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COVID-19 Vaccine Authorization In Adolescents Would Raise Questions Around Routine Immunizations

US FDA not planning an advisory committee for Pfizer/BioNTech’s request for authorization in 12-15-year olds at this time, but CDC’s ACIP is likely to weigh how to balance timing of COVID vaccination with administration of other immunizations generally recommended for adolescents.

Coronavirus COVID-19 Vaccines Advisory Committees

Gilead Assistance Programs For HIV, Hep B Drugs Will Dial Back Reimbursement To 340B Providers

HIV community is pushing back against the change, arguing that revenue lost from reduced reimbursement will cripple providers, which use the extra funds for wrap-around patient support and services.

Pricing Strategies Infectious Diseases Advertising, Marketing & Sales

Pharma’s Upcoming Messaging Battles In US Pricing Debate Foreshadowed In CBO Report

Our infographic offers the top takeaways from Congressional Budget Office report that says lower drug prices would decrease industry’s spend on research and development, while rejecting claim that costs of R&D set or impact a particular medicines price.

Pricing Debate Research & Development Legislation

Spotlight On Coronavirus

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Pink Sheet Podcast

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

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Click to read Six Themes That Will Shape Biopharma In Transformational 2021

Key Predictions From Industry Leaders

 

 

 

Performance Trackers

Keeping Track: US FDA Clears Another CAR-T And Another Novel ADHD Drug; Submissions Blossom

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

Approvals Drug Review ImmunoOncology

Global Pharma Guidance Tracker – March 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

Set Alert for Policy & Regulation

Latest From Regulation

Biden Leaves US FDA Largely Out Of Budget Outline

FDA is only mentioned once in the document, and its temporary leadership may not be the reason why.

FDA Legislation

Pink Sheet Podcast: EUA’s Impact On US FDA, March-In Rights, CBER And Real-Time Oncology Review

Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.

Coronavirus COVID-19 Review Pathway

Coronavirus Notebook: EMA Probes Janssen Vaccine Blood Clot Reports, UK Advises 12-Week Dosing Gap For Moderna

The AZ vaccine is now under EU scrutiny over capillary leak syndrome, while Valneva has reported positive results with its product. The global COVAX initiative has delivered more than 38 million doses of vaccines to over a hundred countries. 

Europe United Kingdom

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

PDUFA VII Could Increase Transparency Of REMS Release Process

Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.

User Fees Risk Management

US FDA Exploring Options To Improve Study Of Drugs In Elderly

New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.

Research & Development Drug Approval Standards

Latest From Policy

Higher Medicaid Rebates For Expedited Approvals Offer Modest Savings But Target Growing Concern

As MACPAC moves toward formal recommendations, a CBO analysis finds that differential Medicaid rebates for drugs approved through the accelerated pathway could save the federal government up to $1bn over five years.

Pricing Debate Medicaid

Biden Administration Will Back New Health Research Contracting Agency

Upcoming budget proposal likely to include a proposal for funding of a DARPA-like contracting entity. Any focus on innovations and breakthroughs is likely welcome news for industry – though perhaps not the message that government is taking on work that drug companies can’t or won’t do.

Research & Development Politics

Pharma Pushes For Stronger ‘March In’ Rule Despite Changing Political Dynamics, COVID Complications

With COVID-19 drawing new attention to the government’s investment in R&D and high drug prices, lower drug pricing advocates are optimistic the Biden team will a Trump-era attempt to carve out a medication’s price from patent breaking criteria. The drug industry isn’t just defending Trump’s plan – its trying to strengthen it.

Intellectual Property Pricing Debate

Clinical / R&D Explore this Topic

Set Alert for Clinical R&D

Latest From Research & Development

US FDA Exploring Options To Improve Study Of Drugs In Elderly

New incentives will most likely not be the immediate focus, but working group to explore ideas on enhancing understanding of drug effects in elderly populations will likely be formed by US FDA.

Research & Development Drug Approval Standards

Biden Administration Will Back New Health Research Contracting Agency

Upcoming budget proposal likely to include a proposal for funding of a DARPA-like contracting entity. Any focus on innovations and breakthroughs is likely welcome news for industry – though perhaps not the message that government is taking on work that drug companies can’t or won’t do.

Research & Development Politics

5 Steps To Mastering Global Clinical Trial Disclosure Compliance

Clinical trial disclosure compliance must include identification and documentation of registry requirements, key stakeholders, company policies, systems, and processes.

Clinical Trials Compliance

Commercial Explore this Topic

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Latest From Commercial

Pharma Pushes For Stronger ‘March In’ Rule Despite Changing Political Dynamics, COVID Complications

With COVID-19 drawing new attention to the government’s investment in R&D and high drug prices, lower drug pricing advocates are optimistic the Biden team will a Trump-era attempt to carve out a medication’s price from patent breaking criteria. The drug industry isn’t just defending Trump’s plan – its trying to strengthen it.

Intellectual Property Pricing Debate

Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups

Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.

Drug Review Complete Response Letters

Diabetes, Blood-Thinners Dominate Copay Support, But Assistance May Not Be Well Targeted To Need

New comprehensive study of drug coupons offered by manufacturers, pharmacies, pharmacy benefit managers and state programs, and who uses the discounts, takes a more holistic look at patient assistance programs than previous work. Researchers raise concerns that the offsets don’t seem well targeted at people with high financial or clinical need. 

Pricing Debate Private Payers

Manufacturing Explore this Topic

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Latest From Manufacturing

Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps

Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.

Manufacturing Quality

Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable

Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

Quality Compliance

Biden Infrastructure Plan Would Boost Pandemic Preparedness, Biotech R&D, US Manufacturing

Tax hike would fund $30bn for pandemic preparations and billions more for biotech R&D and rural manufacturing jobs that are part of comprehensive infrastructure renewal proposal.

Manufacturing Research & Development
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