pharmaphorum

AUGUST 11, 2021

A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast cancer in England and Wales.

Chemotherapy 64

Chemotherapy Documentation Hospitals 64

pharmaphorum

FEBRUARY 8, 2022

In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US.

FDA 52

FDA Documentation Chemotherapy 52

pharmaphorum

OCTOBER 11, 2022

The Scottish Medicines Consortium (SMC) gave the go-ahead to the regimen based on data from the KEYNOTE-775 study , which showed that the duo can increase survival time for patients and may improve quality of life by reducing the symptom burden compared to standard chemotherapy.

Chemotherapy 52

Chemotherapy Documentation 52

NICE

APRIL 3, 2023

Contributing my personal experience to the discussion, I shared my experience of developing chronic peripheral neuropathy, which came about as a side effect following chemotherapy. about managing and monitoring symptoms and reducing dosage of chemotherapy if necessary will also help.

Dosage 52

Dosage Chemotherapy Documentation 52

pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

FDA 69

FDA Chemotherapy Documentation 69

pharmaphorum

MARCH 8, 2022

In the study, Trodelvy (sacituzumab govitecan) met its objective of reducing progression-free survival in patients with HR-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment – including endocrine drugs, CDK4/6 inhibitors and two to four lines of chemotherapy.

Chemotherapy 52

Chemotherapy Documentation Labelling 52

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.

Communication 86

Communication Dosage Chemotherapy Documentation 86

pharmaphorum

MARCH 18, 2021

AstraZeneca’s BTK inhibitor Calquence has become the first targeted oral therapy to be backed by NICE for NHS England patients with chronic lymphocytic leukaemia (CLL) who can’t be treated with first-line chemotherapy. The decision is at odds with the situation in Scotland, where Nilemdo was turned down in December.

Hospitals 52

Hospitals Chemotherapy Documentation FDA 52

Druggist

APRIL 29, 2021

Patients who have cancer or receive chemotherapy. More details can be found in a document called Guidance for the safe switching of warfarin to direct oral anticoagulants (DOACs) for patients with non-valvular AF and venous thromboembolism (DVT / PE). Patients with severe renal (kidney) impairment.

Dosage 98

Dosage Chemotherapy Documentation Compounding 98

Pharmaceutical Technology

NOVEMBER 4, 2022

Marian McNeil says she became interested in precision medicine when working for a company developing oral cancer treatments that would avoid the need for intravenous chemotherapy. To learn more about how digital health is transforming health services in Scotland, download the document on this page. It's an exciting place to be.”.

Chemotherapy 52

Chemotherapy Documentation 52

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 1942 – Chemotherapy moves from trenches to treatment . Before the birth of bone marrow transplants, patients were often treated using chemotherapy, which could be used to kill cancer cells.

Chemotherapy 93

Chemotherapy Immunization FDA Documentation 93

Pharmaceutical Technology

MARCH 30, 2023

On March 27, MSD announced that the combined use of Keytruda with chemotherapy significantly improved progression-free survival versus the chemotherapy alone, as a first-line therapy for advanced or recurrent endometrial carcinoma. This announcement is not the only recent development for Keytruda.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

ISPE

NOVEMBER 1, 2022

International convergence is another area in which the FDA is a participant, including in initiatives related to viral safety (ICH Q5A), CM (ICH Q13), quality risk management (QRM; ICH Q9), analytical procedure development (APD; ICH Q2/14), pharmaceutical product life-cycle management (ICH Q12), and common technical document (ICH M4Q).

FDA 98

FDA Insurance Chemotherapy Documentation 98

Pharmaceutical Technology

SEPTEMBER 20, 2022

In a final appraisal document (FAD), the institute recommended the treatment for use in adult patients who have received a minimum of one therapy, only if bendamustine plus rituximab is also appropriate. The post BeiGene gets NICE recommendation for Waldenström’s Macroglobulinemia therapy appeared first on Pharmaceutical Technology.

Chemotherapy 52

Chemotherapy Documentation 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. Mexican Governor: Cancer Children Given Water Instead of Chemotherapy.” 30 June 2016.

Dosage 52

Dosage Chemotherapy Documentation Labelling 52