Pharmaceutical Technology

MAY 3, 2023

With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

Mayo Clinic 97

Mayo Clinic FDA Labelling Communication 97

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. By GlobalData. United Kingdom.

Labelling 104

Labelling Communication Hospitals FDA 104

Pharmaceutical Technology

JANUARY 6, 2023

Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector. By GlobalData. United Kingdom.

Documentation 97

Documentation FDA Hospitals Dosage 97

Pharmaceutical Technology

FEBRUARY 21, 2023

Its decision is based on the data obtained from the ongoing, open-label, multinational, single-arm, pivotal Phase III HOPE-B trial. The regulatory approval followed a positive opinion from Committee for Medicinal Products for Human Use (CHMP) in December last year. The trial is designed to evaluate the safety and efficacy of Hemgenix.

Labelling 52

Labelling Communication 52

Pharmaceutical Technology

FEBRUARY 17, 2023

The data from our recently announced 18-month HOPE-2 open-label extension study showed evidence of disease modification and showed statistically significant differences in the Performance of the Upper Limb (PUL).” “CAP-1002 has shown clinical benefits for cardiac and skeletal muscle myopathy, which few therapies have demonstrated.

Labelling 52

Labelling Communication 52

Pharmaceutical Technology

JANUARY 15, 2023

In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children. The EMA also expanded the label of AbbVie’s Skyrizi (risankizumab) to include its use to treat moderate-to-severe Crohn’s disease.

Labelling 52

Labelling Packaging FDA Communication 52

Pharma Marketing Network

FEBRUARY 19, 2025

Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. Drug names and indications must align with FDA-approved labeling. signing up for a webinar, downloading a whitepaper)? Click-Through Rate (CTR) : Are recipients engaging with links?

HIPAA 72

HIPAA FDA Labelling Communication 72

Pharmaceutical Technology

JUNE 1, 2023

After this, patients receiving a placebo were switched to the frexalimab arm and entered the ongoing open-label part B portion of the study. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

Labelling 64

Labelling Communication Immunization 64

Pharmaceutical Technology

JUNE 16, 2023

Designated as BG01-2202, this latest trial will be an open-label, randomised, controlled clinical study of UTD1 versus chemotherapy drug docetaxel. This latest study approval follows a previous open-label, multi-centre Phase II trial conducted in China (NCT03693547). Please check your email to download the Report.

FDA 52

FDA Chemotherapy Labelling Pharmaceutical Companies 52

Pharmaceutical Technology

JUNE 16, 2023

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. Please check your email to download the Report.

Chemotherapy 52

Chemotherapy Labelling FDA Communication 52

Pharmaceutical Technology

APRIL 26, 2023

Companies are continuously evolving to develop more intelligent and interactive packaging for pharmaceuticals and medical devices, which can effectively communicate between providers and consumers by tracking the package, recording the dosing activity, and proving the prescription information of a patient.

Packaging 52

Packaging Documentation Communication Labelling 52

Pharmaceutical Technology

MAY 30, 2023

The data is exploratory and the company has not yet announced any plans to expand Orsedu’s label. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

Labelling 59

Labelling Communication FDA 59

Pharmaceutical Technology

MAY 23, 2023

In its Q1 report , Centessa stated plans to present more data from part five of the open-label expansion of the Phase IIa study, subject to completion, at an undisclosed scientific meeting in 2023. Download the full report to understand what to expect and how to align your strategies for success.

FDA 59

FDA Labelling Communication 59

Pharmaceutical Technology

MARCH 20, 2023

Providing research companies with centralised distribution and procurement and the added value to rapidly move clinical trial material, manage biospecimen transportation, perform re-labelling and so on, will most definitely contribute positively to clinical supply chain outcomes,” comments van den Bergh.

Communication 52

Communication Labelling 52

Pharmaceutical Technology

JUNE 20, 2023

Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164). Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

FDA 52

FDA Packaging Labelling Communication 52

Pharmaceutical Technology

MAY 11, 2023

The company’s expertise in the areas of radiochemistry and labelling technology will also help UCB to study how this technology could lead to the discovery of differentiated products for immune-related diseases. Please check your email to download the Whitepaper.

Immunization 52

Immunization Labelling Communication 52

Pharmaceutical Technology

DECEMBER 22, 2022

However, he did point out that the joint assessment could be a useful way of narrowing down typically broad EMA label content to specific patient populations. Please check your email to download the Case Study. A German expert in healthcare strategy and market access with over 35 years in the pharma industry agreed. United Kingdom.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report. Evaluate the effects of COVID-19 on the sector.

Vaccines 59

Vaccines Immunization Medical Schools FDA 59

Pharmaceutical Technology

MARCH 6, 2023

Based on preclinical research for their impact on aging, well-known drugs like metformin and rapamycin are already being considered for off-label usage, due to their accepted safety profile and cost-effectiveness. Bellantuono worries that labeling aging as a disease indication could be “agist” and would have social implications.

FDA 145

FDA Labelling Pharmaceutical Companies Pharmaceutical Companies 145

Pharmaceutical Technology

MAY 12, 2023

According to the FDA update, current labels for these drugs do not have up-to-date warnings about the risks of drug misuse and abuse and fail to mention that most individuals who misuse prescription stimulants source drugs from other family members or peers. Please check your email to download the Report.

Labelling 59

Labelling FDA Communication 59

Pharmaceutical Technology

MAY 25, 2023

The ongoing Phase 1/2a ( NCT04725331 ) study is a multicentre, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with the anti-PD-1 treatment, Keytruda. Download the full report to understand what to expect and how to align your strategies for success. The Phase I is divided into two parts.

Labelling 52

Labelling Communication Vaccines 52

Pharmaceutical Technology

JANUARY 5, 2023

The pharmaceutical industry has long been labelled as a recession-proof—stable demand for medicines and new treatment options acts as a protective barrier. Download our latest executive summary for a snapshot view of what our clients use to formulate winning strategies. Please check your email to download the Report.

Vaccines 69

Vaccines Labelling Communication 69

Pharmaceutical Technology

MARCH 21, 2023

A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

Packaging 59

Packaging FDA Vaccines Labelling 59

Pharmaceutical Technology

FEBRUARY 27, 2023

FDA decisions In December 2022, the FDA expanded the label for Novo Nordisk’s Wegovy (semaglutide), to include its use as an anti-obesity drug in adolescents with an initial body mass index over a certain threshold. Download the full report to understand what to expect and how to align your strategies for success.

Packaging 52

Packaging Chemotherapy FDA Labelling 52

The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” thingsIlearnedthehardway). May improve immune function : B. You are worth it!

Health and Personal Care Stores 105

Health and Personal Care Stores Immunization Grocery Stores Compounding 105

Pharmaceutical Technology

MARCH 16, 2023

Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz.

Labelling 144

Labelling Pharmaceutical Companies Pharmaceutical Companies Communication 144

The Thyroid Pharmacist

OCTOBER 27, 2023

These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Precautions Do not take more than the recommended dose on the label. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria.

Health and Personal Care Stores 104

Health and Personal Care Stores Immunization Compounding Packaging 104

The Thyroid Pharmacist

OCTOBER 6, 2023

Check food labels carefully, and be extra careful if you are eating out, as it’s difficult to know all of the ingredients used in restaurants. P.S. You can download a free Thyroid Diet Guide, 10 thyroid-friendly recipes, and the Nutrient Depletions and Digestion chapter of my first book for free by signing up for my newsletter.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunization Dosage Compounding 98

Pharmaceutical Technology

MAY 24, 2023

This includes giving CMS the power to suspend the National Drug Rebate Agreement of a labeller for less than 30 days in case of late reporting of required drug and price information. Download the full report to understand what to expect and how to align your strategies for success. Please check your email to download the Report.

Vaccines 52

Vaccines Labelling Communication 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. To date, vaginally-applied DHEA is still only available through prescription, either as Intrarosa® or an off-label customized prescription.

Documentation 98

Documentation Dosage FDA Labelling 98