Pharmaceutical Technology

APRIL 6, 2023

The PRIME scheme designation was granted by the EMA based on positive results obtained from the ongoing Phase IIb randomised, open-label KEYNOTE-942/mRNA-4157-P201 trial that enrolled 157 patients with stage III/IV melanoma.

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Vaccines Labelling Immunity Immunization 98

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.

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Labelling Communication 83

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.

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Labelling Communication 59

Pharmaceutical Technology

MAY 10, 2023

In January 2023, CytoMed gained clearance from Singapore’s health science authority to carry out a first-in-human Phase I single-site, open-label, dose-escalating trial of its CTM-N2D allogeneic chimeric antigen receptor T-cell (CAR-T) candidate for blood and solid tumour cancers.

Labelling 59

Labelling 59

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.

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Labelling Communication 98

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.

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Labelling Packaging Documentation Dosage 52

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.

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Labelling Patient Counseling Communication 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.

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Labelling Diabetes Communication Pharmaceutical Companies 145

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.

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Labelling Bioethics Pharmaceutical Companies Pharmaceutical Companies 144

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. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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Labelling Communication 105

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. In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201. Tenaya is also running two supplementary non-interventional studies for the drug.

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Mayo Clinic Labelling Communication 97

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.

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Chemotherapy 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.

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Labelling Packaging Diabetes Communication 52

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. Researchers observed an 89% and 79% reduction in new gadolinium-enhancing (GdE) T1-lesions for higher and lower doses, respectively, compared to placebo.

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Labelling Communication Immunity Immunization 64

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. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

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Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

MAY 30, 2023

The data is exploratory and the company has not yet announced any plans to expand Orsedu’s label. But that these results demonstrate the potential clinical benefits and warrant further study, she added.

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Labelling Communication 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. The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time.

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Labelling Communication Drug Development 59

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. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

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Insurance Coverage and Processing Diabetes Labelling Communication 98

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.

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Immunity Immunization Labelling Communication 52

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. It specifically seeks to improve the Medicaid Drug Rebate Program (MDRP). The proposal also includes steps to make the MDRP more efficient.

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Drug Pricing Vaccines Labelling Communication 52

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. By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy.

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Biosimilars Labelling Communication Hospitals 104

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. By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy.

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Drug Pricing 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. FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older.

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Packaging Vaccines Labelling Diabetes 59

Pharmaceutical Technology

APRIL 26, 2023

The list also contains companies providing regulatory services, validations, package design verification testing, quality and microbial testing as well as different products, such as sterile barrier pouches and rigid trays for sterile implants, blister packages, strip packages, vials, ampoules, caps, bottles, desiccants and more.

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Packaging Documentation Communication Labelling 52

Pharmaceutical Technology

APRIL 24, 2023

Since then, the drug has been used off-label in breast cancer and other types of cancer. With early nanoparticle studies, researchers often found the human body’s innate immune response to drugs and the short-lasting effects of drugs challenging, as they can also reduce a drug’s efficacy.

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Vaccines Immunity Immunization Medical Schools 59

Pharmaceutical Technology

JANUARY 6, 2023

Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. By clicking the Download Free Report button, you accept the terms and conditions and acknowledge that your data will be used as described in the GlobalData privacy policy.

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Documentation Hospitals Dosage Drug Pricing 97

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.

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Communication Diabetes Labelling 52

Pharmaceutical Technology

DECEMBER 22, 2022

At last month’s WODC-EU, a policy advisor for the German Ministry of Health was of this opinion. 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.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

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). as the secondary endpoints.

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Chemotherapy Labelling Communication Pharmaceutical Companies 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). It plans to work with the FDA to plan new analyses and further develop a new application package.

Packaging 52

Packaging Labelling Communication 52

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. Keytruda for the trial is provided by MSD (Merck & Co). The Phase I is divided into two parts.

Labelling 52

Labelling Communication Vaccines 52

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. The demand for Wegovy has been rising in recent times, with several reports on the drug’s shortages.

Packaging 52

Packaging Chemotherapy Labelling Communication 52