Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.

July 26, 2024

Vol.50 No.30

By Jacquelyn Cobb and Paul Goldberg

Clinical Roundup

New payment code and Medicare payment implemented for AI cancer imaging device

Avenda Health, an AI healthcare company, announced the Centers for Medicare & Medicaid Services has assigned a national payment rate for the company’s innovative prostate cancer mapping technology, Unfold AI.

July 26, 2024

Vol.50 No.30

Drugs & Targets

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.

July 26, 2024

Vol.50 No.30

Drugs & Targets

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.

July 26, 2024

Vol.50 No.30

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.

Proposed rule by CMS would expand access to cancer treatment at tribal facilities

The Centers for Medicare and Medicaid Services said it intends to start providing additional reimbursement for some high-cost drugs for people with Medicare who receive care at Indian Health Service or tribal hospitals, beginning Jan. 1, 2025.

July 19, 2024

Vol.50 No.29

By Jacquelyn Cobb

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

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ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

New payment code and Medicare payment implemented for AI cancer imaging device

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

Proposed rule by CMS would expand access to cancer treatment at tribal facilities

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Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

YOU MAY BE INTERESTED IN

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

New payment code and Medicare payment implemented for AI cancer imaging device

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

Platinum drugs are off the shortage list, but the underlying problem is unsolvedFDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

Proposed rule by CMS would expand access to cancer treatment at tribal facilities

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Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”