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.
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.
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.
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 – 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.
US FDA Performance Tracker
European Performance Tracker
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.
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
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.
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
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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.
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.
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.
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.
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.
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.
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.
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.
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