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US FDA Oncology, Device Centers Developing Public Diagnostic Standards

Pilot program would get around the ‘one drug, one test’ policy, which has created intellectual property issues.

Cancer Diagnostics

CSL’s Hemgenix Gene Therapy Does Not Need A REMS, FDA Tells National Hemophilia Foundation

Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the label cite eligibility criteria used in clinical trials, responding to a citizen petition on the day the agency approves the therapy.

Gene Therapy Drug Safety

AAM CEO Leonard Departs After Two Years, Creating Another Trade Group Searching For New Leader

David Gaugh, AAM’s executive VP of sciences and regulatory affairs, was named the interim CEO, making him the fourth person to run the association since February 2020.

Generic Drugs Leadership

To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of Demand Spike

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

Supply Chain Manufacturing

Eisai Plots A Meticulous Path To Medicare Coverage For Lecanemab

Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.

Reimbursement Medicare

US FDA’s Non-Cancer Accelerated Approval Drugs Get Their Own Public Databases

Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.

Review Pathway Post Market Regulation & Studies

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

Advisory Committees Drug Review

Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme

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

US FDA Performance Tracker Approvals

Pharma Could Face Fewer False Claims Act Suits If Supreme Court Concurs With Government

High court is to determine whether the government can dismiss an FCA complaint after initially declining to take it on. In recent years, the government has dismissed numerous qui tam suits against pharma companies in which it did not intervene.

Enforcement Medicaid

Obesity Drug Coverage In ACA Plans May Expand With Shift In Treatment Classification Standard

Current drug classification standard was originally designed for the Medicare Part D program, which does not cover obesity drugs.

Regulation Reimbursement

Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur

Biotech sponsors understandably discuss accelerated approval as an important consideration in development plans. But the head of the US FDA oncology program has a reminder for them: the pathway is intended to serve patients – not drug companies.

Drug Approval Standards Review Pathway

Gilead Wins Breach Of Contract Suit Against CDC But Damages, Patent Dispute Are Unresolved

Court finds government failed to promptly notify Gilead of its PrEP-related patent applications as required under agreements for supply of HIV drugs used in CDC studies. Whether Gilead will have to license government patents remains undecided.

Intellectual Property Legal Issues
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