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Featured Stories



Japan Reimburses Zolbetuximab, To Cut Price Of Imfinzi, Others

The first-in-class anti-CLDN 18.2 antibody zolbetuximab will face cost-effectiveness assessment in Japan in the near future, as the country applies stricter reimbursement pricing policies to gain transparency in expenditure through its healthcare reimbursement structure.

Japan Pricing Strategies Reimbursement

NGGT Progresses First US Gene Therapy Trials For Rare Conditions

Next Generation Gene Therapeutics is fast-tracking clinical trials in the US for its gene therapy candidates for Bietti's crystalline dystrophy and classic phenylketonuria, supported by China data, the Chinese venture's CEO says in an interview.

China Clinical Trials Rare Diseases

'We Are Not Waiting To Be Replaced': Medical Affairs Pros Take On GPT-4o

Faster, more powerful and able to handle voices and visual images, newly released AI platform GPT-4o could potentially accelerate many tasks currently handled by pharma firms' medical affairs professionals, who are exploring ways to keep themselves relevant while embracing the unprecedented technology, DIA China hears.

Artificial Intelligence China Digital Health

Clinical Trial Reform

‘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

Read more Pink Sheet stories about clinical trials...

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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


Multimedia

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

As Biosecure Bill Moves 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
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

Korea’s Clinical Trial Approvals Up 10%, But Still Below Pandemic Peak

South Korea’s clinical trial approvals rebounded in 2023, but remained lower than the peak levels in 2020-21 amid then robust R&D activity related to COVID-19. Last year's tally showed a mix of single-country and multinational trials and reflected the ongoing dominance of oncology in industry pipelines.

South Korea Clinical Trials

Vaccine Star's Surprise Downfall Indicative Of Trouble In China’s COVID Push?

Apparently months after his actual detention, news has finally surfaced that a key researcher behind China's rapid development of a homegrown COVID-19 vaccine is said to have "severely violated" Communist Party rules and regulations and is the subject of a probe for possible corruption.

China Policy

Pink Sheet Podcast: Clinical Trial Reg Issues, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock

Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.

Clinical Trials Pricing Debate

Pediatric Study Plans Should Be Made Public, FDA’s Oncology Advisers Say

The push for more transparency so researchers are not unnecessarily duplicating or competing for the same small pool of patients raises a problem that goes beyond the RACE Act, FDA officials said.

Clinical Trials Pediatrics

US FDA Focuses On Labs, Concomitant Medication To Avert Needless Clinical Trial Exclusions

The FDA is pushing sponsors away from template exclusion criteria to highly tailored drug- and trial-specific eligibility requirements in order to widen the patient pool eligible for studies.

Clinical Trials Guidance Documents

340B Contract Pharmacy Confusion: Another US Court Sides With Pharma, States Enact Roadblocks

The DC Circuit Court agrees with an earlier appeals court ruling that the law does not prohibit manufacturers from setting the terms of their 340B outpatient drug discounts to contract pharmacies.

Legal Issues Pricing Strategies

Novel Antimicrobials: Firms Urged To Draw Up Access & Stewardship Plans For Lower-Income Countries

Pharma firms have a set of tools and strategies at their disposal to ensure access to new antimicrobials while safeguarding their effectiveness, but companies developing some of the most promising drug candidates are not making the most of these tools, according to a new report.

International Research & Development

Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials

The plan is to create a single platform that would facilitate rapid and streamlined clinical trial approvals and address the challenges sponsors currently face in having to navigate different processes for clinical trials in each state and territory, and within area health services.

Australia Clinical Trials

Deadline Nears For Comments On WHO’s Proposed Requirements For MAbs Targeting RSV

The World Health Organization has developed a draft addendum to its 2023 guideline on the evaluation of mAbs intended for the prevention or treatment of infectious diseases, focusing on supplementary aspects specific to respiratory syncytial virus disease.

International Biologics

Novo’s Insulin Icodec: Hypoglycemia Events In Type 1 Diabetics Put Broad Indication At Risk

A US FDA advisory committee will consider whether the benefits of once-weekly insulin icodec outweigh the significantly higher rate of hypoglycemic episodes in patients with type 1 disease. The agency appears satisfied with safety and efficacy in type 2 diabetics.

Advisory Committees Drug Review

NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional

Proposed rule would not require price concessions in the interest of balancing enhanced access with protecting the ‘viability and sustainability of a product’ in the market.

Policy Research & Development

Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach

Energy and Commerce Committee member suggests CBER now is more flexible with rare disease product approval requirements than CDER, inviting the drug center to return to its approach under former director Janet Woodcock.

Rare Diseases Review Pathway
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