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Regulatory Flexibility: US FDA Approves Amylyx’s Relyvrio For ALS Despite ‘Degree Of Residual Uncertainty’

The single positive Phase II CENTAUR study, along with confirmatory evidence of benefit on long-term survival in the open-label extension, demonstrate substantial evidence of effectiveness, the agency says, acknowledging a level of uncertainty that is acceptable in the disease context.

Approvals Drug Review Rare Diseases

EU To Kick Off ‘Joint Action’ On Tackling Drug Shortages

The joint action on ensuring security of medicines supply will be supported by the EU regulators’ shortages task force, which is to track efforts to coordinate member state activities on the supply and availability of medicines.

Europe Regulation Supply Chain

OIG Accelerated Approval Report Spotlights Financial Costs Ahead Of Congressional Debate

First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.

FDA Clinical Trials Government Payers

Drug Pricing Reform In The US

US Price Negotiation Process: Is Case-By-Case Politically Sustainable?

Republican Congressional letter asking HHS nuts-and-bolts questions about the newly enacted drug price ‘negotiation’ law points to a much more fundamental issue: can a bureaucratic agency make the program work in a manner that appears credible and free of undue political interference?

Pricing Debate Medicare

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Performance Trackers

Keeping Track: After COVID Delays, US FDA Approvals At Last For Daxxify, Rolvedon (But A CRL For Alvotech)

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.



Global Pharma Guidance Tracker – August 2022

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 Regulation International

Policy & Regulation Explore this Topic

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Latest From Regulation

Novel Brain Penetrant For Treating X-ALD Among Raft Of New EU Filings

Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.

Europe Approvals

AB Science & Daiichi Try Their Luck Again With EU Filings

The sponsors of Alsitek and quizartinib are hoping that new data generated for the drugs will resolve the concerns raised by the European Medicines Agency when it previously rejected the products for marketing in the EU.

Drug Review Europe

Evusheld: UK Urged To Use RWD To Give Clinically Vulnerable Early Access To COVID-19 Treatment

A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection. 

United Kingdom Coronavirus COVID-19

Amylyx's Relyvrio: The Road To Regulatory Flexibility And US FDA Approval

A Pink Sheet timeline shows the regulatory highs and lows of AMX0035's path to US approval for treatment of amyotrophic lateral sclerosis.

Approvals Drug Review

How Will Approval Of Amylyx’s Relyvrio Impact The Ongoing PHOENIX Trial?

Launched in part to help resurrect AMX0035’s regulatory prospects, the multiregional PHOENIX study is winding down in the US. There still may be some risk of potential dropouts, however.

Approvals Clinical Trials

Pandemic Treaty: WHO To Broadcast Videos Of Stakeholders ‘Wishlists’

Hundreds of videos have been sent in by people interested in contributing to the future pandemic treaty proposed by the World Health Organization.

Coronavirus COVID-19 Regulation

Latest From Policy

Medicare Part B Premium Reduction In 2023 Has Reserves Built In If Lecanemab Launches

But premiums in future years made need to keep pace with accelerating Medicare spending on Alzheimer’s drugs.

Reimbursement Medicare

Brazilian HTA To Adopt Cost-Effectiveness Thresholds

Brazil’s health technology assessment institute is to incorporate cost-effectiveness thresholds into its decision making.

South America Brazil

Lecanemab And Medicare: Could Better FDA/CMS Communication Improve Coverage Chances?

Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.

Reimbursement Medicare

Clinical / R&D Explore this Topic

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Latest From Research & Development

Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues

Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.

User Fees Coronavirus COVID-19

Gene Therapy For Lethal Glycogen Storage Disease Wins EMA PRIME Designation

Investigational products from Ultragenyx and MinervaX secured a place on the European Medicines Agency’s priority medicines scheme this month.

Research & Development Review Pathway

GDUFA Research Impacting Generic Development, ANDA Approvals

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

Generic Drugs Research & Development

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Japan’s Biopharma Excellence Celebrated At Pharma Intelligence Awards

Excellence, innovation, deal-making and individual achievement across the Japanese biopharma sector were celebrated at the inaugural Pharma Intelligence Japan Awards 2022 in Tokyo on 1 September.

Japan Commercial

Moderna’s Suit Against Pfizer Could Result In ‘Modest Royalties’ Paid By Both Rivals

Moderna seeks damages for sales of Comirnaty in US and other wealthy countries from 8 March onward, a timeframe driven by Moderna's accessibility pledge. Suit claims Pfizer and BioNTech copied two key features of its mRNA technology for their rival COVID vaccine.

Coronavirus COVID-19 Vaccines

Amgen Aims To Stay Regeneron Antitrust Suit Based On Possible Supreme Court Action

Amgen says contracts it submitted to district court show Otezla rebates were not conditioned on customers covering its cholesterol-lowering drug Repatha instead of Regeneron’s Praluent. It requests stay of the litigation until Supreme Court acts on Amgen’s cert petition on the patent case between the two competitors.

Legal Issues Intellectual Property

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Latest From Manufacturing

Pre-work Rigour, 'Clean' Documentation Key As FDA Unlocks Remote Inspection Tools

A senior Parexel executive and ex-FDA pharmaceutical quality assessor emphasizes at a conclave why “first impressions matter now more than ever” as the agency  deploys complex alternate inspections tools which the pandemic provided, and that companies need to ensure that they get things right the first time.

Manufacturing Compliance

Eager But Wary: Industry Seeks More Useful, More Detailed Remote Regulatory Assessment Processes

Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.

Manufacturing Quality

FDA Allowed Release Of Moderna COVID Booster While Still Mulling Plant Inspection Findings

Memo outlines how US agency ensured sufficient delivery of updated COVID-19 vaccine doses even as it navigated unresolved inspection findings of the Catalent plant where the additional doses had been manufactured.

Coronavirus COVID-19 Vaccines
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