Communication, Download and Labelling

US FDA clears Transcenta’s IND for Rett syndrome treatment

Pharmaceutical Technology

JANUARY 24, 2023

The multi-centre, open-label, single-arm clinical trial has been designed to evaluate the efficacy, tolerability, and safety of a single dose of NGN-401 delivered using a one-time ICV procedure. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

Labelling

Labelling Communication

5 Qualities to Look for in Your Veterinary Pharmacy Partners

epicur

FEBRUARY 23, 2023

Accurate Ingredient Labeling Accurate labeling also applies more in 503A pharmacies than 503B outsourcing facilities due to stricter regulations on 503B manufacturers. 503A pharmacies have less testing, or sometimes no testing, to verify their label claims. Our blog gives you a comprehensive look at the two. Read the Blog 3.

Compounding Pharmacies

Compounding Pharmacies Compounding Labelling Dosage

Paw-sitively Efficient Inventory Management for Veterinary Professionals

epicur

DECEMBER 7, 2023

Download: Seasonal Prep Checklist for Veterinary Practices (It makes a great print-out for your practice!) Download our inventory management guide for 7 best practices that increase ROI. Clearly label shelves and containers to minimize confusion. Haven’t made the switch to digital tools in your practice?

Inventory Audits

Inventory Audits Labelling Hospitals Compounding

Webinars

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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China NMPA accepts Juventas’ NDA for leukaemia treatment

Pharmaceutical Technology

DECEMBER 16, 2022

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy.

Labelling

Labelling Communication

CSL receives EC CMA approval for haemophilia B gene therapy

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

Labelling Communication

Capricor and Nippon Shinyaku partner for DMD therapy distribution in Japan

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

Labelling Communication

Health Canada expands Orkambi label to include access to infants

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

Labelling

Labelling Communication

The Best Probiotics for Hashimoto’s

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

Health and Personal Care Stores Immunity Immunization Grocery Stores

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Human Touch - Why Artificial Intelligence cannot replace us still? Theory in Practice - Life is not ideal but a struggle Life - Why?

HIV Treatment and Prevention Agents

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy

What to Keep in Your Integrative Medicine Cabinet

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

Health and Personal Care Stores Immunity Immunization Compounding

Overcoming regulatory issues with investigational medicinal product labelling

Pharmaceutical Technology

JUNE 19, 2023

Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.

Labelling

Labelling Packaging Documentation Dosage

Histamine and Hashimoto’s

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

Health and Personal Care Stores Immunity Immunization Dosage

FDA updates stimulant labelling requirements to reduce misuse

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

Labelling Patient Counseling Communication

Dawn of a new indication: how to study drugs for aging

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.

Labelling

Labelling Communication Diabetes Pharmaceutical Companies

Africa: Unleashing the potential of the new superpower in clinical trials

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

Communication Diabetes Labelling

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. Download the full report to understand what to expect and how to align your strategies for success.

Insurance Coverage and Processing

Insurance Coverage and Processing Diabetes Labelling Communication

CMO Moves: Regulatory catalysts for therapy manufacturing -January

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

Labelling Packaging Communication Diabetes

The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. Download the full report to understand what to expect and how to align your strategies for success.

Insurance Coverage and Processing

Insurance Coverage and Processing Diabetes Labelling Communication

AstraZeneca ends Phase IV Andexxa trial after positive results

Pharmaceutical Technology

JUNE 7, 2023

AstraZeneca will now proceed with regulatory filings in the US and EU to convert to full label approval, with full results from the trial to be presented at a forthcoming medical meeting. Download the full report to understand what to expect and how to align your strategies for success. Evaluate the effects of COVID-19 on the sector.

Labelling

Labelling Communication

Development and Manufacturing of Primary Packaging and Medical Devices

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

Packaging Documentation Communication Labelling

Tenaya’s cardiomyopathy gene therapy gets fast track boost

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

Mayo Clinic Labelling Communication

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

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.

Chemotherapy

Chemotherapy Labelling Communication Pharmaceutical Companies

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

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

Chemotherapy Labelling Communication

Humira biosimilars set the stage for long-awaited 2023 US launches

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.

Exforge antitrust settlement caps Novartis’ year of legal disputes

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

Documentation Hospitals Dosage Drug Pricing

Inflation, drug pricing and reimbursement constraints will challenge pharma sector

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.

Drug Pricing

Drug Pricing Vaccines Labelling Communication

CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

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

Packaging Vaccines Labelling Communication

Sanofi’s frexalimab shows early potential in in Phase II multiple sclerosis trial

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

Labelling Communication Immunity Immunization

Early signals suggest oral SERD’s potential for more breast cancer patients

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

Labelling Communication

Centessa’s haemophilia therapy wins FDA fast track designation

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.

Labelling

Labelling Communication Drug Development

F2G plans resubmission after FDA rejects Olorofim NDA

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.

Packaging

Packaging Labelling Communication

Transgene and BioInvent report positive data for oncolytic virus

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

Labelling Communication Vaccines

US government plans proposal to push down Medicaid drug prices

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.

Drug Pricing

Drug Pricing Vaccines Labelling Communication

Covid-19 vaccine success bolsters nanoparticle drug delivery research

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

Vaccines Immunity Immunization Medical Schools

The EU joint HTA procedure: a gate or barrier for access?

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

Pharmaceutical Companies Pharmaceutical Companies Labelling Communication

Ariceum and UCB to seek therapies for immune-related diseases and cancer

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

Immunization Immunity Labelling Communication

Solutions to Increase Low Libido in Those with Hashimoto’s

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.

Dosage

Dosage Documentation Diabetes Labelling

Legal challenges put off label use of gender affirming care drugs in jeopardy

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

Labelling Bioethics Pharmaceutical Companies Pharmaceutical Companies

CMO Moves: Regulatory catalysts for drug manufacturing- February

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

Packaging Chemotherapy Labelling Communication

US FDA clears Transcenta’s IND for Rett syndrome treatment

5 Qualities to Look for in Your Veterinary Pharmacy Partners

Webinars

Trending Sources

Paw-sitively Efficient Inventory Management for Veterinary Professionals

Webinars

China NMPA accepts Juventas’ NDA for leukaemia treatment

CSL receives EC CMA approval for haemophilia B gene therapy

Capricor and Nippon Shinyaku partner for DMD therapy distribution in Japan

Health Canada expands Orkambi label to include access to infants

The Best Probiotics for Hashimoto’s

Contents

What to Keep in Your Integrative Medicine Cabinet

Overcoming regulatory issues with investigational medicinal product labelling

Histamine and Hashimoto’s

FDA updates stimulant labelling requirements to reduce misuse

Dawn of a new indication: how to study drugs for aging

Africa: Unleashing the potential of the new superpower in clinical trials

The “Medical Bypass”: new drugs to strike obesity

CMO Moves: Regulatory catalysts for therapy manufacturing -January

The “Medical Bypass”: new drugs to strike obesity

AstraZeneca ends Phase IV Andexxa trial after positive results

Development and Manufacturing of Primary Packaging and Medical Devices

Tenaya’s cardiomyopathy gene therapy gets fast track boost

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

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

Humira biosimilars set the stage for long-awaited 2023 US launches

Exforge antitrust settlement caps Novartis’ year of legal disputes

Inflation, drug pricing and reimbursement constraints will challenge pharma sector

CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Sanofi’s frexalimab shows early potential in in Phase II multiple sclerosis trial

Early signals suggest oral SERD’s potential for more breast cancer patients

Centessa’s haemophilia therapy wins FDA fast track designation

F2G plans resubmission after FDA rejects Olorofim NDA

Transgene and BioInvent report positive data for oncolytic virus

US government plans proposal to push down Medicaid drug prices

Covid-19 vaccine success bolsters nanoparticle drug delivery research

The EU joint HTA procedure: a gate or barrier for access?

Ariceum and UCB to seek therapies for immune-related diseases and cancer

Solutions to Increase Low Libido in Those with Hashimoto’s

Legal challenges put off label use of gender affirming care drugs in jeopardy

CMO Moves: Regulatory catalysts for drug manufacturing- February

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