Pharmaceutical Technology

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1) versus the 50µg mRNA-1273 booster dose. 1 variant as well as the original 2020 strain.”.

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pharmaphorum

JUNE 14, 2022

Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical trials, leading to the FDA rejecting certain treatments and clarifying what is required for approval. China’s ambition to become a leader in the biopharma industry has been clear in the last few years.

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pharmaphorum

SEPTEMBER 14, 2020

Here he gives us a deeper look at how genomic medicine is evolving and the barriers that are preventing it from reaching its full potential. At that time, we thought this would be the holy grail for medicine. Now, however, the field is changing with respect to genomic medicine.

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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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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. FoundationOne ® Liquid CDx (Foundation Medicine; end-to-end commercial provider).

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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?

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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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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?

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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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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.

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Delveinsight

AUGUST 17, 2021

Few of the common adverse reactions observed in patients who underwent Keytruda and Lenvima combination in clinical trials are fatigue , diarrhea , musculoskeletal pain , hypothyroidism, hypertension , stomatitis , decreased appetite, rash, nausea and decreased weight.

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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.

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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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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%

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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

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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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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.

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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.

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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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Gene Therapy Gene Licensing Licensing 130

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

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.,

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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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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?

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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.

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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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