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Featured Stories



Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie

AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says. 

Advertising, Marketing & Sales Enforcement Regulation

Ocaliva Confirmatory Trial Failed To Verify Benefit In Primary Biliary Cholangitis, US FDA Says

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.

Advisory Committees Liver & Hepatic Regulation

EMA Targets New Opportunities For Bipolar Disorder With Update To Decades-Old Guide

The European Medicines Agency is planning to update its 23-year-old guideline on drugs for bipolar disorder to reflect changes in how mental disorders are classified. The update would open opportunities to develop medicines for patient groups that were not previously defined.

Europe Guidance Documents Regulation

Artificial Intelligence: How Regulators See It

Artificial Intelligence: CDER’s New Council Takes Charge Of Oversight, Coordination

The Artificial Intelligence Council takes over work that three different entities in the US FDA’s drugs center had been performing. The new, centralized entity will develop and promote consistency in AI-related activities and advance innovative uses.

Artificial Intelligence FDA

Read all of the Pink Sheet's artificial intelligence coverage...

Pink Sheet Podcast

Performance Trackers

US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

US FDA Performance Tracker Drug Review Drug Approval Standards

Global Pharma Guidance Tracker – August 2024

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


Multimedia

Clinical Trials In China: As US Lawmakers Consider Crackdown, Here Are The Implications

If the US Congress continues to target trials at Chinese military hospitals, the impact could be relatively small, while a broader focus could upend multinational development programs. 

Clinical Trials China

Obesity Drugs Will Get Broad Commercial Coverage In 2025 Despite Cost Concerns, Survey Says

The Business Group on Health survey also highlights employers’ complicated attitudes on prescription drug rebates in their health benefit programs.

Reimbursement Market Access

Diversity Action Plans: What To Submit And When

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.

Clinical Trials Diversity & Inclusion

US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization

Under current law, drugs or biologics must receive rare pediatric disease designation before 1 October to be eligible for a priority review voucher. The sunset provisions caused a spike in designation requests and a push by pediatric and rare disease advocates for an extension.

Rare Diseases Legislation
Regional Comparisons

EU Revokes Intercept/Advanz’s Ocaliva Approval As Moment Of Reckoning Nears in US

The EU marketing authorization for the primary biliary cholangitis treatment has now been revoked. Meanwhile the drug's approval is in jeopardy in the US, where an advisory committee will opine on whether the accelerated approval drug has confirmed clinical benefit.

Regional Comparisons Post Market Regulation & Studies

England Lags Behind Eight European Countries On Innovative Drug Availability

In this third article of a series on new drug reimbursement recommendations by the HTA body NICE, the Pink Sheet finds that fewer innovative medicines are reimbursed in England than in eight other European nations.

BioPharmaceutical Europe

Decoding Regulatory Agency Decisions: The Case of Amylyx’s Relyvrio/Albrioza In The US And EU

Relyvrio/Albrioza, Amylyx’s ill-fated treatment for amyotrophic lateral sclerosis, was approved for marketing by the US Food and Drug Administration but rejected by the European Medicines Agency. The Pink Sheet explores how the two agencies applied the available regulatory flexibilities and the impact of other factors, such as regulatory precedence and patient influence, on decision-making.

Europe United States

Pink Sheet Podcast Special: Why The US Approves Most New Drugs Before The EU

Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments.

Regional Comparisons Approvals
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Recent Stories

Korea Revamps Drug Review Processes, Cuts Approval Timelines

Under the new drug approval innovation measures, Korea will cut the review and approval period of new drugs to 295 days from 420 days and increase the number of expert reviewers to enhance review capabilities.

South Korea Drug Review

New EU Filings

Pridopidine, Prilenia Therapeutics’ investigational treatment for Huntington’s disease, is among the latest products that the European Medicines Agency has started reviewing for potential pan-EU marketing authorization.

Drug Review Europe

Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges

Disputes over orphan and new clinical investigation exclusivity are among the early drug and biologic cases where legal filings cite the Loper Bright decision, which overturned the Chevron doctrine of deference to agency actions.

Legal Issues Drug Approval Standards

Would National US HTA/Price Negotiation Process Slow Drug Access? Maybe Not

Research published in the Annals of Internal Medicine finds the US time from a drug’s approval to reimbursement is not the swiftest, compared to countries in Europe.

Reimbursement Health Technology Assessment

Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn

Determining what falls within the statutory definition of ‘biological product’ is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court’s June decision in Loper Bright.

Legal Issues Biologics

Spain Consults On Plans To Regulate HTAs

New rules on health technology assessments in Spain make room for real-world evidence and early dialogue.

Europe Spain

New EU Filings Include A Range Of First-Of-Their-Kind Therapies

Pridopidine, sebetralstat and mirdametinib, which are novel treatments that are yet to approved anywhere in the world, are among the latest products for which marketing applications are now under review by the European Medicines Agency.

Europe Drug Review

Lilly And EVA Pharma Sign Voluntary License Deal For Baricitinib In Africa

Eli Lilly will provide a know-how manufacturing guide to EVA Pharma, as it prepares to manufacture and sell baricitinib by 2026.

Deals Intellectual Property

US FDA Advisors Want Iterum’s Antibiotic Indication Narrowed

The agency’s Antimicrobial Drugs Advisory Committee suggested a more limited indication for Interum’s antibiotic for uncomplicated urinary tract infections than the sponsor proposed, though it wasn’t necessarily clear committee members favored approval.

Advisory Committees Women's Health

Generic Drug Sponsors May Discuss Alternative BE Approaches During Pre-ANDA Meetings

Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”

Generic Drugs Guidance Documents

US FDA’s Marks Issues ‘Provocative’ Call For Target Gene Therapy Profile That Includes Costs

CBER Director Peter Marks said recent leaps in gene therapy science have not been matched by more affordable manufacturing technology and that the field needs to set a cost-effectiveness target. 

Gene Therapy Cost Effectiveness

EMA Probe Prompts New Safety Measures For Decades-Old Drug Metamizole

The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.

Europe Drug Safety
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