Pilot and Feasibility Testing: The LIRE Example
Rethinking Clinical Trials
JULY 31, 2023
Jerry Jarvik, principal investigator of the LIRE Demonstration Project, discusses pilot and feasibility testing in pragmatic clinical trials.
Digital health collaboration to trial AI-powered X-rays for lung cancer detection
Pharma Times
DECEMBER 18, 2023
Earlier diagnosis could increase patient survival rates by five years or more The University of Glasgow has announced that an artificial intelligence (AI)-enhanced chest X-ray reporting solution has begun trials in NHS Greater Glasgow and Clyde (NHSGGC) for early detection of lung cancer.
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The Utility of Liquid Biopsy in Oncology Clinical Trials
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). percent show less reliability).
AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis
The Pharma Data
MARCH 22, 2021
The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. The trial had a 2:1 randomisation of vaccine to placebo. The specific search for CVST found no events in this trial.
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Bayer delivers on medical innovation fueling transformation of pharma business
The Pharma Data
FEBRUARY 21, 2022
Our leadership in cardiology, radiology and women’s health is recognized worldwide, and we are expanding our presence in oncology, working tirelessly to bring forward new approaches that can change the treatment paradigm for patients,” said Stefan Oelrich, Member of the Board of Management, Bayer AG and President of Bayer’s Pharmaceuticals Division.
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Rezzayo (Rezafungin) Becomes First New Treatment Option for Candidemia and Invasive Candidiasis in Over a Decade
XTalks
MARCH 27, 2023
The first line of treatment for invasive candidiasis is a subset of antifungal medications called echinocandins, which includes caspofungin (brand name Cancidas), the drug that rezafungin was compared with in clinical trials. Once the fungus cannot synthesize β-(1, 3)-D-glucan, it undergoes osmotic instability and cell death.
Why I Fight | A message from Gary Fishbein, MD, MPH
Worldwide Clinical Trials
MAY 24, 2022
Join us as we celebrate cancer research awareness month and clinical trials awareness month. What I like about my role at Worldwide Clinical Trials is that feeling that I am close to the patient, as I am often involved in confirming the patient’s eligibility on the study, understanding how patients are responding to the drug.
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What will the 2023 drug discovery landscape look like?
Drug Discovery World
JANUARY 24, 2023
Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 In early November 2022, two Alzheimer’s drugs were tested head-to-head in a first-ever virtual clinical trial 3.
A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica
Delveinsight
DECEMBER 29, 2020
Audentes Therapeutics’ ASPIRO Trial Free to Proceed. The Food and Drug Administration (FDA) decided to lift the clinical ban from Audentes Therapeutics’ ASPIRO trial, which was aimed at investigating its AT132 for the treatment of X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. . The post A USD 4.2
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Heart Valve Collaboratory announces U.S. FDA participation in collaborative community
Scienmag
FEBRUARY 16, 2021
Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community” A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical […].
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Merck and Ridgeback Announce U.S. Government to Purchase 1.4 Million Additional Courses of Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
The Pharma Data
NOVEMBER 9, 2021
Still, the recommended cure for molnupiravir grounded on the Phase 3 MOVe- OUT clinical trial would be 800 mg doubly daily for five days, If authorized or approved.
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DiME digital measure is nocturnal scratch for atopic dermatitis
pharmaphorum
SEPTEMBER 8, 2022
The Digital Medicine Society (DiME) is today releasing a new set of open-access resources to advance the use of nocturnal scratch in the treatment of atopic dermatitis (AD). . It is hoped today’s event will serve as a “blueprint for the broader development and deployment of digital endpoints in medical product development”.
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American Roentgen Ray Society planning all-virtual 2021 Annual Meeting: April 18-22
Scienmag
SEPTEMBER 18, 2020
ARRS promises to deliver the same clinically relevant experience for which its Annual Meeting has long been heralded: world-class educational activities led by the field’s foremost experts that span every subspecialty of radiology Leesburg, VA, September 18, 2020–The American Roentgen Ray Society (ARRS) will convene its 2021 Annual Meeting (..)
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Unique ADHD Biomarkers Revealed from MRI Data from the Adolescent Brain Cognitive Development Study
XTalks
NOVEMBER 29, 2022
Last week , researchers at the Yale School of Medicine reported that they have identified brain biomarkers of attention-deficit/hyperactivity disorder (ADHD) in children. The study results will be presented at the Radiological Society of North America annual meeting , which is currently being held in Chicago, IL until December 1, 2022.
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Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19
The Pharma Data
MARCH 25, 2022
This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.(1). 2-4 Evusheld was generally well-tolerated in the trial.(2-4). 2-4 Evusheld was generally well-tolerated in the trial.(2-4). 2 Omicron SARS-CoV-2 subvariants in circulation around the world.(5-7)
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World Cancer Day 2024: Trends in Oncology Research and More
XTalks
JANUARY 26, 2024
Personalized medicine: One of the most exciting prospects of CRISPR/Cas9 in oncology is its contribution to personalized medicine. Clinical trials have demonstrated the potential of CRISPR/Cas9 in this field. Clinical trials have demonstrated the potential of CRISPR/Cas9 in this field.
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AZD1222 US Phase III primary analysis confirms safety and efficacy
The Pharma Data
MARCH 24, 2021
Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021. The NIAID-supported COVID-19 Prevention Network (CoVPN) participated in the trial. D8110C00001 1.
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Low-dose radiotherapy combined with immunotherapy eradicates metastatic cancer in mice
Bioengineer
JULY 15, 2021
“In clinical trials, we tend to go with the maximum tolerable dose, the idea being that radiation kills the cancer and the more we give, the better. . “In clinical trials, we tend to go with the maximum tolerable dose, the idea being that radiation kills the cancer and the more we give, the better. ” ###.
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Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population
The Pharma Data
MARCH 29, 2022
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months Evusheld retains neutralising activity against the Omicron BA.2 1-3 Evusheld was generally well-tolerated in the trial. 2 subvariant, now the dominant strain in Europe. Christoph D.
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News from AACR 2024: Sunday’s highlights
Drug Discovery World
APRIL 8, 2024
Outstanding Achievement Award Pfizer Chairman and CEO Dr Albert Bourla received the 2024 AACR Outstanding Achievement Award for Service to Cancer Science and Medicine on behalf of Pfizer during the Opening Ceremony.
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INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine
The Pharma Data
DECEMBER 23, 2020
Joseph Kim , President and CEO of INOVIO, said, “We are very pleased to share peer-reviewed Phase 1 clinical data for INO-4800 published in The Lancet’s EClinicalMedicine , and are grateful for the support of all participants and investigator staff involved in the clinical trial.” . mg and 2.0 mg and 2.0
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Bayer expands global clinical program for darolutamide in prostate cancer
The Pharma Data
MARCH 23, 2023
Darolutamide has already demonstrated efficacy and safety in nmCRPC with the Phase III ARAMIS trial, and in mHSPC with the Phase III ARASENS trial. The primary endpoint of this study is radiological progression-free survival (rPFS), measured by PSMA PET/CT assessed by independent central review.
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How IpsiHand Can Help Stroke Patients Regain Movement through Neurological Rehabilitation
XTalks
APRIL 27, 2021
Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a statement from the agency. This included data from an unblinded study of 40 stroke patients over a 12-week trial.
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FDA Approves Veklury (remdesivir) for the Treatment of COVID-19
The Pharma Data
OCTOBER 22, 2020
The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” said Barry Zingman, MD, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York.
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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration
XTalks
AUGUST 30, 2022
Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics?
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Getting approval will only be the first challenge facing lecanemab
pharmaphorum
SEPTEMBER 30, 2022
First and most obviously is the detailed data from the Clarity AD study reported this week, which will be revealed at the Clinical Trials on Alzheimer’s Congress (CTAD) in November. point advantage. “What we cannot know yet is whether that effect increases over time in an individual.
Who are the AACR Scientific Achievement Award winners?
Drug Discovery World
APRIL 14, 2023
Carl H June, MD, FAACR – Lifetime Achievement in Cancer Research June, a Fellow of the AACR Academy, is the Richard W Vague Professor in Immunotherapy, Director of the Center for Cellular Immunotherapies, and Director of the Parker Institute for Cancer Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania.
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Portable Neuromodulation Stimulator Gets FDA Authorization for MS Treatment
XTalks
MARCH 30, 2021
Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a press announcement from the agency. The first study was a randomized, double-blind, controlled trial consisting of 20 MS patients with gait deficits.
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A ‘Stunning’ Alternative Rx for Arthritic Joints?
The Pharma Data
NOVEMBER 19, 2020
At this point, the procedure is slowly becoming a more established treatment, said Dr. Felix Gonzalez, a radiologist at Emory University School of Medicine in Atlanta. And before the ablation is done, Gonzalez explained, patients go through what is basically a trial run. 29 to Dec.
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Novartis expands in radio-oncology again with $1.3bn Artios alliance
pharmaphorum
APRIL 7, 2021
billion-plus alliance with UK biotech Artios Pharma to develop precision medicines for cancer. Meanwhile, it also has a candidate in late-stage testing, called Lu-PSMA-617, which improved survival in PSMA-positive castration-resistant prostate cancer (CRPC) in a phase 3 trial last month and has been billed as a future blockbuster.
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Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
The Pharma Data
AUGUST 15, 2021
The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC. The major efficacy endpoint for the treatment of VHL-associated RCC was ORR measured by radiology assessment using RECIST v1.1 WELIREG is the first HIF-2?
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FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults
The Pharma Data
NOVEMBER 6, 2020
director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. Nightware is available by prescription only and is intended for home use.
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New analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirm robust efficacy and long-term prevention
The Pharma Data
NOVEMBER 18, 2021
Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset. In both PROVENT and Paraphernalia, AZD7442 was generally well permitted.
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AZD7442 reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial
The Pharma Data
OCTOBER 12, 2021
Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.
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Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19
The Pharma Data
JUNE 25, 2021
AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.
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Sunday 16 April at AACR Annual Meeting 2023
Drug Discovery World
APRIL 16, 2023
DDW’s Megan Thomas rounds up highlights from Sunday 16 April at AACR 2023, from promising trial results for a personalised mRNA-based cancer vaccine to winners of lifetime achievement awards.
AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.
The Pharma Data
AUGUST 22, 2021
The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.
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52 United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis
The Pharma Data
DECEMBER 8, 2020
Under the Orphan Drug Act, FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by FDA. Currently, there is no cure for IPF and only two drugs are approved in the United States to treat the condition.
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Patient-Reported Outcomes from the Positive Phase 3 monarchE Trial for Verzenio® at St. Gallen Virtual Congress 2021
The Pharma Data
MARCH 17, 2021
The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints. had fatal outcomes.
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Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals
XTalks
JANUARY 19, 2024
Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer. There have been more than $1.7
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AstraZeneca’s COVID-19 vaccine; Type 1 diabetes research updates; FDA nod to Zebra’s X-ray modelling AI; UniQure/CSL haemophilia B gene therapy curbs bleeding in phase 3
Delveinsight
DECEMBER 10, 2020
The full data from late-phase trials of AstraZeneca’s COVID-19 vaccine have pointed to the potential for AZD1222 to work after a single dose and limit asymptomatic cases; however, missed main questions regarding the efficacy of the candidate. In a pooled analysis of 11,636 participants enrolled in two separate clinical trials in the U.K.
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FDA accepts Pfizer’s Supplemental New Drug Applications for BRAFTOVI + MEKTOVI
The Pharma Data
APRIL 7, 2023
” These sNDAs are supported by results from the PHAROS trial (NCT03915951), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC.
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Tampa General Hospital is First in Florida To Offer Monoclonal Antibody Treatments to COVID-19 Patients
The Pharma Data
NOVEMBER 18, 2020
. “Effective delivery of this treatment can be logistically complicated,” said Dr. Kami Kim , director of the Division Infectious Diseases and International Medicine at USF Health Morsani College of Medicine. ” The monoclonal antibody is a man-made protein that acts like a human antibody in the immune system.
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AHA News: The Best Foods for Brain Health
The Pharma Data
DECEMBER 9, 2020
. “Of all the organs in our body, the brain is the one most easily damaged by a poor diet,” said Dr. Lisa Mosconi, director of the Women’s Brain Initiative and an associate professor of neuroscience in neurology and radiology at Weill Cornell Medicine and NewYork-Presbyterian Hospital. So, what does work?
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