Chemotherapy, Communication and FDA - Pharmacy Technician Pulse

FDA pulls approval of COVID-19 antibody treatment due to inefficacy against variants

Pharmafile

JANUARY 27, 2023

The FDA has revoked its approval of AstraZeneca’s Evusheld due to the fact that it is not effective against more than 90% of COVID-19 variants currently in circulation in the US. read more

FDA

FDA Chemotherapy Immunization Communication

Fennec’s hearing loss drug for cancer patients wins breakthrough FDA nod

Pharmaceutical Technology

SEPTEMBER 23, 2022

The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. The current standard of care for many cancers is cisplatin chemotherapy or platinum therapy.

FDA

FDA Communication Chemotherapy Labelling

International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

JULY 4, 2023

Since the first ADC was approved by the EMA in 2012, they have generated a great deal of interest in the oncology field because of their potential to address many of the challenges of traditional chemotherapy options. Teams must also accept the variety of analytical procedures these regulatory agencies prefer.

Communication

Communication Dosage Chemotherapy Documentation

Cymbalta generic availability, cost, and dosage

The Checkup by Singlecare

OCTOBER 16, 2023

Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. Cymbalta may have several off-label uses in addition to its FDA-approved uses. It is also approved for fibromyalgia and chronic muscle pain. Approved by the U.S.

Dosage

Dosage Insurance Coverage Labelling Insurance

What causes sharp pain on the right side of the body?

The Checkup by Singlecare

NOVEMBER 13, 2023

According to the CDC , treatment includes surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these treatments. To help decrease the risk of shingles, Shingrix vaccine is FDA-approved for adults 50 and older. Like pulmonary hypertension, asthma cannot be cured, but it can be managed by using inhalers.

Mayo Clinic

Mayo Clinic Vaccines Chemotherapy Communication

Amoxicillin-potassium clavulanate interactions to avoid

The Checkup by Singlecare

OCTOBER 27, 2023

How to minimize amoxicillin-potassium clavulanate interactions Your best bet to avoid drug-drug interactions involving amoxicillin-potassium clavulanate is to communicate well with your medical providers.

Adverse Reactions

Adverse Reactions Labelling Chemotherapy Communication

Ondansetron interactions to avoid

The Checkup by Singlecare

JANUARY 12, 2024

Therefore, any onset of symptoms should be managed by immediate communication with a healthcare professional. Communicate directly with a healthcare professional anytime you require ondansetron so that a comprehensive review of interactions of both medications, diet, and conditions can occur to ensure a proper monitoring plan is put in place.

Mayo Clinic

Mayo Clinic Communication Dosage Chemotherapy

SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

ISPE

MAY 10, 2023

Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” You may unsubscribe from these ISPE communications at any time. SPuMoNI is particularly timely because blockchain has been proposed to become “a new digital service infrastructure” for Europe. 30 June 2016. link] 6 BBC News. Published 19 January 2017. Cai, and X.

Dosage

Dosage Chemotherapy Documentation Labelling

FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

Dosage

Dosage FDA Pharmaceutical Companies Pharmaceutical Companies

FDA gives Ferring go-ahead for Adstiladrin gene therapy manufacturing

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). Non-muscle invasive bladder cancer is characterised by cancer cells that remain only in the lining of the bladder.

FDA

FDA Vaccines Chemotherapy Communication

MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker

Pharmaceutical Technology

JUNE 16, 2023

In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum.

Chemotherapy

Chemotherapy Labelling FDA Communication

SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval. Please check your email to download the Report.

Chemotherapy

Chemotherapy FDA Communication Immunization

FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. Promising results were observed, with outcomes of 19.0% ORR, 81.0%

FDA

FDA Chemotherapy Labelling Pharmaceutical Companies

CMO Moves: Regulatory catalysts for drug manufacturing- February

Pharmaceutical Technology

FEBRUARY 27, 2023

The ADC is already approved in the metastatic setting after chemotherapy or in the case of disease recurrence during or in six months after adjuvant chemotherapy. Regulatory decisions by the US FDA for select therapies from late December to late January, and the CMOs contracted to manufacture them.

Packaging

Packaging Chemotherapy FDA Labelling

AlgoTx unveils plans for Phase II trial for rare chronic condition

Pharmaceutical Technology

MARCH 29, 2023

In June 2020, the FDA gave ATX01 an orphan drug designation in erythromelalgia. Stéphane Thiroloix, CEO of AlgoTx Alongside erythromelalgia, the company is testing ATX01 in a Phase II study in chemotherapy-induced peripheral neuropathy (CIPN). Please check your email to download the Report.

Chemotherapy

Chemotherapy Compounding Communication FDA

Pharmacy Technician Pulse

FDA pulls approval of COVID-19 antibody treatment due to inefficacy against variants

Fennec’s hearing loss drug for cancer patients wins breakthrough FDA nod

Trending Sources

International regulation: the importance of quality assurance in drug development

Cymbalta generic availability, cost, and dosage

What causes sharp pain on the right side of the body?

Amoxicillin-potassium clavulanate interactions to avoid

Ondansetron interactions to avoid

SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies

FDA drug dosage optimisation guidelines signal clinical trial reform

FDA gives Ferring go-ahead for Adstiladrin gene therapy manufacturing

MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker

SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial

FDA approves Biostar’s Phase II/III plans with utidelone injectable for NSCLC

CMO Moves: Regulatory catalysts for drug manufacturing- February

AlgoTx unveils plans for Phase II trial for rare chronic condition

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