Pharmaceutical Regulatory Affairs | Compliance| Pink Sheet

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With a network of journalists and analysts crisscrossing the globe, our industry experts and thought leaders track product progress from submission to approval. We also draw on the strength and expertise of the rest of the Pharma Intelligence family of analytical and market intelligence tools.

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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.

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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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Drug Pricing eBook

25 May 2021

Tap into expert coverage of the complex world of drug pricing with insights from analysts at Scrip and Pink Sheet. This eBook includes vital information about issues affecting drug pricing for the US, EU, and other global markets, including patient access, regulatory issues, commercial challenges, value-based pricing, and more.

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Manufacturing and Distribution: Challenges and Opportunities

13 May 2021

The COVID-19 pandemic has brought about significant manufacturing and distribution challenges and opportunities for Pharma. Seize new opportunities and avoid risk with the strategic commercial and regulatory intelligence you need to stay competitive by subscribing to Pink Sheet and In Vivo.

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US COVID Vaccine Patent Waiver Is Big, Symbolic Blow For Pharma, But The Fight Is Just Beginning

By Sarah Karlin-Smith 06 May 2021

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Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.

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Long-Awaited EU Clinical Trials Portal Meets Major Milestone

By Vibha Sharma 22 Apr 2021

A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.

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Sputnik V COVID-19 Vaccine Causing A Stir In The EU

By Ian Schofield 08 Apr 2021

The team behind Sputnik V has attacked what it calls “fake news and provocations” in the EU as political arguments over the vaccine claim another ministerial scalp.

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