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Product Reviews & Approvals

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Approvals

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Latest From Approvals

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

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

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

US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions

CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.

Drug Review Approvals

Not The End For Exondys In EU, Says Sarepta

Sarepta Therapeutics’ hopes of marketing its controversial Duchenne muscular dystrophy drug in the EU have again been dashed, but the company says it hopes to learn from EU regulators next year what it can do to get the drug to patients in Europe. Meanwhile, sales of the product are going well in the US.

Drug Review Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
European Performance Tracker Drug Review
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Drug Reviews

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Latest From Drug Review

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

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

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

US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions

CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.

Drug Review Approvals

Keeping Track: An Approval For Ajovy, A CRL For Ruconest, And Some Submissions from J&J

The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Performance Tracker Drug Review

Not The End For Exondys In EU, Says Sarepta

Sarepta Therapeutics’ hopes of marketing its controversial Duchenne muscular dystrophy drug in the EU have again been dashed, but the company says it hopes to learn from EU regulators next year what it can do to get the drug to patients in Europe. Meanwhile, sales of the product are going well in the US.

Drug Review Approvals
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