Pharmacy Times

JULY 9, 2025

As evidence evolves, pharmacists can lead in translating research into practice—implementing screening, personalized dosing, and interprofessional coordination while awaiting definitive trial results. 1-4 REFERENCES 1. Jiang Y, Dang W, Sui L, et al. Associations Between Vitamin D and Core Symptoms in ASD: An umbrella review. 2024;16:59–91.

Pharmacy Technician 40

Pharmacy Technician Compounding Pharmacies Pharmacy Management Immunization 40

Pharmacy Times

JUNE 12, 2025

1,2 The primary end point was event-free survival (EFS), which was defined as the time from randomization to the first occurrence of disease progression precluding definitive surgery, local or distant disease progression or recurrence, or death due to any cause. The key secondary end point was overall survival (OS). months (95% CI: 37.9,

Pharmacy Technician 32

Pharmacy Technician Compounding Pharmacies Pharmacy Management Immunization 32

Pharmacy Times

JUNE 6, 2025

Klein: In terms of the management of pericarditis and recurrent pericarditis, let me just go through definitions. Are there specific comorbidities or patient characteristics that influence your decision? Acute pericarditis is the inflammation of the lining of the heart.

Pharmacy Technician 26

Pharmacy Technician Specialty Pharmacies Diabetes Compounding Pharmacies 26

European Pharmaceutical Review

FEBRUARY 23, 2023

There is no definitive answer as to whether life sciences companies should, or should not, opt their EPs out of the UPC. On the contrary, keeping stronger patents, eg, compound patents, in and opting less robust, second‑medical‑use patents out may help favourably shape the jurisprudence.

Biosimilars 98

Biosimilars Compounding 98

European Pharmaceutical Review

JULY 4, 2024

It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product. The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards.

Drug Development 103

Drug Development Documentation Labelling Biosimilars 103

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. Non-applicable drugs (e.g.,

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

Pharma in Brief

JANUARY 25, 2023

Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ). Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use.

Biosimilars 52

Biosimilars Dosage Labelling Compounding 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

within the CSA’s definition of “marihuana” or “marijuana” based on FDA’s eight factor analysis. whether growing or not; its seeds; resin extracted from any part; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin. 21 U.S.C. § 802(16)(A). 21 U.S.C. § 802(16)(B).

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

PharmaShots

APRIL 3, 2023

The P-III trial (GUARD) results showed no safety signals & were found to be well tolerated with no observed treatment-emergent serious AEs ADX-2191 is a sterile, non-compounded IVT formulation of methotrexate for specific rare retinal diseases. The authorization incl. It also has a pipeline of drugs under development that incl.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

RX Note

FEBRUARY 23, 2023

. - Drug registration number Medicines (Advertisement & Sale) Act 1956 and Regulations - To learn prohibitions of medicine advertisement and Medicine Advertisement Board Registration of Pharmacists Act 1951 and Regulations - Pharmacy Board Malaysia and legislation aspects of provisional, full and temporary registration Code of Ethics for Pharmacists (..)

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JUNE 23, 2024

1] Under the relevant definitions in the CSA, the dispensing/delivery of controlled substances is limited to the “ultimate user” ( i.e., the patient or a member of the patient’s household). [2] 1] 21 U.S.C. § 802 (27) (The CSA’s “ultimate user” definition). [2] 2] Why is this an issue? 2] See, e.g. , id. § 3] 21 U.S.C.

Controlled Substances 98

Controlled Substances Compounding 98