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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XTalks

FEBRUARY 27, 2024

Developed by Reata Pharmaceuticals, which Biogen acquired later that year, it is the first and only treatment for the condition, which is classified as an ultra-rare neuromuscular condition that damages the nervous system to affect movement. Both therapies were awarded their approvals on the same day in December 2023.

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Research Drugs Gene Therapy Clinical Trials 59

XTalks

APRIL 18, 2024

This test, which is being co-developed with Eli Lilly, has the potential to facilitate earlier and more accurate detection of the disease. The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

Rethinking Clinical Trials

JULY 6, 2023

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

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Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

MAY 10, 2023

Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. We are looking forward to supporting more.

Medicine 130

Medicine Research Clinical Trials Clinical Trials 130

Drug Discovery World

JANUARY 30, 2024

Natalia Elizalde, Chief Business Development Officer, VIVEbiotech, says that Dr Naldini’s award represents the significant benefits and demonstrated safety of the therapies developed using lentiviral vectors that are being used for more and more clinical trials and more prevalent diseases.

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Gene Therapy Manufacturing Gene Clinical Trials 71

XTalks

SEPTEMBER 27, 2022

With a list price of $3 million and a recent accelerated US Food and Drug Administration (FDA) approval, bluebird bio’s gene therapy Skysona (elivaldogene autotemcel, eli-cel), has officially become the world’s most expensive drug. The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it.

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FDA Approval Gene Therapy Drugs Gene 52

pharmaphorum

JANUARY 18, 2022

The hope is that they will harness and re-programme natural cellular mechanisms to selectively remove the disease driving proteins from human tissues, working by boosting interactions – gluing – between therapeutically relevant proteins and the machinery used by cells to naturally tag and destroy proteins.

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Dermatology Protein Pharma Companies Research 52

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 has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns.

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Gene Therapy Gene Protein FDA Approval 98

XTalks

FEBRUARY 14, 2023

Spending on the nutrition title alone is expected to push the price tag for the next Farm Bill to more than $1 trillion over the next ten years. Rural development: The US Department of Agriculture (USDA) is the only federal agency with the explicit mandate of deploying programs to help the development of rural areas.

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pharmaphorum

MAY 10, 2022

As with Aduhelm (aducanumab), lecanemab is being filed via the accelerated approval pathway, with the companies seeking a green light on the strength of the results of a phase 2b trial ahead of the readout of the confirmatory Clarity AD trial, due in the autumn.

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XTalks

FEBRUARY 27, 2024

Related: FDA Issues Letters to CAR T-Cell Therapy Makers to Include Boxed Warning Amtagvi was approved through the FDA’s Accelerated Approval pathway. Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.”

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

JULY 12, 2021

head of research and development at Biogen, in a statement from the company. The lawmakers are planning to find out what led to the FDA’s accelerated approval and wide label indication of Biogen’s Alzheimer’s drug.

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Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

SEPTEMBER 15, 2020

Pharma’s go-to-market strategies have tended to be more traditional than those seen in non-regulated sectors, but there are some signs this is changing, with an acceleration in the pace of change forced by the COVID-19 pandemic that is allowing the industry to close its gap with faster, more nimble consumer brands. Jeremy Richter, Tag.

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Branding Marketing Pharma Companies Life Science 120

pharmaphorum

OCTOBER 29, 2021

Rival drug Tecentriq (atezolizumab) – had its accelerated approval in first-line TNBC withdrawn by developer Roche in the US after failing a confirmatory trial, but is in late-stage testing as a treatment for early-stage TNBC. The post Gilead tags Merck for first-line triple negative breast cancer trial appeared first on.

Trials 52

Trials Sales FDA Approval Production 52

XTalks

JUNE 9, 2021

This Monday, the US Food and Drug Administration (FDA) granted accelerated approval to the drug for the treatment of the disease. Under the FDA’s accelerated approval pathway , Biogen has several years to conduct a required confirmatory post-approval clinical trial. Aducanumab Controversy and Price Tag.

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Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

JANUARY 21, 2022

Access to medicines is “one of the most challenging policy areas in every country in the European region” – it’s time to develop a solution that works for everyone. Medical science is accelerating at a tremendous rate, leading to profound changes in the treatment landscape for many diseases over the last decade. “It

Medicine 52

Medicine Marketing Manufacturing Production 52

The Pharma Data

OCTOBER 9, 2021

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. Roche’s Chief Medical Officer and Head of Global Product Development.

Antibody 52

Antibody In-Vitro Trials Development 52

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

XTalks

DECEMBER 21, 2022

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. The majority of gene therapies approved and under development are in the areas of oncology and rare disease.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

pharmaphorum

JUNE 2, 2022

In 1983, the US Congress passed the Orphan Drug Act to encourage more pharmaceutical companies to engage in R&D to develop treatments for rare diseases through the offering of financial incentives. As covered in a previous article , the importance of R&D to develop treatments for rare diseases is high. The price is right.

Drugs 52

Drugs Sales Marketing Development 52

Drug Discovery World

OCTOBER 3, 2022

She also works on her own research following her PhD in the digitisation of scientific research, smart labs and the lab of the future, and semantic tagging of scientific data, which she has continued as part of the Physical Sciences Data Infrastructure (PSDI) Project. Fellowship Programme. Fellowship Programme.

Drugs 52

Drugs Scientist Bioinformatics Medicine 52

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

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DNA Radiology FDA Approval Development 66

The Pharma Data

NOVEMBER 15, 2020

. Cytiva provides FlexFactory bioprocessing upstream and downstream solutions for Clover to accelerate GMP facility development and shorten time to market. Cytiva is a global life sciences leader with more than 7,000 associates across 40 countries dedicated to advancing and accelerating therapeutics.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

FDA Law Blog

JUNE 27, 2023

This includes both forging the application of the FDAMA 115 “single study plus confirmatory evidence” standard as well as expanding the use of accelerated approval for products in conditions outside of cancer. We are proud as a firm of this honor and would also like to extend congratulations to all of this year’s Law360 Rising Stars!

Life Science 81

Life Science FDA Approval Drugs Development 81

pharmaphorum

MAY 24, 2021

It is a newer concept for pharma marketers, however, who are now turning to modular solutions in response to the accelerated demand for content over the past year. Robb DeFilippis, managing director, life sciences, for end-to-end global creative production and sourcing partner Tag in the Americas agrees. ” Robb DeFilippis.

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Marketing Branding Sales Life Science 94

Drug Discovery World

APRIL 17, 2023

Totus uses molecular tags that track drug binding in individual cells to screen billions of drug molecules across thousands of genes in parallel, combined with machine learning techniques. The study will be conducted in two parts.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

XTalks

AUGUST 23, 2021

More than 125 drugs are still in the [Alzheimer’s disease] drug development pipeline,” said Dr. Grill. The fact that aducanumab received accelerated approval from the FDA based on a biomarker — reduction of amyloid — sets a clear precedent for Alzheimer’s clinical trials going forward. Will they drop out to take it?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Drug Discovery World

NOVEMBER 13, 2023

On Day 3, Thursday 16 November 2023, the tracks include: the second part of machine learning for protein engineering, antibodies against membrane protein targets, engineering bispecific antibodies, next-generation immunotherapies, protein stability and formulation, and protein process development.

Protein 59

Protein Antibody Engineer Scientist 59

Drug Discovery World

NOVEMBER 9, 2023

The first three include: Sungjin Park, PhD, CEO, Onegene Biotechnology, on: ‘UniStac: Enzyme-mediated conjugation technology for accelerated development of tetraspecific NASH drug’. Gail Calvert, Field Application Scientist, Sartorius UK, on: ‘Leveraging integrated and advanced technologies for successful cell line development’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

Drug Discovery World

FEBRUARY 9, 2023

At the same time, we are developing a better understanding of disease pathology, leading to a more complicated picture of how diseases manifest. The first is that in-roads made in decoding the complexity of human disease will make drug discovery more difficult and costly, limiting the potential to develop new life-saving therapies.

Drugs 52

Drugs Development Big Data Scientist 52

pharmaphorum

OCTOBER 4, 2022

Central to the initiative is the aim to gather data from willing participants that can provide greater insights into cancer development and treatment over time. The Moonshot was started with three aims: to accelerate scientific discovery in cancer, foster greater collaboration between stakeholders, and to improve the sharing of cancer data.

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Drug Discovery World

OCTOBER 21, 2022

A major breakthrough in the technology was the development of biologically active fluorescent reagents that could be detected by the instruments. 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. References: .

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Reagent Antibody Drugs Protein 52

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 previously $59.4

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Vaccination Vaccine Production Sales 40