FDA grants orphan drug designation to Heidelberg Pharma agent for MM

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.

FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

FDA granted Fast Track designation for Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.xxx:more

July 12, 2024

Vol.50 No.28

Judiciary News Analysis

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.

July 05, 2024

Vol.50 No.27

By Matthew Bin Han Ong

Conversation with The Cancer Letter

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

The Supreme Court struck down the Chevron doctrine, removing one of the foundational principles of administrative law and upending the way federal agencies rely on technical subject-matter expertise. What comes next?

July 05, 2024

Vol.50 No.27

By Matthew Bin Han Ong

Drugs & Targets

FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC

FDA granted Fast Track designation to Syncromune Inc., a clinical-stage biopharmaceutical company, for SYNC-T SV-102 therapy, Syncromune’s lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer.

July 05, 2024

Vol.50 No.27

White House

At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

Leaders of three health agencies presented new initiatives focused on patient-centered research, diversity in clinical trial enrollment, and innovation in clinical research.

June 28, 2024

Vol.50 No.26

By McKenzie Prillaman

FDA grants orphan drug designation to Heidelberg Pharma agent for MM

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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.”

FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

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

FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC

At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

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FDA grants orphan drug designation to Heidelberg Pharma agent for MM

YOU MAY BE INTERESTED IN

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.”

FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

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

FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC

At White House forum, Bertagnolli, Califf, Wegrzyn call for greater innovation in clinical trials

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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.”