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Pink Sheet: global policy and regulatory coverage

Inform your strategic decisions with unparalleled access to worldwide pharmaceutical regulatory affairs and compliance-related intelligence. Rely on the exclusive industry expertise of Pink Sheet.

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Our team of global contributors helps you to anticipate challenges, minimize risks and maximize opportunities. Pink Sheet is the biopharma industry’s go-to source for business-critical insights and policy and regulatory intelligence.

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Pink Sheet

Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

By Bridget Silverman 19 Jan 2022

US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.

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Pink Sheet

Care Needed With Plain Language Summaries Of EU Study Results

By Vibha Sharma 18 Jan 2022

The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.

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07 Dec 2021

Don’t miss updates on recent news in accelerated trials and its implications for drug development in the United States.

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Pink Sheet

Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

By Brenda Sandburg 01 Dec 2021

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

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Pink Sheet

11 Going On 12: CDC Panel Pays Special Attention To Kids Caught In Middle Of Pfizer/BioNTech Vaccine Dose Increase

By Sue Sutter 03 Nov 2021

Whether a child receives the 10 mcg dose of COVID-19 vaccine authorized for 5-11 year-olds or the 30 mcg dose authorized for ≥12 year-olds should be based on age on day of vaccination, CDC says, but FDA is allowing some dosing flexibility for kids who celebrate their 12th birthday in the middle of the primary series.

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Pink Sheet

Moderna COVID-19 Vaccine: Booster Study Hits Only One Of Two Immunogenicity Endpoints

By Sue Sutter 13 Oct 2021

Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

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Pink Sheet

CureVac Pulls Covid Vaccine From European Review Process

By Francesca Bruce 12 Oct 2021

The company behind the CVnCOV COVID-19 vaccine candidate says the decision to withdraw from regulatory review is strategic. The EMA says outstanding issues affecting the benefit-risk balance remained to be answered at the time of withdrawal.

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Pink Sheet

AVEO’s Fotivda: US FDA Concerns About Overall Survival Put To Rest By TIVO-3 Final Analysis

By Sue Sutter 16 Aug 2021

After repeatedly advising against tivozanib NDA submission on the basis of interim overall survival data that suggested a negative trend, agency ultimately concluded the final analysis did not suggest a detrimental effect in third-line renal cell carcinoma even though median overall survival was shorter than for the comparator agent, Bayer’s Nexavar.

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Pink Sheet

Expectations Are High But What Precisely Will England’s New IMF Deliver?

By Leela Barham 03 Aug 2021

The Innovative Medicines Fund, due for launch in England later this year, may provide industry with an opportunity to hold key public bodies to account.

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Pink Sheet

Merck, Pfizer Pneumococcal Vaccines: More Serotype Protection Vs. Pneumonia Indication

By Brenda Sandburg 03 Aug 2021

Ahead of CDC advisory committee this fall, Merck highlights additional bacteria serotypes its Vaxneuvance protects against while Pfizer touts Prevnar 13’s indication for pneumonia.

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Pink Sheet

Global Regulatory Harmonization Discussions Ongoing About COVID-19 Vaccine Boosters

By Derrick Gingery 14 Jul 2021

US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.

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Pink Sheet

COVID-19 Causes Further Delay To Canada’s Controversial Pricing Reforms

By Francesca Bruce 30 Jun 2021

A delay to implementing drug pricing reforms is an opportunity for Canadian authorities to come up with better proposals, say industry representatives, while authorities remain adamant that action is necessary to lower prices.

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Pink Sheet

Woodcock Attributes Aduhelm Approval Controversy To ‘Process Problems’

By M. Nielsen Hobbs 23 Jun 2021

US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.

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Pink Sheet

US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion

By Sarah Karlin-Smith 16 Jun 2021

CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.

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Pink Sheet

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

By Sue Sutter 08 Jun 2021

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

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Pink Sheet

24 Jan 2022

Coronavirus Notebook: Australia OKs Paxlovid, Lagevrio & Nuvaxovid, New Sputnik Data Show ‘Strong Protection’ Against Omicron

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24 Jan 2022

COVID-19 Redefining Clinical Trial Transparency Expectations & Challenges

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23 Jan 2022

The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations

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21 Jan 2022

IP Questions Could Dog The WHO's BioHub Pandemic Project

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21 Jan 2022

Better Discount To Bylvay £255,000 List Price Sways England’s NICE

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21 Jan 2022

Hits, Misses & Key Firsts For EMA’s PRIME Scheme

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20 Jan 2022

Robotic Aseptic Filling Could Help Production, But Faces Regulatory Inconsistency

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20 Jan 2022

Paxlovid Prescribing Complicated By Dosing Adjustment For Renal Impairment, Drug-Drug Interactions

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20 Jan 2022

Merck/Ridgeback’s COVID-19 Drug Molnupiravir Met EUA Bar, But More Data Needed For Full Approval – US FDA

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20 Jan 2022

European Parliament Signs Off Regulation To Tackle Medicine Shortages

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20 Jan 2022

Pfizer’s COVID-19 Vaccine Data In Young Children Could Place US FDA In Awkward Position Again

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Pink Sheet

19 Jan 2022

EMA: Multiple COVID-19 Booster Programs ‘Not Sustainable’ In Long Term

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19 Jan 2022

Paxlovid, Molnupiravir Access Threatened By ‘Dismal' Pharmacy Dispensing Fees, CMS Told

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19 Jan 2022

Califf Confident Public Trust In US FDA Will Be Rebuilt

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19 Jan 2022

EU Extends Provisions For Ensuring Post-Brexit Flow Of Medicines

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Meet the team

Editor

Brenda Sandburg

Editor, Senior Editor

New York, USA

Brenda specializes in

Policy & Regulation
Biosimilars
Biotech
Generics
Pricing & Reimbursement

39+ years of experience

Editor

Cathy Kelly

Editor, Senior editor

Washington DC, USA

Cathy specializes in

Policy & Regulation
Market Intelligence
Market Access
Pricing & Reimbursement

39+ years of experience

Management

Denise Peterson

Management, Editor In Chief, Pharma US

Washington DC, USA

Denise specializes in

Commercial Strategy
Policy & Regulation

38+ years of experience

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Pink Sheet: global policy and regulatory coverage

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Brenda Sandburg

Editor, Senior Editor

Cathy Kelly

Editor, Senior editor

Denise Peterson

Management, Editor In Chief, Pharma US

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