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

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.

Regulation 124

Regulation Medicine Pharma Companies Clinical Trials 124

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.

Vaccination 264

Vaccination Vaccine Regulation Medicine 264

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

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).

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

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?

Medicine 59

Medicine Protein Containment Drugs 59

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

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

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.”.

Vaccination 214

Vaccination Vaccine Immune Response Clinical Trials 214

Drug Discovery World

FEBRUARY 12, 2024

Why has there been so little progress in medicine? 7 Human biology-based research At Safer Medicines Trust, we believe that using human biology-based research is the best way to develop safe and effective treatments for patients. Clinical impact of high-profile animal-based research reported in the UK national press.

Medicine 59

Medicine Genome Genomics Drugs 59

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

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.

Medicine 52

Medicine Scientist Production Regulation 52

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.

Vaccination 277

Vaccination Vaccine Immune Response Antibody 277

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

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 141

Trials Clinical Trials Clinical Trials Medicine 141

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 Containment 52

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

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.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Containment 130

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.

Regulation 52

Regulation Containment Genetics Clinical Trials 52

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.

Medicine 40

Medicine Clinical Trials Clinical Trials Containment 40

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

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

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

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 108

Clinical Trials Clinical Trials Trials Development 108

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.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

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 130

Trials Medicine Clinical Trials Clinical Trials 130

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 109

Clinical Trials Clinical Trials Trials Clinical Research 109

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.

FDA Approval 98

FDA Approval Medicine Vaccination Vaccine 98

Sciensano

MARCH 27, 2024

Although several health authorities warned the public against using this medicine outside clinical trials, the medicine was widely used on a major scale in late 2020 and in 2021. These illegal medicines are mostly sold through foreign online shops or online marketplaces.

Contamination 52

Contamination Bacteria Packaging Packaging 52

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

Drug Discovery World

JANUARY 31, 2024

Vera Therapeutics has announced positive 72-week data from the open label extension (OLE) period of its Phase IIb ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN). In aggregate, the 72-week data with atacicept are consistent with a profile of true disease modification in IgAN.

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 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

The Pharma Data

DECEMBER 23, 2020

Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nev. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. All study subjects will receive the same Ampligen treatments.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

WCG Clinical

JULY 12, 2023

The report provides a 360-degree review of what motivates or deters potential volunteers from participating in clinical trials, and what steps can be taken to encourage more participation, particularly among underrepresented groups. Avoca joined the WCG family of companies in April 2021.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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. Reference: Chung DC, et al.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

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