Rethinking Clinical Trials

AUGUST 3, 2023

Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. Tags #pctGR, @Collaboratory1 The post Grand Rounds July 28, 2023: How Can Researchers Fight Misinformation About Medicine?

Medicine 100

Medicine Research Vaccine Vaccination 100

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use. Finding the best clinical trial packaging services providers.

Packaging 100

Packaging Packaging Marketing Clinical Trials 100

STAT News

JANUARY 19, 2023

We will leave it to you to guess what it contains. … The European Medicines Agency has not identified any safety signals in the region related to the updated Covid-19 booster shot from Pfizer and BioNTech , Reuters notes. Our choice today is a Mardi Gras blend. And how is your morning going?

Clinical Trials 97

Clinical Trials Clinical Trials Regulation Drugs 97

Druggist

NOVEMBER 6, 2020

Patients commonly request over the counter medicines for a chesty cough. In today’s post, I will seek to find the best medicine for chesty cough by looking at over the counter and pharmacy-only products available in the UK. The best evidence for or against the effectiveness of medicines comes from well designed clinical trials.

Medicine 69

Medicine Containment Production Pharmacy 69

STAT News

DECEMBER 12, 2022

However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results. The mutation is found in approximately 13% of lung tumors.

FDA Approval 98

FDA Approval Sales Drugs Clinical Trials 98

The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

pharmaphorum

SEPTEMBER 21, 2020

Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

Medicine 134

Medicine FDA Approval Clinical Trials Clinical Trials 134

Pharmaceutical Technology

AUGUST 5, 2022

It is ultra-rare,” says Jesús Rodriguez Requena, PhD, associate professor in the Department of Medicine at the University of Santiago de Compostela. According to GlobalData’s Pharma Intelligence Center, there are only six drugs in active development for CJD, of which only one has been in clinical trials.

Drugs 299

Drugs Protein Vaccine Vaccination 299

pharmaphorum

JANUARY 27, 2023

Developing medicines – for people living with disease Dr Mullen’s current role involves providing medical monitoring support, as well as safety, pharmacovigilance, scientific, and medical advice across a range of client projects, including advanced therapies and orphan drugs.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Development 111

pharmaphorum

JANUARY 27, 2023

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. The impact of burnout on clinical trials Each staff member involved in a clinical trial is essential to its success.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Clinical Research 111

Rethinking Clinical Trials

SEPTEMBER 13, 2023

The trial operated under an IRB waiver of informed consent with a patient information sheet. Patients were randomized 1:1 in blocks of variable size, stratified by trial site with allocation concealed until randomization using opaque envelopes containing trial group assignment. for the video laryngoscope group and 70.8%

Trials 111

Trials Clinical Trials Clinical Trials Medicine 111

The Pharma Data

JANUARY 10, 2021

11, 2021 (GLOBE NEWSWIRE) — Editas Medicine, Inc. Food and Drug Administration (FDA) has cleared the initiation of the safety phase of the Company’s EDIT-301 clinical trial, and the Company can begin dosing patients. EDIT-301 is the first experimental medicine in development generated using CRISPR/Cas12a gene editing.

Medicine 52

Medicine Development Clinical Trials Clinical Trials 52

Camargo

NOVEMBER 11, 2020

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. for patients with NTRK fusion cancer across all solid tumors.

Development 242

Development Bioequivalency Generic Drugs Production 242

Druggist

DECEMBER 17, 2020

Without a doubt, codeine-containing products are one of the most commonly sold medicines in the UK. Restrictions on the supply of codeine-containing products. The main focus of this post is to introduce the most common over the counter codeine-containing products in the UK and review their codeine content.

Production 98

Production Containment Pharmacy Licensing 98

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

pharmaphorum

DECEMBER 4, 2022

Clinical trials of a wireless brain chip developed by Elon Muck’s Neuralink company will be tested in human volunteers within the next six months – and Musk himself says he intends to have one implanted for a future demo event. Take action! Retweet this thread and tell @elonmusk to release the tapes!

Trials 118

Trials Clinical Trials Clinical Trials Containment 118

The Pharma Data

JANUARY 17, 2021

The medicine, an anti-SARS-CoV-2 immunoglobulin, given subcutaneously, would provide immediate protection after exposure to the virus and could be used to protect the elderly and healthcare workers. It could also help contain outbreaks in places where the vaccination hasn’t begun or is still underway.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

Camargo

NOVEMBER 29, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

Development 180

Development Protein Production Hormones 180

The Pharma Data

OCTOBER 25, 2020

NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease. . SOUTH PLAINFIELD, N.J. , Peltz , Ph.D.,

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

Pharmaceutical Technology

MAY 24, 2023

The regulator granted RMAT designation based on the data obtained from the ongoing Phase I RP-L301 clinical trial. Notably, PKD has an estimated prevalence of up to 8,000 patients in the US and Europe and represents one of the most significant patient opportunities in our LV haematology portfolio.”

Gene Therapy 130

Gene Therapy Gene Licensing Licensing 130

The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. Vaccine manufacturers have previously studied some variant vaccine candidates and are currently conducting clinical trials of Omicron-specific vaccines. Nadine Rouphael, M.D.,

Clinical Trials 52

Clinical Trials Clinical Trials Trials Immune Response 52

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

XTalks

JUNE 6, 2023

Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. The FDA’s approval of Posluma was based on two Phase III clinical trials, LIGHTHOUSE and SPOTLIGHT. How Does Posluma Work? Is Posluma Safe and Effective?

FDA Approval 96

FDA Approval Clinical Trials Clinical Trials Marketing 96

Camargo

APRIL 28, 2021

The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials. First Steps Toward Initiating Pediatric Clinical Studies.

Clinical Trials 130

Clinical Trials Clinical Trials In-Vivo Drugs 130

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Trials 52

pharmaphorum

MAY 24, 2021

Having gone from being an innovation buzzword to becoming a core part of drug assessment processes it offers health technology assessment (HTA) bodies a way to assess the value and impact of drugs outside of an artificial clinical trial setting. That’s not to say that clinical trials are redundant.

Drugs 83

Drugs Clinical Trials Clinical Trials Doctor 83

Advarra

FEBRUARY 24, 2023

One area receiving increased focus from the Food and Drug Administration (FDA) are trial designs incorporating multiple endpoints to support efficacy. Developing the endpoint design and overall approach of a clinical trial program is mostly science, but there is a bit of art to it as well.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

OCTOBER 2, 2020

UK-based Compass Pathways and its potential magic mushroom depression drug went public last month – and just a week later psychedelic therapy firm Mind Medicine announced it would be up-listing its shares on the Nasdaq. The past few weeks have seen a flurry of companies in this space announce that they intend to go public. .

Medicine 122

Medicine Life Science FDA Approval Development 122

pharmaphorum

OCTOBER 2, 2020

It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

Regulation 105

Regulation Vaccination Vaccine Protein 105

pharmaphorum

DECEMBER 7, 2020

Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Most portable vaccine carriers and cold containers cannot keep cold beyond 12 hours, especially if it is hot outside.

Vaccine 100

Vaccine Vaccination Clinical Trials Clinical Trials 100

Rethinking Clinical Trials

DECEMBER 12, 2023

In order to classify a patient with goals of care conversation, the study used the NLP to screen the records and pull out excerpts of EHR that had high probability to contain a goals of care conversation and then conducted a human review. EHR passages were adjudicated in pseudo-random order, blinded to patient ID.

Trials 100

Trials Medicine Clinical Trials Clinical Trials 100

Pfizer

AUGUST 3, 2022

The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac, renal and inherited metabolic disorders. Disclosure Notice. 07.13.2022.

Development 101

Development Vaccination Vaccine Production 101

Druggist

DECEMBER 28, 2020

Fexofenadine over the counter will be available as a branded product – Allevia 120mg tablets (each tablet contain 120mg of fexofenadine hydrochloride). When taken correctly, fexofenadine is unlikely to cause harmful side effects or interact with other medicines. Taking Allevia tablets with other medicines.

Pharmacy 98

Pharmacy Doctor Doctors Allergies 98

The Pharma Data

MAY 8, 2021

MYLIGHT is part of a comprehensive biosimilar development program including analytical, preclinical and clinical data. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine* in patients with nAMD 1. Disclaimer. About Sandoz.

Clinical Development 52

Clinical Development Medicine Development Containment 52

The Pharma Data

SEPTEMBER 23, 2020

We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”. “We With our vaccine candidate now in our global Phase 3 trial, we are one step closer to finding a solution for COVID-19. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52