The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). . SILVER SPRING, Md. ,

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Drug Discovery World

JANUARY 24, 2023

The overall virtual clinical trials market is currently valued at $7.8 But Jeffrey Petrella, Professor of Radiology and Director of the Alzheimer Imaging Research Laboratory at Duke University School of Medicine, says: “Despite these limitations, this is the first step towards tailored clinical trials. So where to start?

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The Pharma Data

JUNE 28, 2021

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine.

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FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Thus, this part of the Act becomes that much more important to healthcare providers innovating in the field of medicine.

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The Pharma Data

MARCH 22, 2021

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. JPEO-CBRND.

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The Pharma Data

MARCH 24, 2021

In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. BARDA, ASPR, HHS. JPEO-CBRND.

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XTalks

APRIL 27, 2021

The US Food and Drug Administration (FDA) has authorized marketing of a new neurological rehabilitation device to assist in maintaining or increasing range of motion as part of muscle re-education in patients undergoing stroke rehabilitation. The device is approved for use in patients 18 years of age and older.

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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. . Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist.

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pharmaphorum

SEPTEMBER 30, 2022

According to Prof Peter Passmore, an ageing and geriatric medicine specialist at Queen’s University Belfast, the benefits “seem to be small and the debate will be around how clinically relevant the changes are in CDR SB.” point advantage. If approved, cost and reimbursement will be the next big challenges.

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pharmaphorum

AUGUST 4, 2020

In common with many of its peers, Bayer saw an uptick in pharma sales in the first quarter in part due to stockpiling of medicines as the coronavirus pandemic gathered momentum.

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The Pharma Data

DECEMBER 23, 2020

Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA). About INOVIO’s DNA Medicines Platform.

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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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Delveinsight

DECEMBER 10, 2020

Scientists at the University of Utah School of Medicine have found a way to control that autoimmune response by aiming a protein that is vital for T-cell activation. Warding off Type 1 diabetes by aiming a T-cell protein. The body’s immune system falsely attacks insulin-making beta cells in the pancreas in Type 1 diabetes.

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pharmaphorum

APRIL 7, 2021

billion-plus alliance with UK biotech Artios Pharma to develop precision medicines for cancer. billion in milestone payments plus royalties if any of them reaches the market. In its second licensing deal in the radio-oncology area in consecutive weeks, Novartis has agreed a $1.3 It’s also providing research funding.

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The Pharma Data

MARCH 23, 2023

The primary endpoint of this study is radiological progression-free survival (rPFS), measured by PSMA PET/CT assessed by independent central review. It is also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in a number of markets including the U.S., Japan, China and the EU.

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pharmaphorum

MAY 24, 2021

Alarmingly, 100,000 of those deaths came in the last month, and the latest wave of infections is threatening to overwhelm India’s healthcare system, with hospitals running out of essential supplies like oxygen and critical medicines. The post As India battles COVID, Qure.ai

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The Pharma Data

NOVEMBER 12, 2021

director of the FDA’s Center for Devices and Radiological Health. “We Analogous testing handed by Philips Respironics to the FDA on bias authorized for marketing in theU.S. which failed one safety test for the release of certain chemicals of concern, called unpredictable organic composites (VOCs). had demonstrated respectable results.

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XTalks

MARCH 30, 2021

An innovative new non-surgical medical device called the portable neuromodulation stimulator (PoNS) has received marketing authorization from the US Food and Drug Administration (FDA) as a treatment to help improve gait in patients with multiple sclerosis (MS). MS affects patients differently with respect to both symptoms and their severity.

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The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. The granting of an orphan drug designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

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XTalks

AUGUST 30, 2022

CNS drugs take more than a year longer to develop and are less than half as likely to receive marketing approval compared to other drugs, according to a 2014 study by the Tufts Center for the Study of Drug Development. Targeting the CNS directly has been successful in modern medicine. Why is it Difficult to Develop CNS Therapeutics?

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XTalks

NOVEMBER 7, 2022

The leaders in this space now are Foundation Medicine and Guardant360, which have a large number of FDA-approved companion diagnostic assays for different indications,” said Dr. Bahassi. FoundationOne ® Liquid CDx (Foundation Medicine; end-to-end commercial provider). Bahassi during the webinar and is shown in Table 1.

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The Pharma Data

AUGUST 5, 2021

Sales of prescription medicines (Pharmaceuticals) rose by 16.2 The growth in earnings was primarily driven by the division’s strong business performance and continuous cost management efforts while allowing for additional investments in marketing as part of new product launches and accounting for negative currency effects of 20 million euros.

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XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. Here again, the stock markets are functioning in a parallel universe. billion in June. ECONOMIC IMPACT: Canada.

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The Pharma Data

OCTOBER 14, 2020

The global heart failure market represents a tremendous opportunity for Sequana Medical and we look forward to providing an update on the interim results from our RED DESERT study later this year.”. Previously, he was Chief of the Heart Failure Section at Duke University School of Medicine from 2013 to 2020. About Dr. Felker G.

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The Pharma Data

APRIL 7, 2023

5) Precision medicine is increasingly being developed for NSCLC patients with genetic changes, such as BRAF mutations, that can be detected using biomarker tests.(6,7) 5) Precision medicine is increasingly being developed for NSCLC patients with genetic changes, such as BRAF mutations, that can be detected using biomarker tests.(6,7)

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The Pharma Data

NOVEMBER 19, 2020

He focused on corporate and business unit strategies, organizational transformations, product launches, growth strategies and new market entries. Might is director of the Hugh Kaul Precision Medicine Institute and Professor of both Internal Medicine and Computer Science at the University of Alabama at Birmingham.

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Roots Analysis

JANUARY 17, 2024

Contrast Agent Prefilled Syringes: Contrast agents are among the four high-risk groups of medicines, which are used in radiology and can harm the patients. Further, they are useful in clearing blockage and maintain proper delivery of fluids and medications.

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The Pharma Data

MARCH 17, 2021

Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Across clinical trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% had Grade 3 or 4, and 0.4% had fatal outcomes.

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The Pharma Data

MAY 3, 2021

How the FDA’s ‘master plan’ will affect NIH funding for digital medicine projects ( STAT ). Alnylam provides long-term look at Oxlumo, aiming to further carve out stake in PH1 market ( Endpoints ). Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions ( MedtechDive ).

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