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Featured Stories


Firms Still In Dark Over No-Deal Brexit Supply Routes

Life science companies need more information on plans for alternative medicine supply routes if the UK leaves the EU without a deal, according to the BioIndustry Association, which says the release of the Operation Yellowhammer document shows the “significant impact” such an outcome would have on the sector.

Brexit United Kingdom Trade

RWD Key To Scottish Orkambi Deal

Vertex has managed to secure a deal to provide Scottish cystic fibrosis patients with access to Orkambi and Symkevi. The promise of real world data and a price discount has convinced the Scottish government to say yes to the treatments, which had earlier been rejected by the Scottish Medicines Consortium.

Europe United Kingdom Health Technology Assessment

Everything's Special At US FDA: Priority NDA/BLA Filings Surge

The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.

Drug Review Regulation Review Pathway
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Performance Trackers

Keeping Track: Ofev Snags SSc-ILD Indication, Accelerated Approval Reviews For Veverimer And Voxelotor, J&J Gets Its First Vaccine BTD

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

US FDA Performance Tracker Approvals Drug Review

Global Pharma Guidance Tracker – August 2019

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents International Australia

Policy & Regulation Explore this Topic

Set Alert for Policy & Regulation

Latest From Regulation

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

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

Pink Sheet Podcast: Upcoming Opioids Policy Meeting, Improving US FDA's Rare Disease Legalese

Pink Sheet reporters discuss the proposed opioid lawsuit settlement, Public Citizen's opioid citizen petition denial, and the upcoming FDA public meeting on opioid standards, as well as a proposal to better outline agency flexibility with rare disease drugs.

Drug Approval Standards Neurology

New European Pharmacopoeia Reflects Regulatory And Scientific Progress

The European Pharmacopoeia, which has been updated to reflect regulatory and scientific advances, contains 114 new monographs including substances of “high therapeutic interest.” Holders of CEPs have been advised to update their certificates in line with the new monographs.

Europe Quality

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

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Europe Drug Review

Public Citizen Strikes Out In Call For Opioid Approval Moratorium After Recent Win

Petition was consumer advocacy group's first request for halt to approval of an entire drug class; Public Citizen has gotten full and partial approval of other recent petitions.

Drug Approval Standards FDA

Latest From Policy

The New Payer Dogma: US FDA Approved Drugs Have 'Less Evidence'

It is now a common assertion among insurers that one of the many challenges they face in covering high-priced specialty therapies is that drugs are approved with “less evidence” than used to be the case. That is more myth than reality – but a very dangerous myth if it isn’t corrected by the US FDA and the drug industry.

Drug Approval Standards Pricing Debate

Brineura Cleared By England's NICE For Ultra-Rare Batten Disease

NICE has recommended BioMarin’s Brineura for use in the National Health Service in England after a managed access deal and product pricing were agreed between BioMarin and NHS England. Final details of the deal are expected next month.

 

 

Health Technology Assessment Neurology

House Democrats And Price Negotiation: Slogan Is Unifying, But Policy Is Tougher

The most important thing to know about a draft version of the House Democratic leadership’s proposed drug price negotiation plan is that it is still just a draft – not the draft – much less a bill that could pass the Democratic controlled House, to say nothing of the GOP controlled Senate.

Pricing Debate Legislation

Clinical / R&D Explore this Topic

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Latest From Research & Development

Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients

US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.

Drug Approval Standards Cardiovascular

Cures 2.0: Can Congress Recapture The Legislative Magic?

Primary sponsors of the 21st Century Cures Act are trying to get the band back together. Is there hope to recapture a bipartisan, pro-innovation spirit in the current US Congress?

Legislation Review Pathway

NHS England Tackles Barriers To Use Of Cannabis-Based Medicines

A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns. 

United Kingdom Neurology

Commercial Explore this Topic

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Latest From Commercial

Purdue Nears Settlement Of Opioid Multidistrict Litigation, But State AGs Vow To Press On

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Legal Issues Policy

Novartis’ “Living Drugs”: Kymriah, Zolgensma – And Diovan?

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

Commercial Manufacturing

Sunset Begins For Roche's Herceptin As Amgen/Allergan Biosimilar Launches

Amgen and Allergan launched the first US biosimilar for Roche's Herceptinand the Swiss pharma's Avastin – at a 15% discount to the brand-name products' list prices. Infographic reviews Herceptin's past and its future competitors.

Biosimilars Launches

Manufacturing Explore this Topic

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Latest From Manufacturing

The US FDA Acts To Bolster Adverse Event Reporting For Compounded Drugs

After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.

Manufacturing Quality

GS1 Standard Would Speed The Sale Of Returned Drugs After November Deadline

New messaging standard from GS1 would enable industry to sell most returned drugs after November DSCSA deadline without running afoul of the FDA.

Distribution Manufacturing

The FDA Proposes Adding Five Of 31 Drug Substances To 503A Bulks List

FDA proposal would allow traditional compounding from five drug substances based on medical need, but not from another 26.

 

Manufacturing Quality
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