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Featured Stories



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 Regulation

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.

Advisory Committees Drug Review Review Pathway

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.

Generic Drugs Legal Issues 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 – July 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

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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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

US FDA September User Fee Calendar Slims Down, Still Boasts More Than Five Novel Agents

New therapies in the wings include two candidates for Niemman-Pick disease type C, a first-in-class antipsychotic, a targeted oncology therapy under Real-Time Oncology Review, and a new drug for gastroparesis.

US FDA Performance Tracker Drug Review
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

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

Advisory Committees Drug Review

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.

Rare Diseases Advisory Committees

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.

Europe Approvals

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.

Congo (Democratic Republic) Vaccines

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.

Europe EU

US Medicare To Offer Guidance On Real World Evidence To Support Coverage

The US Medicare agency is encouraging use of observational trials to fulfill Coverage With Evidence Development requirements, but details will await an upcoming guidance on “fit for purpose” studies.

Medicare Post Market Regulation & Studies

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

Flawed But Approvable? Crafting Indication Possible Focus Of Iterum’s Antibiotic AdComm

A second pivotal study may be enough to push Iterum’s antibiotic through its second FDA review, but data gaps raised concerns about inappropriate prescribing contributing to antimicrobial resistance and could limit marketing differentiation.

Advisory Committees Clinical Trials

Advanz Gains Temporary Block On Ocaliva’s Removal From EU Market

Despite its legal stay of execution, lack of confirmatory data means the European Commission’s decision for market removal is likely to stand.

Legal Issues Europe

English HTA Finally Greenlights Conditional Funding for MSD’s Welireg

MSD welcomes the decision but says the drug should have gone through NICE’s Highly Specialized Technologies route that allows more flexibility regarding uncertainty around rare disease drugs.

United Kingdom Health Technology Assessment

Cluster Wars: Korea’s Challenges In Shaping a Boston Style Biopharma Hub

South Korea has yet to come up with detailed plans for a major national biopharma cluster, but is considering a virtual approach to connect existing industry hubs nationwide. At a recent policy forum, experts discussed related issues including governance and insufficient investment, as well as the need to attract foreign firms and capital to compete with rival clusters in Asia.

South Korea Strategy

Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal

The going rate to buy a voucher for a faster US FDA application review is about $100m, but the France-headquartered firm received considerably more from an unnamed big pharma.

Rare Diseases Drug Review
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