Camargo

SEPTEMBER 14, 2021

An IND submission serves as a request to start clinical studies, containing a summary of information known about the drug, including nonclinical studies; chemistry, manufacturing and controls (CMC); and a proposed clinical plan. INDs must contain full study reports of nonclinical and clinical (if available) studies.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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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.

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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.

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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.

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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.

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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.

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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

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Pfizer

JULY 19, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 is immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of July 19, 2022.

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Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted

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Pharmaceutical Technology

APRIL 12, 2023

HyQvia is a liquid medicine containing recombinant human hyaluronidase and immunoglobulins (Ig). The expanded regulatory approval was based on the data obtained from an open-label, pivotal, non-controlled, prospective Phase III clinical trial conducted in 44 PI patients aged between two years and 16 years.

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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.

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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.

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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.

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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.

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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.

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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!

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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.”

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pharmaphorum

JUNE 9, 2022

Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

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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.

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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.

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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.

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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.

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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.

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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. .

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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.

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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.

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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.

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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.

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Roots Analysis

FEBRUARY 28, 2024

Cell Therapy pipeline update, Talaris Therapeutics , a late-clinical stage biotechnology company based in Boston, MA and Louisville, KY , announced the initiation of FREEDOM-1 ( NCT03995901 ), the company’s Phase 3 clinical trial of FCR001 in living donor kidney transplant (LDKT) recipients.

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Druggist

APRIL 16, 2021

Throat numbing lozenges contain a local anaesthetic which numbs the area and hence help with pain and irritation. This post list all sore throat lozenges containing a local anaesthetic available in the UK. Sore throat lozenges, which contain a local anaesthetic as an active ingredient, are classified as pharmacy-only products (P).

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XTalks

SEPTEMBER 28, 2023

XTALKS WEBINAR: A Step-by-Step Approach to eSource in Clinical Trials Live and On-Demand: Thursday, October 26, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to adopt an incremental approach to eSource (EHR to EDC integration) across multiple trial scenarios to overcome real and perceived challenges.

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pharmaphorum

MAY 4, 2022

The low rate of success is one of the contributors to the high cost and the slow R&D process that takes promising compounds through early testing and into the clinic. The challenge that the pharma industry faces is the lack of better alternatives to animal models. Organ-on-a-chip.

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Druggist

MAY 12, 2021

Celevac is a brand of tablets containing methylcellulose. Each Celevac tablet contained 500mg of methylcellulose. Celevac tablets were licensed as general sale list medicines (GSL), which means they could be sold in any retail outlet, including pharmacies, over the counter without a prescription. . What is Celevac?

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pharmaphorum

AUGUST 31, 2021

Many of our innovative life sciences partners pre-socialise their ECA strategy in early discussions with the FDA before finalising the clinical trial to get feedback on the approach from the ultimate decision maker. Myth 3: RWD is too imperfect to be used to as a comparator arm to a clinical trial.

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XTalks

SEPTEMBER 8, 2020

AZD1222 is now in Phase III clinical trials which will enroll approximately 30,000 adult volunteers in 80 states in the US, to determine whether the vaccine can help prevent symptomatic coronavirus disease from spreading. AstraZeneca, a UK-based global pharmaceutical company, is leading the COVID-19 trial as a regulatory sponsor.

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pharmaphorum

JANUARY 3, 2023

SPK-9001 is a novel, investigation vector containing a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene. The clinical trial participants will be evaluated as part of a long-term study over 15 years.

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