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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.
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.
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.
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.
Read all of the Pink Sheet's artificial intelligence coverage...
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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.
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.
US FDA Performance Tracker
European Performance Tracker
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Spain Consults On Plans To Regulate HTAs
New rules on health technology assessments in Spain make room for real-world evidence and early dialogue.
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.
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.
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.
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.”
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.
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.
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