pharmaphorum

APRIL 26, 2021

Using technologies such as VR and AI, the company aims to accelerate human growth and social rehabilitation in medical education and provide support for people with disabilities, as well as provide treatments for mental illness. The post Jolly Good/Teijin Pharma develop VR digital therapeutics for depression appeared first on.

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Development Medicine Production Marketing 121

Rethinking Clinical Trials

FEBRUARY 7, 2024

The spread of misinformation has accelerated, in part because more people than ever are accessing health information on the internet and via social media. This work is important because the digital health information environment and limited public trust in government institutions represent pressing challenges for FDA.

Regulation 152

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Rethinking Clinical Trials

FEBRUARY 28, 2024

I am sure NIH is trying to accelerate our understanding of DCTs. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. There has to be a range of approaches that could be fit for use.

Clinical Trials 141

Clinical Trials Clinical Trials Trials Clinical Research 141

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

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.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

AUGUST 10, 2023

Discussion Themes -It seems like the speed of AI use is accelerating and our awareness isn’t keeping up. Tags #pctGR, @Collaboratory1 The post Grand Rounds August 4, 2023: AI & ML: Want to Play a Game? The key is to have a deep understanding and control over the data being used. People need to be really focused.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

World of DTC Marketing

JUNE 23, 2021

Not to mention the $56,000 annual price tag. We think the decision is on very solid ground, that we are on very solid ground when it comes to the data and the rationale for utilizing accelerated approval to greenlight this drug.”.

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Drugs FDA Approval Doctors Doctor 218

Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. What happens after a drug gets an orphan drug designation? An orphan drug designation does not automatically translate into approval.

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Drugs FDA Approval Marketing Development 246

XTalks

FEBRUARY 27, 2024

Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

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.

Dermatology 52

Dermatology Protein Pharma Companies Research 52

Rethinking Clinical Trials

AUGUST 18, 2022

Achieving this goal will require sophisticated informatics-based recruitment tools and novel engagement approaches to accelerate recruitment and retention. The Trial Innovation Network Recruitment Innovation Center aims to positively impact human health by improving participant enrollment and retention in multi-center clinical trials.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Insulin 130

pharmaphorum

DECEMBER 17, 2021

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one.

Trials 52

Trials Sales Marketing FDA Approval 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. million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

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.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

World of DTC Marketing

DECEMBER 13, 2021

As cancer survival rates rise, so do the price tags of life-saving treatments. Few cancer drugs approved via the accelerated FDA approval pathway were judged to have verified benefits based on improvement in survival reported in confirmatory trials. OPENING: American cancer patients spent more than $21 billion on their care in 2019.

Drugs 55

Drugs FDA Approval Medicine Containment 55

XTalks

APRIL 18, 2024

According to the draft document, a reduction in amyloid levels could be used as a surrogate in clinical trials as a predictor of a drug’s potential benefits and could support an accelerated agency approval. 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

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.

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

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

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

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. On the other hand, Biogen is being aggressively questioned over its tacking on of such a hefty price tag for the drug.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

NOVEMBER 24, 2022

Johnson & Johnson’s Spravato therapy for treatment-resistant depression (TRD) hasn’t made the impact the company hoped for in the market, and it is looking to new clinical results to accelerate its take-up.

Trials 52

Trials Sales Drugs Marketing 52

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.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

JANUARY 21, 2022

Medical science is accelerating at a tremendous rate, leading to profound changes in the treatment landscape for many diseases over the last decade. “It 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.”.

Medicine 52

Medicine Marketing Manufacturing Production 52

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.

Packaging 98

Packaging Packaging Production Marketing 98

Drug Discovery World

JANUARY 30, 2024

Other Challenges: Limited insurance coverage: Many insurance companies are hesitant to cover CGTs due to their high price tags and limited long-term data. Fostering open innovation and collaboration could help address this issue. Increased clinical data and evidence of cost-effectiveness can improve coverage.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

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 8, 2021

Accelerated approval is probably a reasonable middle ground here. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on. Though good luck taking the drug off the market if future data doesn't support the its efficacy. — Brad Loncar (@bradloncar) June 7, 2021.

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Drugs Marketing FDA Approval Trials 98

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. Currently, CSL Behring’s one-dose Hemophilia B gene therapy Hemgenix holds the title at $3.5 million for a single infusion.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies. Roche’s Chief Medical Officer and Head of Global Product Development.

Antibody 52

Antibody In-Vitro Trials 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.

Drugs 52

Drugs Scientist Bioinformatics Medicine 52

pharmaphorum

JUNE 2, 2022

And of course, in many cases, these drugs have higher than average price tags compared to the wider market which is due to the limited – or in most cases – non-existent competition within a treatment area.”. Raising questions. The post Orphan drugs’ financial success raises questions appeared first on.

Drugs 52

Drugs Sales Marketing Development 52

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.

Marketing 94

Marketing Branding Sales Life Science 94

XTalks

JANUARY 19, 2024

Alpha Emitter Radioligand Therapy Versus External Beam Radiation Therapy External beam radiation therapy is generally delivered through a linear accelerator with photons or electrons. Xofigo (radium-223 dichloride), for instance, is used in the treatment of metastatic castration-resistant prostate cancer that has spread to bones.

DNA 66

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. SHANGHAI , Nov.

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. Duchenne, Friederichs’s Ataxia, Sickle Cell Disease, Chagas, ALS). Dormer Jeffrey N. Gibbs Paul M. Hyman Alan M. Mullen Frank J.

Life Science 81

Life Science FDA Approval Drugs Development 81

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