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Pfizer’s Latest Palbociclib Data Could Mean Slimmer Lead Over CDK4/6 Rivals

 
• By Emily Hayes

Final Phase II data for palbociclib in breast cancer at AACR meeting raise questions about prospects for accelerated approval prior to Phase III results. Meanwhile, Lilly’s bemaciclib emerges as potent monotherapy with seemingly lower risk for neutropenia, but more data are needed to flesh out the drug’s profile.

Data released at the American Association for Cancer Research meeting cast doubt on prospects for accelerated approval of Pfizer Inc.’s palbociclib in advanced breast cancer and highlighted the potential strengths of an emerging earlier-stage competitor in the same class – Eli Lilly & Co.’s bemaciclib.

In final data from the Phase II PALOMA-1 study of first-line advanced breast cancer released April 6 at AACR’s annual meeting, once-daily palbociclib in combination with the aromatase inhibitor letrozole...

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

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Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.