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FDA’s Pazdur: Accelerated Approval Is ‘Under Attack,' Supporters Can’t Afford To Remain Silent

US FDA’s Oncology Center of Excellence Director and the National Institutes of Health National Cancer Institute Director defended the agency’s accelerated approval pathway, saying critics are missing the benefits reaped by many cancer patients. Pazdur worries pathway is at risk, unless champions work to counter critics.

United States Drug Approval Standards FDA

US FDA Doesn’t Need Conditional Approval Pathway, Cavazzoni Tells House Committee

CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.

Neurology Politics Research and Development Strategies

With Interchangeability Nod, Viatris' Semglee Loses Its Identity

Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.

Biosimilars Approvals Review Pathway

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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: US FDA Clears Bylvay, Fexinidazole, Gives Retifanlimab CRL; JAK Inhibitor Class Delays

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals Drug Review


Global Pharma Guidance Tracker – June 2021

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

Policy & Regulation Explore this Topic

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Latest From Regulation

Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims

In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.

Advertising, Marketing & Sales Enforcement

US FDA Publishes, Then Withdraws, PDUFA Rates Because Process ‘May Not Be Well Understood’

User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.

User Fees Review Pathway

Pink Sheet Podcast: First Interchangeable Biosimilar, Alzheimer’s At CMS, COVID-19 Vaccines In Kids

Pink Sheet reporters and editors discuss Viatris receiving the first interchangeable biosimilar designation, CMS hearing from stakeholders about Aduhelm and other Alzheimer’s drugs, and concerns about expanding pediatric coronavirus vaccine trials to look for rare adverse events.

Biosimilars Vaccines

JAK Inhibitor Safety Concerns vs Rebates: Which Will Impact Atopic Dermatitis Drug Access More?

ICER discussion on the health benefit of several upcoming drugs for atopic dermatitis, including several JAK inhibitors, touches on safety concerns and the likelihood that increased competition will open the door to higher list prices and rebating in the class.

Regulation Reimbursement

EU Accelerated Assessment Tracker

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, five requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

Europe Review Pathway

Recent And Upcoming FDA Advisory Committee Meetings

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

Advisory Committees Drug Review

Latest From Policy

JAK Inhibitor Safety Concerns vs Rebates: Which Will Impact Atopic Dermatitis Drug Access More?

ICER discussion on the health benefit of several upcoming drugs for atopic dermatitis, including several JAK inhibitors, touches on safety concerns and the likelihood that increased competition will open the door to higher list prices and rebating in the class.

Regulation Reimbursement

Bills To Speed Generic Entry Once Again Clear Senate Judiciary Committee

Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.

Legislation Pricing Debate

Dutch HTA Body Hits Out At Bluebird’s Zynteglo Pricing

The Netherlands calls for multi-country price negotiations for gene therapy Zynteglo.

Europe Belgium

Clinical / R&D Explore this Topic

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Latest From Research & Development

Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Drug Review Clinical Trials

Accelerated Approval Of Lilly’s Alzheimer’s Drug Could Last About 15 Months, CEO Says

Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.

Clinical Trials Drug Approval Standards

China Signals Further Clinical Trial Policy Tightening

The nation’s top drug regulator vows to adopt ICH’s guidelines on drug safety and efficacy, after dropping the industry a bombshell with the tightening of oncology drug clinical trials a week ago.

China Clinical Trials

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Latest From Commercial

The Indemnity Calculus For Covid-19 Vaccines, India’s Path Ahead

Legal experts discuss the intricacies around pharma’s demand for indemnity, a key sticking point for supplies of COVID-19 vaccines from Pfizer and Moderna, and the path forward for countries like India.

Commercial Coronavirus COVID-19

Merger Scrutiny A Bigger Risk To Pharma Than Drug Price Reform, Orzag Predicts

US antitrust regulators appear poised to take a broader view of disease areas when reviewing mergers, Lazard Freres financial advisory CEO Peter Orszag cautioned.

Pricing Debate M & A

Sanofi/Merck Launch First 6-In-1 Combo Vaccine In US After Two-And-A-Half Year Supply Buildup

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

Vaccines Launches

Manufacturing Explore this Topic

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Latest From Manufacturing

EMA Seeks To Clarify Similarity Assessment

The European Medicines Agency has updated its reflection paper on methodologies for comparative quality assessment. The paper clarifies expectations on the assessment of similarity for manufacturing changes and for generic and biosimilar development by introducing the concept of “similarity condition.”

Quality Biosimilars

Time Is Now To Seek US Funding, Financing To Expand Domestic COVID-19 Vaccine Supply Chain

BARDA and Development Financing Corp. officials provide insights into window of opportunity for partnering on manufacturing scale-up.

Coronavirus COVID-19 Vaccines

Waiting For Inspections, Biocon Seeks US FDA Stance On Mutual Recognition Agreement Route

Biocon needs a pre-approval inspection for insulin aspart at its facility in Malaysia, but the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Manufacturing Biosimilars
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