European Pharmaceutical Review

JANUARY 8, 2025

In the open-label portion of the CLEER-001 clinical trial of HT-001, 100 percent of cancer patients achieved the primary efficacy endpoint. Building evidence of efficiency in oncology In Sept 2024, the company announced promising evidence for HT-001 for a first-of-a-kind treatment. What did the gel formulation trial find?

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Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

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Hospitals Dosage Labelling 52

Pharmaceutical Business Review

OCTOBER 21, 2024

The positive opinion from CHMP is based on the results from the Phase III NATALEE trial, which is a global, multi-centre, open-label study. The safety profile of Kisqali at the 400mg dosage was also highlighted as well-tolerated, with most adverse events being of low grade. This also includes those with node-negative disease.

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RX Note

NOVEMBER 12, 2024

In November 2024, a new Micromedex app was introduced to deliver more efficient access to all Micromedex content, including Drug Reference, Drug Interactions, IV Compatibility and calculators. In my experience, there are increasingly more off-label uses and dosages included in this resource.

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Dosage Labelling 52

The Thyroid Pharmacist

NOVEMBER 29, 2023

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 95 expiring in March 2024.)

Health and Personal Care Stores 73

Health and Personal Care Stores Immunity Immunization Labelling 73

RX Note

AUGUST 25, 2024

A quick question: Do you know the common dosage of St. 2018 Understanding complementary medicines, 2024 Herbs at a Glance Medline Plus - Herb Memorial Sloan Kettering Cancer Center - Herb University of Rochester Medical Center - Herb John's Wort or its typical uses? In university, we often highlighted St.

Diabetes 52

Diabetes Community Pharmacies Dosage Documentation 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Recommendation, 2024 FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. Thirty-eight states currently authorize marijuana in different dosage formulations for specific qualifying medical conditions.

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

FDA Law Blog: Biosimilars

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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Drug Pricing Biosimilars Dosage Documentation 45

FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. § Basis at 63-64.

Controlled Substances 69

Controlled Substances Chemotherapy Dosage Labelling 69

Pharmaceutical Technology

JANUARY 6, 2023

At the centre of the case was Gilenya’s ‘405 patent, which details methods for treating relapsing multiple sclerosis with a specific dosage of the drug. In September, Novartis sent the FDA a petition, after a similar one was rejected in April 2021, asking for Entresto’s patent protection to be extended to February 2024.

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Documentation Hospitals Dosage Drug Pricing 97

Express Pharma

NOVEMBER 7, 2024

On 7 November 2024, the U.S. The committee reviewed new data regarding the oral administration of phenylephrine and unanimously concluded that the current scientific evidence does not support its effectiveness at the recommended OTC dosage. Theresa Michele, M.D.,

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Dosage Labelling 104

Express Pharma

DECEMBER 30, 2024

Efficacy and Safety The subcutaneous injection of nivolumab and hyaluronidase-nvhy was evaluated in CHECKMATE-67T (NCT04810078), a multicenter, randomised, open-label trial in patients with advanced or metastatic clear cell renal cell carcinoma who received no more than 2 prior systemic treatment regimens.

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Adverse Reactions Dosage Chemotherapy Labelling 52

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS next reviewed studies investigating safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and labeling of relevant FDA-approved products. Three Republican senators on the Foreign Relations Committee advised to consider U.S.

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Controlled Substances Chemotherapy Dosage Labelling 95