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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Drug Discovery World

AUGUST 4, 2022

It may seem counterintuitive to spend time and money on planning for containment and delivery systems for a drug in the earliest stages of discovery when the chances of that molecule making it to market are still quite low. However, starting early can greatly improve the efficiency and speed of the development process. Testing compatibility.

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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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Advarra

FEBRUARY 24, 2023

In most cases, the results you are really looking for and trying to prove in a trial can be complex. One area receiving increased focus from the Food and Drug Administration (FDA) are trial designs incorporating multiple endpoints to support efficacy. All key questions to consider and address before the therapy even leaves the lab.

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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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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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Pharmaceutical Technology

NOVEMBER 9, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 Each booster dosage contains 15?g 1 vaccine as well as the safety results from a clinical trial underway.

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Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. MIT research 4 tells us a hard truth: about 95% of these trials fall short, leaving behind a trail of broken hopes for cancer patients each year.

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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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Drug Discovery World

OCTOBER 31, 2023

UK regulatory authorities have approved the first trial of a gene therapy for young children with Hunter syndrome. Following successful engraftment of modified HSCs in the bone marrow, these cells start to produce daughter blood cells which contain the IDS gene and enzyme which are distributed throughout the body, including the brain.

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pharmaphorum

SEPTEMBER 2, 2020

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. The concern is that UK patients will face delays to receiving the latest medicines because of the changes to the regulatory system.

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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. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

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Rethinking Clinical Trials

DECEMBER 12, 2023

It has been studied in prior contexts in a PCORI trial and a pilot inpatient trial where the intervention increased goals of care discussions from 8% to 21%. Jumpstart is a pragmatic randomized trial of Jumpstart compared to usual care. In some previous trials we have randomized at the clinician level.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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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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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. The post Elon Musk’s Neuralink brain interface chip set for human trials appeared first on.

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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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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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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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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

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). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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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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Drug Discovery World

SEPTEMBER 4, 2023

In the third and final part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates therapeutic breakthroughs using plant-based products in drug discovery. References [link] [link] [link] [link] The post Where is the promise for plant-based medicines?

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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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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.,

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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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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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Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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Drug Discovery World

AUGUST 3, 2023

In the first part of this series of articles focused on plant-based medicines, DDW’s Megan Thomas evaluates the use of medical cannabis in drug discovery. Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance.

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Drug Discovery World

FEBRUARY 12, 2024

There was great fanfare recently for a new Alzheimer’s drug, lecanemab (brand name Leqembi), which was shown in a trial to reduce the rate of cognitive decline in people with mild impairment. Why has there been so little progress in medicine? This was confirmed in human trials and the drug was subsequently approved by the FDA.

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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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The Pharma Data

DECEMBER 23, 2020

Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. The Ampligen EAP protocol is authorized to enroll up to 100 active trial participants, 20 of whom may be Long Haulers. and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev. AIM ImmunoTech Inc.

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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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The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). Source link.

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The Pharma Data

NOVEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, today announced that it has received a response from the U.S. About Praxis.

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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. percent and 22.5 percent, respectively, compared to placebo.

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Drug Discovery World

FEBRUARY 7, 2024

This submission brings us one step closer to the possibility of offering these patients a treatment that demonstrated improved survival and slowed disease progression compared to platinum-containing chemotherapy.” The sNDA is based on results from the Phase III EV-302 clinical trial.

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