Rethinking Clinical Trials

JULY 27, 2022

It is a decentralized, fully remote trial, and data are largely patient reported. The measured outcomes for ACTIV-6 are days of benefit and time to recovery/hospitalization and death. There were no differences observed in the relief of mild-to-moderate COVID-19 symptoms between patients taking Ivermectin-400 and the placebo.

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Trials Pharmacy Medicine Clinical Trials 173

Rethinking Clinical Trials

SEPTEMBER 28, 2023

Donabedian’s Quality Framework includes a structure that supports care, a process for the provision and receipt of care, and health outcomes, providing a process without a structure to support it. How might we better structure preventive visits? Adapted for early childhood preventive care, the structure should be team- and community-based.

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Trials Clinical Trials Clinical Trials Research 271

pharmaphorum

APRIL 14, 2022

million price tag. The FDA is currently reviewing beti-cel – also known as Zynteglo (betibeglogene autotemcel) – as a treatment for patients with beta thalassaemia who require regular blood transfusions. million if paid through an outcomes-based contract for patients with sustained transfusion independence.”

Gene Therapy 64

Gene Therapy Gene Marketing Clinical Trials 64

Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

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Clinical Trials Clinical Trials Trials Packaging 130

Rethinking Clinical Trials

SEPTEMBER 16, 2022

How are patients and families included in governance of learning within your LHS? One challenge is that academic medical institutions traditionally have multiple missions, including research, patient care, and education, and systemically integrating learning into clinical operations is novel addition to the traditional missions.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Research 100

XTalks

JUNE 28, 2023

Elevidys was granted FDA accelerated approval for the treatment of pediatric patients four to five years of age with DMD who have a confirmed mutation in the DMD gene. It is indicated for patients who do not have a pre-existing medical reason preventing treatment with the therapy. million price tag of Elevidys, a one-time gene therapy.

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Gene Therapy Gene Protein FDA Approval 98

pharmaphorum

OCTOBER 21, 2021

As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting that few patients are being treated with the $56,000 a year therapy. Biogen reported $1.6 million in sales for the drug in the second quarter.

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Sales Doctors Doctor Gene Therapy 120

Roots Analysis

JANUARY 28, 2024

Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.

Big Data 40

Big Data Medicine Marketing Clinical Trials 40

pharmaphorum

JUNE 12, 2022

Thursday saw the Cellular, Tissue and Gene Therapies advisory committee back elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD) – see our report here – and the following day it was the turn of betibeglogene autotemcel (beti-cel) for beta thalassaemia. The verdict on beti-cel is due from the agency by 19 August.

Gene Therapy 59

Gene Therapy Gene Marketing Trials 59

The Pharma Data

NOVEMBER 29, 2021

1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Effectiveness of current treatments : Corticosteroids and IL6 Receptor Blockers will still be effective for managing patients with severe COVID-19. On 26 November 2021, WHO designated the variant B.1.1.529

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Vaccination Vaccine Genome Genomics 52

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

Trials 52

Trials Sales Marketing FDA Approval 52

pharmaphorum

OCTOBER 29, 2021

Trodelvy has already established itself as a go-to therapy for TNBC patients whose disease has progressed after prior treatments, says Gilead, while Keytruda is approved as a first-line therapy for the cancer in combination with chemotherapy, in patients with PD-L1 scores of 10 or more. billion for the full year.

Trials 52

Trials Sales FDA Approval Production 52

pharmaphorum

JANUARY 31, 2023

This lack of trust in such a crucial industry can lead to decreased compliance, poor treatment adherence, and negative health outcomes for patients. Additionally, when patients are prescribed medication, they are often unaware of the mechanism of action, potential side effects, interactions, and contraindications.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Vaccination 52

pharmaphorum

JANUARY 5, 2021

The FDA’s breakthrough status is for tiragolumab plus Tecentriq is the first for a TIGIT drug, and covers the first-line treatment of patients with advanced-stage non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

Immune Response 52

Immune Response FDA Approval Drugs Sales 52

pharmaphorum

JUNE 2, 2022

Evaluate Pharma’s recent Orphan Drug Report subtitled its overview of the market ‘Niche no longer.’ By 2026, the report predicts that each of the top 10 selling orphan drugs will earn between $3 billion and $13 billion. This is why the action by the US in 1983 and subsequently the European Commission Regulation No. The price is right.

Drugs 52

Drugs Sales Marketing Development 52

Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care.

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Clinical Trials Clinical Trials Trials Research 130

Delveinsight

FEBRUARY 25, 2021

Quest runs 2,200 patient service centers and recruits 5,000 mobile phlebotomists who have experience and expertise in offering phlebotomy services for at-home visits. Working with Quest will help them support convenient access to blood collection for patients and healthcare providers.

DNA 52

DNA In-Vivo Genetics Medicine 52

Pharmaceutical Technology

JANUARY 27, 2023

The disorder has a reported annual incidence between 1.5 Before Cablivi’s approval, patients relied on a combination of plasma exchange plus corticosteroids and immunomodulators as the standard of care (SOC) for treatment. Hlávka says healthcare providers often ask, “Should we only pay for some of the patients?

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Manufacturing Drugs Research Analyst FDA Approval 130

Rethinking Clinical Trials

FEBRUARY 22, 2023

The biggest change is that the patient now has a seat at the table. Providers must now earn the trust of relatively informed and knowledgeable patients through a two-way conversation. Patients were enrolled via an app in this virtual trial. We are empowering the patient and family, who have access to their data.

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Clinical Trials Clinical Trials Trials Nurses 130

pharmaphorum

NOVEMBER 16, 2022

The advancements made in drug development over the last decade have seen the arrival of a number of treatments that offer one-time cures and more effective therapies for conditions in smaller patient populations. Advanced therapies have changed the treatment landscape for the industry and for patients. However, with a price tag of €1.58

Gene Therapy 131

Gene Therapy Gene Marketing Development 131

XTalks

FEBRUARY 27, 2024

Skyclarys (omobaloxone) was approved in 2023 for the treatment of adults and pediatric patients 16 years of age and older with Friedreich’s ataxia, a rare, neurological disease​​. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

XTalks

DECEMBER 21, 2022

This included greater adoption and acceptance of decentralized clinical trial models, emphasis on patient-centric approaches in trials, growing digitization of healthcare and dealing with drug manufacturing challenges. Gene Therapy Approvals. Manufacturer: Ferring Pharmaceuticals A/S. Manufacturer: bluebird bio, Inc.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

OCTOBER 4, 2022

A key part of this initiative was the establishment of the Cancer Moonshot Biobank, which will ask cancer patients to donate biospecimens and associated health information to aid research. The objective is to gather patient biospecimens longitudinally to understand how patients react to treatments and how cancer develops over time.

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Biobanking Clinical Trials Clinical Trials Trials 104

The Pharma Data

MAY 4, 2021

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS. First-Quarter 2021 Reported Diluted EPS (1) of $0.86, Adjusted Diluted EPS (2) of $0.93. Each of these accomplishments further demonstrates our commitment to Pfizer’s purpose: Breakthroughs that change patients’ lives.”. Reported Net Income (1). Reported Diluted EPS (1).

Vaccination 40

Vaccination Vaccine Production Sales 40