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Aimmune’s Palforzia Gains US FDA Panel Nod But Faces REMS Restrictions

The agency’s plan to require a Risk Evaluation and Mitigation Strategy aimed at systemic allergic reactions with the peanut allergy immunotherapy did not go far enough, advisory committee members said, pushing for additional measures to be folded into the program.

Advisory Committees Drug Review Regulation

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 Regulation

FDA And EMA Evaluate Claims As Nitrosamine Worries Turn To Zantac

Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.

Manufacturing Quality Drug Safety
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Performance Trackers

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 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

Second Chance For Roche’s Polivy At CHMP

It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.

Europe BioPharmaceutical

Regulatory Digital Savvy: Taking China NMPA's New App For A Test Drive

At just the time when pretty much everything is going digital in China, the nation’s pharma regulatory agency has launched a new mobile application to put itself at your finger tips. And it’s time to give it a test drive.

China Regulation

US FDA Struggles To Meet Goals As Drug Sponsors' Meeting Requests Rise

The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.

Review Pathway FDA

Pharma Wary Of Over-Flexible EU Plan For Electronic Product Information

The pharmaceutical industry is concerned that too much flexibility may result in a “fragmented and cost intensive implementation” of the EU electronic product information framework.

Europe Regulation

EU Court Advances Understanding Of SPC Patent Puzzle

Pharmaceutical companies will have a better idea of the conditions under which a supplementary protection certificate can be granted after an advocate general of the European court explained how a new legal test established last year should be used. However, lawyers caution that the opinion still leaves some aspects to be clarified.

Europe Intellectual Property

Canada’s Drug Pricing Reform Faces Legal Challenge

Canada’s R&D drug industry says it approached the court as a “necessary step,” given the significant impact of the pricing reforms.

Canada Pricing Debate

Latest From Policy

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

Curative Gene Therapy Coverage May Need Government-Funded Risk Pools

Former US FDA commissioner Scott Gottlieb makes a case for regional or national risk pools to ensure pediatric patients get timely access to gene therapy like the upcoming treatments for sickle cell disease.

Pricing Debate 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

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

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy

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

Manufacturing Explore this Topic

Set Alert for Manufacturing

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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