STAT

FEBRUARY 26, 2023

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles.

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FDA 124

Med Ed 101

FEBRUARY 26, 2023

I’ve followed the NAPLEX exam since I graduated in 2009. The NAPLEX was relatively easy from my experience and the experience of many of my classmates. The pass rate that year was an indicator that the NAPLEX was not very difficult. That is not the case anymore. Just looking at the California Board of Pharmacy […] The post What The NAPLEX 2022 Pass Rate Tells Us About 2023 appeared first on Med Ed 101.

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Roots Analysis

FEBRUARY 26, 2023

Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long-acting drug delivery (LADD) of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases. LADD has emerged as the novel and advanced drug delivery system which manipulate the dosing regimen of the drug in the body in order to sustain its therapeutic level.

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Dosage 52

The Checkup by Singlecare

FEBRUARY 26, 2023

Causes of hand tremors | Types of hand tremors | Natural treatments | Other treatments | Is there a cure for hand tremor? | When to see a doctor Tremor is a neurological condition of involuntary muscle contractions that cause shaking movements in one or more body parts. It usually affects the hands, but can also affect the legs, head, vocal cords, and torso.

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Controlled Substances Labelling 52

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.

Fierce Healthcare

FEBRUARY 26, 2023

Homeward moves into rural Minnesota in partnership with Blue Cross plan hlandi Mon, 02/27/2023 - 00:24

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Pharmaceutical Technology

FEBRUARY 26, 2023

Dezapelisib is under clinical development by Incyte and currently in Phase I for Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase I drugs for Chronic Lymphocytic Leukemia (CLL) have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Dezapelisib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Specialty Pharmacies 40

Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Metastatic Colorectal Cancer. According to GlobalData, Phase I drugs for Metastatic Colorectal Cancer have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how CUE-102’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Immunization Pharmaceutical Companies Pharmaceutical Companies 40

Pharmaceutical Technology

FEBRUARY 26, 2023

Cellular Immunotherapy for Non-Small Cell Lung Cancer is under clinical development by Iovance Biotherapeutics and currently in Phase II for Non-Small Cell Lung Cancer. According to GlobalData, Phase II drugs for Non-Small Cell Lung Cancer have a 39% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Cellular Immunotherapy for Non-Small Cell Lung Cancer’s drug-specific PTSR and Likelihood of Approval (LoA) scores

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Immunization 40

Pharmaceutical Technology

FEBRUARY 26, 2023

Dezapelisib is under clinical development by Incyte and currently in Phase I for Hairy Cell Leukemia. According to GlobalData, Phase I drugs for Hairy Cell Leukemia have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Dezapelisib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Specialty Pharmacies 40

Specialty Pharmacies 40

Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Gastroesophageal (GE) Junction Carcinomas. According to GlobalData, Phase I drugs for Gastroesophageal (GE) Junction Carcinomas have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how CUE-102’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Immunization Pharmaceutical Companies Pharmaceutical Companies 40

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

FEBRUARY 26, 2023

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.

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FDA Immunization Chemotherapy 111

Pharmaceutical Technology

FEBRUARY 26, 2023

EDP-1815 is under clinical development by Evelo Biosciences and currently in Phase II for Plaque Psoriasis (Psoriasis Vulgaris). According to GlobalData, Phase II drugs for Plaque Psoriasis (Psoriasis Vulgaris) have a 47% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how EDP-1815’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Immunization 40