pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

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pharmaphorum

JULY 23, 2019

Overview Join our live webinar taking place on Tuesday 23rd July at 16:00 BST / 11:00 EST / 08:00 PST. The expert panel will consider exclusive research carried out by Tag and pharmaphorum across the US, Europe and Asia-Pacific among senior decision-makers in pharma and FMCG marketing.

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Rethinking Clinical Trials

JULY 9, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds June 16, 2023: BeatPain Utah: Partnering With Community Health Centers Within a Socio-Technical Framework (Julie Fritz, PT, PhD, FAPTA; Guilherme Del Fiol, MD, PhD) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

APRIL 18, 2023

The first trial will begin enrolling in July 2023. Tags #pctGR, @Collaboratory1 The post Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH) appeared first on Rethinking Clinical Trials. It’s all over the place.

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Rethinking Clinical Trials

JULY 22, 2022

The post Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Read more in Annals of Internal Medicine and Critical Care Medicine. View the Summary of NIH-Funded ACTIV/ACTIV-Associated Clinical Trials. pctGR, @Collaboratory1.

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Rethinking Clinical Trials

AUGUST 22, 2022

The post Grand Rounds July 8, 2022: Results From the COVID-OUT Trial, A Phase-3 Trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine (Carolyn Bramante, MD, MPH; Thomas Murray, PhD; Jared Huling, PhD) appeared first on Rethinking Clinical Trials. We also kept equal focus on follow-up.

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Rethinking Clinical Trials

JULY 27, 2022

The post Grand Rounds July 22, 2022: ACTIV-6: 1-Year Later and Trial Results for Ivermectin-400 and Inhaled Fluticasone (Susanna Naggie, MD, MHS) appeared first on Rethinking Clinical Trials. For ACTIV-6, if we had not had a call center we would not have gotten the word out as much and participation would not have been as robust.

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Rethinking Clinical Trials

FEBRUARY 13, 2023

The recruitment began in July 2017-April 2022 and 71 percent of approached parents provided consent. Tags #pctGR, @Collaboratory1 The post Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease – Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

AUGUST 3, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine? Bergstrom, PhD) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

JULY 13, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds July 7, 2023: Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study (Ankeet S. There are a lot of programs that are aimed at this type of intervention at Kaiser but not one with a virtual intervention.

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The Pharma Data

AUGUST 18, 2020

Since July, the company has been running the therapy through Phase 1/2 studies to evaluate its efficacy in generating anti-tumour responses in locally advanced or metastatic solid tumours when used as a monotherapy and in combination with PD-1 inhibitors. .

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FDA Law Blog

JULY 20, 2021

By Riëtte van Laack — On July 1, 2021, the Federal Trade Commission (FTC) announced the availability of the pre-publication of the final rule on “Made in USA” (MUSA) claims in the Federal Register. The final rule was published on July 14, 2021. We previously reported on events that resulted in this rule.

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Pharmaceutical Technology

FEBRUARY 22, 2023

Developed by Sanofi and Regeneron, Praluent was approved by the FDA in July 2015. Both drugs come with a high price tag. Amgen’s Repatha was greenlit a month later. Both drugs are monoclonal antibodies that inhibit the protein PCSK9.

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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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XTalks

NOVEMBER 3, 2022

In its first quarter on the market since its approval, sales totalled $97 million between July and September in the US. 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. In the third quarter of 2022, Mounjaro scored $187.3

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Rethinking Clinical Trials

JULY 19, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. That might be an important jumping point for the second leg of COORDINATE-Diabetes to answer questions such as: How do you get payers and Medicare to sustain these interventions? Granger, MD; Neha J.

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pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. It was backed by NICE for NHS use in July 2018. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

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XTalks

JUNE 28, 2023

million price tag of Elevidys, a one-time gene therapy. It is injected into a patient’s muscle tissue. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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pharmaphorum

AUGUST 18, 2022

million price tag attached to the therapy when it was first made available in Europe, and is also well above the proposed $2.1 million level that cost-effectiveness organisation ICER said would be acceptable in a July report. bluebird has opted to launch it at a cost of $2.8 million, which compares to the $1.7

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pharmaphorum

JUNE 2, 2021

million price tag make it is the most expensive treatment ever approved for NHS funding, as it provides “exceptional benefit” to babies with the disease. “We will continue to work closely with the company to help them address the committee’s concerns ahead of its next meeting”, which is scheduled for 13 July. .

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XTalks

JUNE 9, 2021

Aducanumab Controversy and Price Tag. After this, Biogen completed its submission to the FDA in July 2020 for a Biologics License Application for approval of the drug. Evidence for aducanumab’s efficacy has been highly contested. Since then, many in the Alzheimer’s world were awaiting the FDA’s decision on the drug.

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XTalks

AUGUST 23, 2021

“This is not a debate on approval,” said Stacie Weninger, PhD, president of the F-Prime Biomedical Research Initiative, in a focused topic session on the impact of drug approval on future clinical trials held on Tuesday July 27. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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Clinical Trials Clinical Trials Trials Drugs 52

Intouch Solutions

JULY 27, 2021

The second and third events were outlined in a July JAMA Health Forum article by Dr. Michelle Mello of Stanford and Dr. Stacie Dusetzina of Vanderbilt. Department of Health and Human Services (HHS) has been given 45 days (from July 9) to submit a plan that addresses the issues noted above. In the meantime, legislation ( S.

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Rethinking Clinical Trials

AUGUST 28, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds July 21, 2023: Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons from IMPACt-LBP (Christine Goertz, DC, PhD; Adam Goode, DPT, PhD) appeared first on Rethinking Clinical Trials.

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Rethinking Clinical Trials

AUGUST 4, 2022

The trial has enrolled 1,900 high-risk non-hospitalized and 84% of patients were vaccinated to some extent, from July 2021-Feb 2022. The post Grand Rounds July 29, 2022: Effect of Early Treatment With Single-Dose Pegylated Interferon Lambda Among Patients With COVID-19: Results From The TOGETHER Trial (Edward Mills, PhD, FRCP; Jeffrey S.

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XTalks

FEBRUARY 11, 2021

Born in Notting Hill, London, England to a prosperous British Jewish family on July 25, 1920. They conducted two experiments, one with radioactive phosphorous to label DNA, and one with radioactive sulfur to tag protein (DNA does not contain sulfur and protein does not contain phosphate groups).

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The Pharma Data

MAY 4, 2021

Pfizer made an additional investment of $50 million in common stock of BioNTech as part of an underwritten equity offering by BioNTech, which closed in July 2020. Pfizer also made an equity investment of $113 million in BioNTech common stock. On January 29, 2021, Pfizer and BioNTech signed an amended version of the April 2020 agreement.

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