovation Act pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and Jan. 9, 2018, 25% received "official action indicated" inspection results, driving warning letters and import alerts.

Consumer Enforcement

EU Drug Filings To Fall Slightly In 2019, But Scientific Advice On The Up

The EMA expects initial applications for drug approvals to decline slightly next year, with the budget also down a little because of Brexit uncertainty. The agency's management board reported on its visit to the agency’s future home in Amsterdam. 
Drug Review Regulation

Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations

Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP.  Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn its application for another.

Europe Regulation

New Russian Quality Assurance Rules Could Push Up Costs & Delay Product Launches

New rules aimed at tightening quality control on medicines that are to be introduced in Russia next year are expected to help prevent low-quality drugs getting to the market. However, they will bring some additional costs for pharmaceutical companies. It is also being suggested they could lead to delays in product launches.

Regulation Russian Federation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Has R&D Productivity Rebounded? US FDA Officials Think So

Record-setting pace of NME approvals is a cause for celebration. But is it a sign that drug industry R&D productivity has actually improved? The US FDA’s top drug review official thinks so – but the data aren’t yet clear.
Drug Review FDA

US FDA May Ask Congress For More Resources After Withdrawing Generic Label Reg

Label updates for older generics are still planned, Commissioner Gottlieb says, but will depend more on sponsor collaboration as well as additional resources and authorities from Congress.
Generic Drugs FDA

Cost Concerns May Hinder Naloxone Co-Prescribing Ideas

US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.
Neurology Pricing Debate

US FDA Warning Letter Hits Huahai For Failure To Prevent Valsartan Contamination

Zhejiang Huahai should have realized its valsartan API was tainted by the probable carcinogen NDMA, FDA says in warning letter, despite earlier statement from agency leadership to the contrary.

Enforcement Manufacturing

Mylan Scores IPR Victory, Paving The Way For Follow-On Lantus

US Patent and Trademark Office invalidated two patents covering Sanofi's Lantus vial, clearing the way for Mylan to launch a follow-on product after FDA approval.

Biosimilars Metabolic Disorders

EMA Clarifies Sponsor Role In Contracting For Investigator Sites

The European Medicines Agency has made it clear that all clinical trial-related medical activities are the responsibility of the investigator and that a sponsor cannot contract these to a third party. Also, the EMA discourages performing trial procedures at a patient's house, unless duly justified.
Europe Clinical Trials

UK Inquiry Into ‘Unfair’ Orkambi Pricing Risks Pricing Confidentiality

The UK government has criticized Vertex for the company’s approach to pricing its cystic fibrosis drug Orkambi. In the meantime, a parliamentary inquiry that could expose sensitive pricing details moves forward.

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