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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The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.

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pharmaphorum

DECEMBER 15, 2022

The company said QmTRIAGE can help alleviate a chronic shortage in radiology services around the world. It cites data estimating there is ten-fold higher demand for radiology services than available capacity, with around half of practitioners “experiencing depression or burnout” due to “unmanageable caseloads.”

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Radiology FDA Approval Licensing Licensing 59

The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. (Alume) announced today that it has been awarded a $2.5M About Alume Biosciences, Inc.

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Worldwide Clinical Trials

MAY 24, 2022

Join us as we celebrate cancer research awareness month and clinical trials awareness month. And they have Young Investigator Awards, which provide seed money for these young investigators as they’re developing their labs. Life after cancer is about more than just survival. Building Bridges. Every Patient Is Precious.

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XTalks

MARCH 27, 2023

The antifungal drug was approved under Priority Review based on its Qualified Infection Disease Product designation , an incentive to promote development of antifungals for life-threatening infections. The trial was a multicenter, double-blind, double-dummy, randomized Phase III trial across 66 tertiary care centers in 15 countries.

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Delveinsight

DECEMBER 29, 2020

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. . Audentes Therapeutics’ ASPIRO Trial Free to Proceed. Billion Myovant/ Pfizer Deal. mg) in the US and Canada.

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pharmaphorum

SEPTEMBER 8, 2022

Furthering DiME’s previous work on digital clinical measures, nocturnal scratch’s more widespread implementation aims to establish a firmer digital groundwork for future clinical research, technology development, and reimbursement decisions in the dermatological field, and thereby improve the lives of AD patients and caregivers.

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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.

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Clinical Trials Clinical Trials Drugs Trials 97

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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Radiology Vaccination Vaccine Trials 52

XTalks

JUNE 30, 2023

“The approval of Ultravist-300 and -370 in contrast-enhanced mammography gives physicians a new imaging option where conventional mammography might not be enough,” said Dr. Konstanze Diefenbach, head of Radiology Research and Development at Bayer, in the company’s news release. “We What is Contrast-Enhanced Mammography (CEM)?

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pharmaphorum

JANUARY 17, 2023

Greater Manchester has been selected as the site for the trial, as rates of lung cancer there are among the highest in the UK, said the partners. qXR has been trained on more than 2 million X-rays and their corresponding radiology reports, using deep-learning algorithms to interpret the images. The pilot will run for six months.

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Radiology Pharma Companies Trials Marketing 100

XTalks

SEPTEMBER 9, 2022

The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders. The SAINT Neuromodulation Trial. The FDA granted Breakthrough Device Designation to Magnus Medical for the SAINT technology back in November 2021.

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Radiology Life Science Licensing Licensing 98

XTalks

JANUARY 26, 2024

Key breakthroughs at the forefront include novel approaches to cancer treatment and diagnosis, the integration of artificial intelligence (AI) in oncology and the development of advanced preventive measures and care. Overcoming drug resistance: A major challenge in cancer treatment is the development of resistance to chemotherapy drugs.

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pharmaphorum

JANUARY 24, 2022

Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.

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Radiology Marketing Genome Genomics 111

pharmaphorum

SEPTEMBER 22, 2021

. “The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives,” said Tim Stenzel, director of the FDA’s office of in vitro diagnostics and radiological health.

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In-Vitro Radiology Regulation Trials 86

FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

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The Pharma Data

MARCH 23, 2023

1,2 Darolutamide is already approved under the brand name Nubeqa TM for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease as well as metastatic hormone-sensitive prostate cancer (mHSPC).

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XTalks

APRIL 27, 2021

The device is called the IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) and has been developed by Neurolutions Inc. , a medical device company focused on developing neurological rehabilitation solutions leveraging patients’ own brain activity to facilitate motor recovery and restore function.

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The Pharma Data

OCTOBER 1, 2021

The phase IV clinical trials , multicenter, controlled, cross-over study with corresponding blinded image evaluations met its primary endpoint, showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a one hundred pc dose of gadoterate (0.1 Dr. Olaf Weber, Head of Radiology Research and Development at Bayer.

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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. 1-3 Evusheld was generally well-tolerated in the trial.

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Antibody In-Vivo Vaccination Vaccine 52

The Pharma Data

MARCH 25, 2022

2-4 Evusheld was generally well-tolerated in the trial.(2-4). The half-life extension more than triples the durability of its action compared to conventional antibodies;(11-13) data from the PROVENT Phase III trial show protection lasting at least six months.(14) Evusheld was well-tolerated in the trials. W911QY-21-9-0001.

Antibody 52

Antibody In-Vivo Medicine Vaccination 52

Drug Discovery World

APRIL 8, 2024

Aviv Regev, Head and Executive Vice President of Research and Early Development at Genentech, opened the session with a discussion of how advances in genomic sequencing are fostering the development of data-rich cell atlases and what that data could mean for new insights into cancer biology and novel therapeutics.

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In-Vivo In-Vitro Antibody Protein 52

FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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Development Clinical Trials Clinical Trials Drugs 52

The Pharma Data

JANUARY 27, 2021

The good news is that, more recently, “our ongoing surveillance and research suggests that there has been a rebound in [cancer] trial launches,” Lamont said. “This study speaks to a big decline in the launch of new trials during the pandemic,” Schilsky noted. “Some trials never resumed and may never.

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Research Trials Radiology Scientist 52

Delveinsight

SEPTEMBER 27, 2021

It can be due to the previous existence of brain damage signs (psychomotor retardation, neurologic signs, radiologic signs, or other types of seizures) or on the basis of etiology that is characterized by a lack of previous signs of brain damage. Further, more than 50% of the patients develop long-term neurologic deficits.

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WCG Clinical

MARCH 17, 2023

But why is the coverage analysis process so vital for clinical trials and how can research sites do it more effectively? If most items cannot be billed to insurance and there are no funds to cover those costs, then it’s time to make a decision about the financial feasibility of conducting the trial.

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Compliance Clinical Trials Clinical Trials Trials 52

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? During the webinar, Dr. Vornov discussed a few developments in targeted CNS delivery, which are summarized below.

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Trials Drug Delivery Drugs Gene 83

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. Additionally, when tumor cells were reintroduced to the mice cured by the combination therapy, they quickly fought them off and did not develop cancer again. ” ###.

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Medicine Clinical Trials Clinical Trials Scientist 52

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.” . PLYMOUTH MEETING, Pa. ,

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The Pharma Data

OCTOBER 22, 2020

The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. to 2.48; p=0.017).

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The Pharma Data

NOVEMBER 9, 2021

Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. “ 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. Molnupiravir is being developed by Merck &Co.,Inc.

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Medicine Radiology Development Drugs 52

XTalks

MARCH 30, 2021

The device has been developed by Helius Medical Technologies and is approved in Canada and the EU, with the US now following suit with the FDA authorization. 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.

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Radiology Trials Marketing Containment 71

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. There will still be much debate about the exact license granted to the drug and cost-effectiveness deliberations, according to Prof Passmore.

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Clinical Trials Clinical Trials Sales Drugs 52

pharmaphorum

MARCH 31, 2021

Novartis hopes to use the biomarker to develop both imaging agents for cancer and potentially therapeutics to direct cell-killing radiotherapy to tumours. billion to buy targeted radioligand therapy Lu-PSMA-617 from Endocyte , shortly after encouraging results in a phase 2 prostate cancer trial. In 2018 it paid $2.1

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Licensing Licensing Gene Therapy Sales 98

Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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Genetics Research Medicine Clinical Research 52

XTalks

APRIL 6, 2021

The device, developed by world-leading medical technology company Medtronic , is indicated for both pediatric and adult patients who have severe pulmonary valve regurgitation. The condition causes blood to leak backward into the right lower chamber of the heart.

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