Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated products. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

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Regulation Production Clinical Trials Clinical Trials 154

Rethinking Clinical Trials

OCTOBER 27, 2022

Duke Clinical Research Institute. Should social media for teenagers be regulated like a digital therapeutic, given how addictive they are and the behavior modification. Beyond privacy: A deeper understanding of the internet is required to protect digital trial participants. Eric Perakslis, PhD. Andrea Downing. Discussion Themes.

Clinical Research 130

Clinical Research Research Clinical Trials Clinical Trials 130

XTalks

FEBRUARY 27, 2024

Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial. 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.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

Rethinking Clinical Trials

JANUARY 19, 2023

Many pragmatic clinical trials are conducted with waivers of informed consent, but when vulnerable populations are subjects in research, there may still be additional important considerations, such as outreach, identifying caregivers through the medical record, and being certain a diagnosis of dimension has already been disclosed to the patient.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

Drug Discovery World

JANUARY 30, 2024

Lentivirus strategies are one of the most widely used tools in biomedical research and clinical testing, says Stella Vnook, CEO, Likarda. “Dr Streamlining trial designs and regulatory pathways can help. Increased clinical data and evidence of cost-effectiveness can improve coverage.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. Auvelity is the first drug Axsome has taken through to regulatory approval, but could be the first of a string of new products for the company, according to Tabuteau.

Drugs 96

Drugs FDA Approval Production Marketing 96

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. Wegovy had a price tag of $1,297 a month when it was first launched. percent and 22.5

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

pharmaphorum

MAY 17, 2021

There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see a sufficient benefit with Alexion’s Soliris (eculizumab) or Ultomiris (ravulizumab), but the regulator opted for a broad indication that included first-line treatment for PNH. billion and $1.1

Drugs 52

Drugs FDA Approval Marketing Clinical Trials 52

Intouch Solutions

APRIL 11, 2024

Pre-Clinical : Deeper comprehension of the impacts and outcomes associated with a particular drug. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials. Manufacturing : Improved operations, efficiency, and production costs. Regulatory limitations, especially in certain countries.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

The Pharma Data

MARCH 23, 2022

Unfortunately, in a Phase 3 clinical trial, treatment with remdesivir did not make a difference in mortality for Ebola virus disease patients. This special enzyme, once fused to Ebola virus polymerase, enables the polymerase to add a molecular tag to any other protein it interacts with.

Protein 52

Protein Genome Genomics Research 52

XTalks

MARCH 22, 2023

However, this consolidation of power hasn’t been isolated to the drug companies themselves; contract research organizations (CROs) have also been coming together to form clinical trial powerhouses over the last decade. In 2015, LabCorp acquired Covance , and Quintiles and IMS Health formed a joint venture in 2016, dubbed IQVIA.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

MAY 4, 2021

In addition, we have achieved important clinical, regulatory and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 to the world. Clinical and Research Developments. Hospital products, which grew 10% operationally to $2.3

Vaccination 40

Vaccination Vaccine Production Sales 40