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Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Drug Review Clinical Trials

Roxadustat Rejection Has Lessons For Other Sponsors

A US FDA Advisory Committee’s overwhelming rejection of FibroGen/AstraZeneca’s oral anti-anemia agent is a big setback for the sponsor. But the committee’s reaction to novel strategies used to try to save the application has an important message for all drug developers about the limits of those approaches.

Advisory Committees Clinical Trials

Janssen’s COVID-19 Vaccine Should Continue To Be Available, CDC Panel Concurs

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

Advisory Committees Coronavirus COVID-19

Interchangeable Biosimilars: Insulin Likely First But Humira May Be More Important Precedent

US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Biosimilars Reimbursement

Drug Pricing Reform As Legislative ‘Pay For’ Gaining Momentum But What About Part D Redesign?

Association for Accessible Medicines makes a case for lowering prices in Part D through benefit design reforms enabling quicker and better access to first generics.

Pricing Debate Medicare

J&J, Distributors May Be Free Of Opioid Litigation If Enough States Sign On To $26bn Settlement

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

Legal Issues Advertising, Marketing & Sales

When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval

More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.

Drug Review Review Pathway

Price Negotiation In Part D: Big Savings On Revlimid, Ibrance, Xtandi Projected in CAP Analysis

As Democrats in the US Congress work to move legislation empowering the Health and Human Services Department to negotiate drug prices directly with manufacturers, the Center For American Progress releases an analysis on which drugs would be targeted by House bill HR 3 and how much prices could be reduced.

Pricing Debate Legislation

Cancer Trials Should Focus On Collecting Data ‘Strictly Necessary’ For Assessing Efficacy

In journal article, leaders from academia, industry, NCI and FDA propose building upon pandemic-necessitated flexibilities in clinical research, including making it easier for trial participants to access investigational drugs in their own communities and reduced reporting of uninformative adverse events.

Clinical Trials Coronavirus COVID-19

Ardelyx’s Tenapanor Hits Another Regulatory Stumbling Block On Label, Post-Marketing Commitments

While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.

Drug Review Regulation

Aduhelm Invades Senate Committee’s COVID-19 Hearing

Woodcock again defends the decision, saying Congress intended accelerated approval for those situations.

Politics Neurology

Wait For Stability Results Before Moving Expiring COVID-19 Vaccine, Woodcock Says

Acting FDA Commissioner Janet Woodcock says stability studies are ongoing and that states shouldn’t get rid of expiring inventory yet.

Coronavirus COVID-19 Vaccines
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