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Featured Stories



Copay Accumulator Lawsuit Comes To An End; Will Ruling Be Enforced?

The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court ruling after HHS stops its appeal. As groups that brought the suit press CMS for guidance, they also eye complaints with DOL and class-action suits.

PBMs Reimbursement Legal Issues

Pooled Procurement Of Cancer Drugs In India: Is Pharma Game For More?

India’s National Cancer Grid pilots pooled procurement for 40 drugs including trastuzumab, imatinib, and pemetrexed, delivering median savings of over 80%. Experts discuss with Scrip the prospects of scaling the initiative and what it may mean for pharma’s margins and go-to-market strategy.

Reimbursement India Cost Effectiveness

New US FDA Genetic Metabolic Adcomm Needs More Candidates

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

Advisory Committees Rare Diseases Regulation

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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

Keeping Track: Iovance’s Amtagvi Approval Brings T Cell Therapy To Solid Tumors

Melanoma treatment Amtagvi is US FDA’s biologics center’s first novel approval of 2024.

Gene Therapy Biologics Approvals

Global Pharma Guidance Tracker – January 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

Gene Therapy: US FDA Willing To Accept Single-Arm Trials For Approval, But Sponsors May Hesitate

Data indicates a smaller percentage of studies intended for product registration or indication expansion are single-arm trials, compared to the proportion for all gene therapy trials.

Gene Therapy Clinical Trials

Expanded Access: US FDA Application Data Suggest More Project Facilitate Outreach Needed

Academic medical centers still submit the vast majority of applications to the FDA Oncology Center of Excellence’s expanded access program, suggesting many community hospitals and other providers may perceive barriers to the program.

Cancer Market Access

FDA’s Dry January: Little Novel Application Activity, But That Doesn’t Mean No Fun

US FDA’s drugs center posted one of its lowest monthly approval counts of original applications in January, but new indications filled the gap, including new claims for Merck’s Keytruda, Takeda immunoglobulins, and Sanofi/Regeneron’s Dupixent.

US FDA Performance Tracker Approvals

Time To Tip the Scales? Humira Biosimilars And The Limitations Of Competition In US Health Care

In year two, Humira biosimilar uptake – or the lack thereof – continues to build the case for policy reform to incentivize use of cheaper biologics in the outpatient setting.

Biosimilars Reimbursement
Regional Comparisons

FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake

While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.

Generic Drugs Regional Comparisons

Regulatory Reliance Pathways: Challenges And Opportunities Ahead

International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”

BioPharmaceutical Drug Review

Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

BioPharmaceutical Market Access

Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests

European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.

Regional Comparisons Drug Review
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Recent Stories

From COVID Cliff To GLP-1 Ramp: Novo Takes Catalent Plants For Next Public Health Crisis

A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.

Manufacturing Supply Chain

FDA Cancer Center’s New ‘Projects’ Focus On Early Endpoints; Asian American, Native Hawaiian Populations

Launched in 2023, Project Endpoint focuses on advancing understanding of early, novel endpoints, while Project ASIATICA aims to bring greater awareness of challenges and health disparities faced by Asian American, Native Hawaiian, and Other Pacific Islander patients with cancer.

Clinical Trials Drug Approval Standards

English & Scottish HTAs Diverge On Sanofi’s Dupixent For Rare Skin Condition

The Scottish health technology appraisal body, the SMC, has announced its recommendations on Sanofi’s Dupixent, Ipsen’s Cabometyx, Sobi’s Zynlonta and Novartis’ Cosentyx.

Europe United Kingdom

French Agency Sets Up New Body To Advise On Biosimilar Substitution

The new committee, which will initially be in place for a year, will advise the French drug regulator when it is preparing its opinions on substitution in specific biosimilar product groups.

Europe France

Pink Sheet Podcast: Price Negotiation Suit Tossed, Drug Shortage Probe, FDA-Approved Marijuana

Pink Sheet reporters and editors discuss the dismissal of PhRMA’s suit challenging the Medicare price negotiation provisions, the US FTC and HHS investigation of drug shortages, and the potential for FDA-approved marijuana products.

Pricing Debate Generic Drugs

CMS Expects Part D Plans To Go To Great Lengths Facilitating Participation In New Copay ‘Smoothing’ Option

The Medicare draft guidance seems designed to ensure seniors don’t miss out on the IRA benefit. 

Medicare Reimbursement

Senators Pressure US FDA To Issue New Guidance On Social Media Drug Promotion

Senators ask the agency to address the “regulatory loophole” permitting telehealth companies to promote prescription drugs without disclosing side effects and question if FDA has enforcement authority over third-party social media influencer promotions.

Advertising, Marketing & Sales Enforcement

Outlook To Make Its Case For Ophthalmic Bevacizumab At High-Stakes EMA Meeting

Outlook Therapeutics is hoping to secure EU marketing approval for the first ophthalmic formulation of bevacizumab.

Europe Ophthalmic

AstraZeneca’s Danicopan Among Four Orphans Up For EU Approval Decision

The European Medicines Agency is due to decide whether to back pan-EU marketing authorization for 11 new products, including four orphan drugs.

Europe Approvals

Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications

The contentious issue of data exclusivity came to the fore during the European Free Trade Association's negotiations with India for a Free Trade Agreement. What are the arguments in support and against, including impact on compulsory and voluntary licensing?

Policy Intellectual Property

Philippines FDA Slashes Approval Timelines For Generic Drugs

The Philippines Food and Drug Administration is set to shorten the timeline for generic review and approval from 120 days to just 45 days, as part of efforts to register new generics and bring down prices.

Regulation Policy

England’s NICE Unconvinced That Sanofi’s Sarclisa Is Cost Effective After Cancer Drugs Fund Review

Sanofi says it will engage further with NICE after the health technology assessment body rejected Sarclisa for previously-treated multiple myeloma, and that it is “hopeful a way forward can be found.”

Europe Germany
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