Rethinking Clinical Trials

FEBRUARY 28, 2024

But there are concerns to developing DCTs including lack of standardization and validation, regulatory and ethical uncertainties, engagement vs. coercion, data security and privacy issues, technological literacy and access, resistance to change and adoption, and lack of “safe” sharing. from 2021 to 2026.

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Rethinking Clinical Trials

MAY 10, 2023

deliver one of the largest, richest biomedical datasets that is broadly available and secure; and catalyze an ecosystem of communities, researchers, and funders who make All of Us an indispensable part of research. The program will nurture partnerships for decades with at least a million participants who reflect the diversity of the U.S.;

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Medicine Research Clinical Trials Clinical Trials 130

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

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Production Pharma Production Pharma Companies Drugs 264

The Pharma Data

OCTOBER 29, 2021

Merck has tagged to withdraw its Premerger Notification and Report Form, which was originally filed on October 14, 2021, to give the Federal Trade Commission (the “ FTC”) with fresh time for review, and expects to refile similar form on or about November 1, 2021. Securities and Exchange Commission (the “ SEC”). Source link: [link].

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Containment Regulation Vaccination Vaccine 52

Rethinking Clinical Trials

AUGUST 30, 2023

There were also challenges with many software and security updates that impacted to the dashboard. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS) appeared first on Rethinking Clinical Trials.

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Trials Clinical Research Coordinator Medicine Clinical Trials 141

Rethinking Clinical Trials

NOVEMBER 21, 2023

Messages included PHI but the study followed the institutional security protocols that allowed the intervention to be approved. – How did the messages account for prescription dosage changes? Patients could reply with Done and the message reminders would stop. The study would then recalculate the gaps.

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Clinical Trials Clinical Trials Trials Development 141

Rethinking Clinical Trials

DECEMBER 12, 2023

The Jumpstart Guide was delivered to members of the primary hospital team on day of randomization via a secure email with a reminder message via pager. The primary outcome was the proportion of patients with EHR-documented goals of care discussion within 30 days of randomization. Clinicians could receive prompts on an almost daily basis.

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Trials Medicine Clinical Trials Clinical Trials 130

Cloudbyz

JUNE 1, 2023

Granular Security & Access Control Salesforce provides robust security and access control features, designed to help organizations secure their data while still providing necessary access to users. Field Level Security (FLS): FLS allows administrators to control user access to view and edit specific fields.

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Compliance Development Branding Production 82

XTalks

AUGUST 19, 2022

Zynteglo’s hefty price tag of $2.8 Zynteglo’s weighty price tag posed to be an issue in Europe, with bluebird having to pull the drug shortly after it was approved in the EU due to both issues with securing reimbursement payment plans, and manufacturing problems.

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Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

NOVEMBER 3, 2022

The company is currently conducting a study to demonstrate Mounjaro’s weight loss effects and secured an FDA Fast Track tag in the obesity indication. Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy. Lilly plans to begin a rolling submission for Mounjaro in the obesity indication in 2022.

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Sales FDA Approval Production Insulin 98

pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

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Sales Medicine Drugs Marketing 109

XTalks

JUNE 28, 2023

The therapy’s strong clinical safety data helped Sarepta secure the approval, as among 85 patients, only 13 serious side effects and no deaths or discontinuations due to adverse events were reported. million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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Gene Therapy Gene Protein FDA Approval 98

XTalks

APRIL 18, 2024

Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4). However, the guidance doesn’t say whether it could serve as a study’s primary endpoint on its own.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

pharmaphorum

NOVEMBER 27, 2022

Fully integrated and automated ingredient to consumer batch tracking using barcoding, RFID tagging, or IoT temperature logging and timestamping significantly reduces the chance of these mix-ups, providing complete traceability records from ingredient manufacturer to patient, and ensures the safety of the product.

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Production Manufacturing Drugs Marketing 101

Intouch Solutions

APRIL 11, 2024

Instead, it will be a transformational process that affects various functions of the organization, triggering considerations related to data privacy and security, regulatory compliance, and change management. First, it’s worth noting that this will not be a small change. How is AI being used in precision engagement?

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Compliance Marketing Drugs Pharma Companies 52

XTalks

OCTOBER 28, 2021

The release of the cake mix comes just weeks after Perfect Day secured another $350 million from a Series D funding round led by the Canada Pension Plan Investment Board and Temasek Holdings. Brave Robot debuted in 2020 with the launch of its ice cream and has since sold more than one million pints.

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Protein Packaging Packaging DNA 98

XTalks

NOVEMBER 24, 2022

CSL Behring is set to market the drug after having secured global commercialization rights from uniQure for $450 million in 2020. The Hemgenix approval was granted to CSL Behring , a rare disease biotech company based in Pennsylvania, which developed Hemgenix jointly with gene therapy biotech uniQure.

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Gene Therapy Gene FDA Approval Genetics 52

Rethinking Clinical Trials

SEPTEMBER 22, 2022

Denmark also has a mandatory electronic mailbox (e-BOKs) system that is required for all Danish citizens older than 18 and is linked to each citizen’s social security number. Denmark also has registries tracking socioeconomic data such as income and level of education and other types of data that can be linked together for study. Learn more.

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The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

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Vaccination Vaccine Trials Protein 52

pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . billion and $1.1

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Drugs FDA Approval Marketing Clinical Trials 52

XTalks

AUGUST 25, 2021

But without food sampling, consumers may not be able to justify the $6 price tag, let alone be aware of the brand. . While the bars were not given out to patients, they were given to most hospital workers, from security to nurses, to doctors and administrative staff.

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pharmaphorum

JANUARY 21, 2022

This evolution is leading to additional health benefits and health gains, but they are accompanied by major concerns, as very high price tags raise questions about their affordability.”. In recent years, revolutionary medicines have come with price tags to match, but this is simply a symptom of our current model.

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Medicine Marketing Manufacturing Production 52

XTalks

APRIL 29, 2022

Wegovy had a price tag of $1,297 a month when it was first launched. According to industry experts, if tirzepatide secures FDA approval, Lilly will likely have to price it competitively to make sure insurance companies will cover it. s Qsymia (phentermine-topiramate) and Currax Pharmaceuticals’ Contrave (naltrexone-bupropion).

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Trials Drugs FDA Approval Clinical Trials 98

XTalks

DECEMBER 21, 2022

Bluebird bio is a notable mention as it secured FDA approvals for two of its gene therapies, Zynteglo and Skysona. The multi-million-dollar price tags are largely attributable to the high R&D and manufacturing costs associated with making a gene therapy, as the raw materials for producing the therapy can be expensive.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

Pharmacy Checkers

FEBRUARY 21, 2020

Those contracts are based on NDC numbers, unique codes tagged to the drug package. Businesses that tried to do this — buying FDA-approved drugs in a foreign market and labelling them in accordance with FDA rules and re-selling them in the U.S — rubbed up against intellectual property and misbranding rules. exported here and sold in U.S.

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Drugs FDA Approval Manufacturing Pharmacy 61

XTalks

MARCH 22, 2023

How has Pfizer secured their spot? In addition, nearly half of all new drugs launched between 2020 and 2021 came with a price tag of $150,000 per year, or more. Increased competition from generics and biosimilars has also prompted widespread change within the industry.

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

AUGUST 26, 2022

It’s a major step forward for BioMarin after its first attempt to secure approval for Roctavian in the US was knocked back, with the FDA rejecting its application in 2020 with a request for more data on the durability of its effects. BioMarin has said Roctavian will be available at a ‘net’ price of around €1.5

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Gene Therapy Gene Antibody Marketing 110

Delveinsight

JULY 22, 2020

The hospital inventory is equipped with tagged sensors. Data Security & Privacy. Data Security & Privacy is one of the challenges that Internet-based services regularly face. Medical Equipment Tracking. IoT can also be utilised in equipment tracking and management.

Doctors 59

Doctors Doctor Marketing Production 59

pharmaphorum

NOVEMBER 28, 2022

“Researchers can now leverage privacy-preserving and secure federated learning software to drive cutting-edge collaborative medical research. Owkin is committed to unlocking the vast potential held within patient data by developing technologies that overcome the privacy and security challenges that until now impacted research.”.

Pharma Companies 71

Pharma Companies Life Science Research Development 71

pharmaphorum

OCTOBER 4, 2022

The trio are charged with helping to enrol patients across more than 100 clinical sites in the US, with the purpose of engaging and educating study volunteers on the process, collecting the patient information accurately and securely, and enrolling patients onto the project itself.

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Biobanking Clinical Trials Clinical Trials Trials 94

Pharma Packaging Solutions

APRIL 21, 2021

Offering small-to-large production runs, Carton Service has expertise in: UV printing and UV coating production, in-line vision systems, quality operating system procedures, and specialty converting applications such as security tags, milk and foil stock converting, embossing and direct contact food carton production. 800.533.7744.

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Packaging Packaging Containment Pharma Packaging 52

The Pharma Data

MAY 13, 2021

Click here to get Spade SB-66 at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. After all, the ingredients we’ve chosen to include in Spade SB-66 are premium ingredients and come with a hefty price tag.

Packaging 52

Packaging Packaging Containment Production 52

The Pharma Data

MAY 15, 2021

Click here to get PentagonFit Fitness Tracker at discounted price while it’s still available… All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors. Web Beacons are tags that can monitor the behavior of a user visiting the Website or sending an e-mail.

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Production Containment Medicine Vaccination 52

Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. Secure, cloud-based informatics solutions are becoming more prominent to facilitate communication between labs.

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Reagent Antibody Drugs Protein 52

The Pharma Data

MAY 4, 2021

Pfizer recorded $1.0 Adjusted cost of sales, Adjusted selling, informational and administrative (SI&A) expenses, Adjusted research and development (R&D) expenses and Adjusted other (income)/deductions are income statement line items prepared on the same basis as, and therefore components of, the overall Adjusted income measure.

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Vaccination Vaccine Production Sales 40