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Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate Regulation

European Commission Dangles Conditional Approval Reprieve For PTC Therapeutics’ Translarna

Scientific questions from member state experts and a recent court ruling on impartiality in the drug approval process prompted the European Commission to query the EMA’s negative opinion on PTC’s Translarna.

Europe Drug Review Market Access

The Looming US Election Weighs On The Minds Of Pharma

The November US presidential election could mean IRA expansion if President Biden wins, but a Trump victory brings uncertainty.

Politics Pricing Debate Policy

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Performance Trackers

PTC’s Upstaza Takes Gene Therapy Straight To Brain (And US FDA); Translarna To Return Mid-Year

In a year full of regulatory milestones for the firm, PTC Therapeutics hopes to set some approval precedents – and basically hopes its candidates have an easier time of it than they have had before.

US FDA Performance Tracker Gene Therapy Drug Approval Standards

Global Pharma Guidance Tracker – April 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


As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs

Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.

Legislation Manufacturing

US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall

After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

Generic Drugs Guidance Documents

Medicare Negotiation Timeline For Prices To Be Implemented In 2027

The schedule for the second round of negotiations is different from the first cycle, in part because the Inflation Reduction Act allowed for extra time initially as the program launched. The first- and second-year timelines also overlap: The second negotiation cycle will begin before the first cycle prices are implemented. 

Medicare Pricing Debate

ICER Debuts Clinical Trial Diversity Assessment Framework

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

Diversity & Inclusion Clinical Trials
Regional Comparisons

Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Generic Drugs Regional Comparisons

For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

Generic Drugs Regional Comparisons

How The EU & UK’s Contrasting Approaches To AI Regulation Could Impact Pharma

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

Artificial Intelligence Digital Health

For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

Drug Approval Standards Guidance Documents
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Recent Stories

Former Sandoz Exec Kellum Avoids Jail Time Over US Price Fixing

Four years after pleading guilty plea generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside a jail cell and pay a fine.

Legal Issues Generic Drugs

European Pharmacopoeia Gets To Grips With Quality Standards for mRNA Vaccines

Stakeholders have until 30 June to comment on a set of common quality standards for mRNA vaccines that are said to be needed in light of rapid developments in this field and the emergence of novel vaccines coding for a range of specific antigens.

Vaccines Quality

France Reveals The Drugs That Are Most Likely To Require Post-Market RWE Studies

A study from the health technology assessment department of France’s national health agency, HAS, has identified which pharmaceutical products are most likely to receive a request for post-market studies. The agency hopes this information will aid in companies’ forward planning.

BioPharmaceutical Health Technology Assessment

More Pediatric Cancer Trials Conducted Due To RACE Act

Initial data looks promising as the FDA’s pediatric oncology subcommittee is set to discuss how recent legislative changes have impacted pediatric cancer drug development. 

Advisory Committees Pediatrics

US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution’ In Research

The Center for Drug Evaluation and Research’s new Center for Clinical Trial Innovation (C3TI) may lead a “targeted” effort to update the FDA’s regulatory framework given advances in trial design and execution, CDER Director Patrizia Cavazzoni said. Industry already has asks.

Clinical Trials Research & Development

‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

Clinical Trials Diversity & Inclusion

EU To Suspend 17-OHPC Preterm Birth Drugs A Year After US Pulled Makena

17-OHPC medicines are to be pulled from the market in Europe due to a potential link with cancer and the lack of efficacy data. The move comes around a year after the US regulator withdrew its approval of a similar drug from Covis.

Post Market Regulation & Studies Europe

End In Sight For Onerous EU Signal Detection Pilot

A keenly-awaited legislative amendment that is expected to be adopted by the end of this year would introduce more proportionate requirements for drug sponsors to monitor the EudraVigilance database.

Europe Drug Safety

EMA Updates Trials Portal With New Fields On Sharing Participant Data

Sponsors can now disclose their intention of sharing deidentified individual participant data when they register a study in the EU Clinical Trials Information System. The changes are part of ongoing efforts to establish CTIS as a World Health Organization primary registry.

Europe Clinical Trials

Brand Drug Shortages Complicate US FDA Messaging To Congress

The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different. 

Generic Drugs Manufacturing

Relyvrio’s Failure Sparks NeuroSense ALS Development Changes

NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.

Neurology Clinical Trials

Pink Sheet Podcast: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.

Legislation Clinical Trials