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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.
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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
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.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
Glenmark Shells Out Another $25m To Resolve Civil Price-Fixing Charges
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
They’re Back! US FDA Panels Return To Normal And The Schedule Fills Up Fast
The US FDA is returning to the pre-COVID in-person advisory committee format and the agency suddenly has a flood of meetings lined up for the fall.
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.
Pink Sheet Podcast: Rare Pediatric Disease PRV Deadline, Potential Makena Compounding Ban
Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset, as well as an upcoming agency advisory committee meeting on potentially banning compounding of the active ingredient in the now-withdrawn pre-term birth prevention drug Makena.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add seven new products, including Winrevair, MSD's treatment for pulmonary arterial hypertension.
DRC Gets First Mpox Vaccine Shipment & Issues EUA Ahead Of WHO Listing
The Democratic Republic of Congo, the country worst hit by the mpox crisis, has now received the first batch of vaccines for the disease. Meanwhile, the World Health Organization is expected to complete its review for emergency use listing of mpox vaccines soon.
EU Regulators Should Use AI Only When ‘Safe And Responsible,’ Says EMA
Medicines regulators in the EU have “much to gain” from using AI models in their processes, but this technology must be used in a “safe and responsible” way, says the European Medicines Agency.
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