STAT

JUNE 10, 2023

The government’s top addiction scientists and key public health officials are calling for more research into fentanyl test strips. Amid a devastating overdose epidemic, the U.S. must ensure that test strips are legal and widely available, the officials wrote in a New England Journal of Medicine perspective published Saturday. Additionally, they argued, the U.S. should work to develop new products and technologies that facilitate drug-checking.

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FDA 100

Drug Topics

JUNE 10, 2023

Your weekly roundup of the latest news from Drug Topics®.

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pharmaphorum

JUNE 10, 2023

FDA panel gives unanimous support to Leqembi Phil.

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FDA 97

Pharmaceutical Technology

JUNE 10, 2023

RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. According to GlobalData, Phase II drugs for Hyperinsulinemia does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RZ-358 LoA Report.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

STAT

JUNE 10, 2023

WASHINGTON — The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts. The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning.

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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report.

Vaccines 40

Vaccines Immunization Hospitals 40

Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. According to GlobalData, Phase I drugs for Brain Tumor does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the CIGB-128 LoA Report.

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Pharmaceutical Technology

JUNE 10, 2023

TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the TAS-117 LoA Report.

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Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report.

Chemotherapy 40

Chemotherapy 40

Pharmaceutical Technology

JUNE 10, 2023

NuGel is under clinical development by Shaperon and currently in Phase I for Sepsis. According to GlobalData, Phase I drugs for Sepsis does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the NuGel LoA Report. Buy the report here.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Pharmaceutical Technology

JUNE 10, 2023

RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. According to GlobalData, Phase II drugs for Upper Limb Muscle Spasticity does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RT-002 LoA Report.

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Pharmaceutical Technology

JUNE 10, 2023

RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. According to GlobalData, Phase II drugs for Hyperinsulinemia does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RZ-358 LoA Report.

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Pharmaceutical Technology

JUNE 10, 2023

Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. According to GlobalData, Phase I drugs for Pandemic Influenza does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report.

Vaccines 40

Vaccines Immunization Hospitals 40

Pharmaceutical Technology

JUNE 10, 2023

PB-357 is under clinical development by Puma Biotechnology and currently in Phase I for Breast Cancer. According to GlobalData, Phase I drugs for Breast Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how PB-357’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Compounding 40

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Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. According to GlobalData, Phase I drugs for Brain Tumor does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the CIGB-128 LoA Report.

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Pharmaceutical Technology

JUNE 10, 2023

TAS-117 is under clinical development by Taiho Pharmaceutical and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the TAS-117 LoA Report.

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Pharmaceutical Technology

JUNE 10, 2023

Pimitespib is under clinical development by Otsuka Pharmaceutical and currently in Phase I for Metastatic Lung Cancer. According to GlobalData, Phase I drugs for Metastatic Lung Cancer does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Pimitespib LoA Report.

Chemotherapy 40

Chemotherapy 40

Pharmaceutical Technology

JUNE 10, 2023

NuGel is under clinical development by Shaperon and currently in Phase I for Sepsis. According to GlobalData, Phase I drugs for Sepsis does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the NuGel LoA Report. Buy the report here.

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40

Pharmaceutical Technology

JUNE 10, 2023

RT-002 is under clinical development by Revance Therapeutics and currently in Phase II for Upper Limb Muscle Spasticity. According to GlobalData, Phase II drugs for Upper Limb Muscle Spasticity does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the RT-002 LoA Report.

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