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Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors

Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’

Review Pathway Clinical Trials

Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular

The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.

Generic Drugs Intellectual Property

US FDA Works To Stay Ahead Of Benzodiazepine Misuse

FDA and NIH are looking to spark research on approaches to reduce use of benzodiazepines and to help mitigate issues with withdrawal associated with the widely prescribed therapies.

Drug Safety Post Market Regulation & Studies

CDC Vaccine Advisors Must Fill In Missing Holes On Pfizer’s COVID Booster Plan

ACIP will get a chance to further restrict and tailor the US booster plan for COVID vaccinations. Among other things, CDC's advisors may have to define what constitutes being at high risk of severe COVID-19 post-primary vaccination, occupations at high risk of COVID exposure, and whether people who didn’t receive Pfizer’s primary vaccine series could get the company’s mRNA booster shot.

Vaccines Advisory Committees

Back to The Past: The Case for Improving Upon, Not Throwing Out Traditional Cancer Phase I Study Designs

US FDA has pushed sponsors away from the traditional dose-finding designs for cancer drugs in recent years. But academics continue to make a case for keeping the 3+3 design with some improvements.

Clinical Trials ImmunoOncology

Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

US FDA Performance Tracker Drug Review

A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created

Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.

User Fees Manufacturing

US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot

Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population. 

Advisory Committees Coronavirus COVID-19

COVID-19 Vaccine ‘Booster’ Or Simply A Third Dose? US FDA’s Marks Starts To Reframe The Issue

It’s a classic example of an internal dispute between an FDA review team and agency leadership playing out at an advisory committee forum, except with the highest possible stakes.

Coronavirus COVID-19 Vaccines

Improper Dose In Phase II Trials Can ‘Make Or Break’ Drug Program, FDA’s Stein Says

Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.

Clinical Trials FDA

340B Hospitals Charging Private Insurers Nearly Four Times Acquisition Costs On Cancer Drugs – Study

New report makes a case for further scrutiny of the 340B program's contributions to high drug costs, although manufacturers remain the main target of legislative and regulatory reform proposals.

Pricing Strategies Reimbursement
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