Pharmaceutical Regulatory Affairs | Compliance| Pink Sheet

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Pink Sheet

What Breast Cancer Drug Developers Need to Know Now About Regulatory Policies

21 Oct 2022

As biopharma continues to make progress developing novel and more targeted cancer therapies, regulators are responding with innovative and collaborative approaches to reviewing cancer products, aiming to resolve questions earlier and review products more quickly. Pink Sheet closely covers these programs, helping readers understand the expectations, challenges and opportunities, as well as lessons from companies putting policy into practice. This ebook takes some of our recent articles on special review mechanisms and regulators’ data expectations.

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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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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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Download your free accelerated trials article pack for insights into the latest developments

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

By Brenda Sandburg 03 Aug 2021

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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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Global Regulatory Harmonization Discussions Ongoing About COVID-19 Vaccine Boosters

By Derrick Gingery 14 Jul 2021

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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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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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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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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.