Scienmag

JANUARY 14, 2021

Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) AdvaMed, the American Academy of Pediatrics (AAP) and multiple pediatric health system leaders, is […]. Multi-stakeholder event will focus on national innovation ecosystem for pediatric medical device development TUCSON, Ariz.,

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FDA Law Blog

NOVEMBER 5, 2023

Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices.

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The Pharma Data

FEBRUARY 21, 2022

We are taking bold steps into the future of drug development, investing strongly in areas at the forefront of the biomedical and technological revolution. Re-imagining Radiology. In particular, AI bears vast potential for advancing radiology.

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Camargo

OCTOBER 8, 2020

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. Camargo also contributed its expertise in the 505(b)(2) pathway as well as orphan drug, fast-track, breakthrough, and priority review designations to advance and accelerate the product to approval. The Solutions. Commercial.

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Drug Discovery World

FEBRUARY 20, 2024

The contract was awarded by the Defense Threat Reduction Agency’s (DTRA) Joint Science and Technology Office (JSTO) for the Chemical and Biological Defense (CBD) Program, through the Medical Chemical, Biological, Radiological, and Nuclear (CBRN) Defense Consortium (MCDC) requirement 22-05, ‘Adjuvant Activity to Vaccines Prototype’.

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pharmaphorum

MAY 18, 2022

” He was also involved in the creation of the FDA’s Digital Health Center of Excellence in 2020 and drawing up the Center for Devices and Radiological Health (CDRH) 2022-2025 strategic priorities, which covers much of the agency’s digital health plans.

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Delveinsight

DECEMBER 29, 2020

However, for geographies other than the US and Canada, Pfizer has received an exclusive right to develop the drug in oncology except in certain Asian countries. Welcome the First Generic of Drug for Severe Hypoglycemia. mg and norethindrone acetate (0.5 mg) in the US and Canada. Audentes Therapeutics’ ASPIRO Trial Free to Proceed.

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pharmaphorum

JUNE 13, 2022

It aimed to make genomics part of routine healthcare in the NHS, create a genomics data resource and stimulate partnerships with biopharma companies on drug discovery projects, and is still generating new findings for participants. ” The post Genomics England will move HQ to Canary Wharf’s new biocluster appeared first on.

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Drug Discovery World

JULY 24, 2023

Even with standardised methods, it typically takes months to achieve the first useful production of a biological drug. The post Ginkgo Bioworks awarded DARPA contract for therapeutic proteins appeared first on Drug Discovery World (DDW).

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Protein Manufacturing Gene Sequencing Production 52

XTalks

MARCH 27, 2023

Cidara Therapeutics and Melinta Therapeutics recently announced that Rezzayo (rezafungin for injection) has been approved by the US Food and Drug Administration (FDA). Echinocandins offer a number of advantages to other antifungal medications including fewer drug-drug interactions, unique mechanism of action and fewer AEs.

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XTalks

JANUARY 26, 2024

Overcoming drug resistance: A major challenge in cancer treatment is the development of resistance to chemotherapy drugs. CRISPR/Cas9 offers a pathway to potentially overcome this, by modifying genes that are responsible for drug resistance in cancer cells.

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The Pharma Data

DECEMBER 15, 2020

Food and Drug Administration. director of the FDA Center for Devices and Radiological Health, “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. TUESDAY, Dec. Results are delivered by smartphone in as little as 20 minutes. According to Jeffrey Shuren, M.D.,

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FDA Approval Radiology Protein Drugs 52

Worldwide Clinical Trials

MAY 24, 2022

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. Every patient is precious on these studies.

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The Pharma Data

SEPTEMBER 30, 2021

Food and Drug Administration authorized marketing of software to help medical professionals who examine body tissues (pathologists) within the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue faraway from the body). Today, the U.S.

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XTalks

SEPTEMBER 9, 2022

This week, Magnus Medical’s SAINT Neuromodulation System received 510(k) clearance from the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults who did not have satisfactory improvement from past antidepressant medications in their current episode.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration on Wednesday. “This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in an agency news release.

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Packaging Packaging Radiology Drugs 52

The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF). SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. ,

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XTalks

JUNE 30, 2023

Bayer, a renowned German pharmaceutical company, has recently announced that its Ultravist 300 and 370 (iopromide) injection has won approval from the US Food and Drug Administration (FDA) for use in contrast-enhanced mammography (CEM).

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XTalks

APRIL 19, 2024

Avicenna.AI , a leading medical imaging AI company, has received US Food and Drug Administration (FDA) 510(k) clearance for two of its AI-based tools, CINA-iPE and CINA-ASPECTS, which are designed to enhance the diagnosis and assessment of pulmonary embolism and stroke severity, respectively, via CT scans.

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The Pharma Data

OCTOBER 1, 2021

Dr. Olaf Weber, Head of Radiology Research and Development at Bayer. there have been three patients (1.9%) with drug-related TEAEs – one on gadobutrol (paresthesia) and two on gadoterate (pruritus, urticaria). About Radiology at Bayer Everyone deserves clear answers about their health, starting with an early and accurate diagnosis.

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Drug Discovery World

OCTOBER 2, 2023

These advances are seen in many indications of imaging as it relates to drug trials – oncological, cardiovascular, metabolic, NASH, musculoskeletal and other. European Journal of Radiology 105 (2018) 246–250 [4] Jiang, et al. Integrating artificial intelligence into the clinical practice of radiology: challenges and recommendations.

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Clinical Trials Clinical Trials Trials Radiology 59

The Pharma Data

MARCH 24, 2021

The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks. These results have been presented to the independent Data Safety Monitoring Board. JPEO-CBRND.

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FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

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pharmaphorum

SEPTEMBER 30, 2022

The results have been billed as a clear win, with a reduction in cognitive decline accompanying the clearance of amyloid plaques that characterise the disease – which could be a first for an amyloid-targeting drug – and across-the-board improvements in primary and secondary endpoints. In Clarity AD, the rate of ARIA-E was 12.5% “A 0.45

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Drug Discovery World

APRIL 8, 2024

Following this, Benjamin Cravatt, Professor and the Norton Gilula Chair in Biology and Chemistry at The Scripps Research Institute, discussed activity-based protein profiling (ABPP) and its use in discovering drug candidates for cancer-relevant proteins.

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The Pharma Data

APRIL 15, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. director of the FDA’s Center for Devices and Radiological Health. Today, the U.S. for the next public health emergency.”.

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The Pharma Data

MARCH 22, 2021

We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization.”. The Phase III D8110C00001 trial is part of this funding agreement. JPEO-CBRND.

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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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XTalks

OCTOBER 26, 2022

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has moved forward with a plan to minimize the risks of breakthrough medical devices by introducing its voluntary Total Product Life Cycle Advisory Program (TAP) Pilot.

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Roots Analysis

MAY 3, 2022

You may also be interested in the following titles: AI-based Drug Discovery Market (2nd Edition) CAR-T Cell Therapies: Intellectual Property Landscape Plant-based Meats: Intellectual Property Landscape. For more details on this emerging domain, check out the following report : Teleradiology Services Market – Roots Analysis.

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Marketing Radiology Drugs 52

XTalks

DECEMBER 14, 2023

The US Food and Drug Administration (FDA) is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics’ DreamStation 2 CPAP machines used to treat or manage obstructive sleep apnea.

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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. There are many different causes of epileptic spasms.

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FDA Law Blog

JUNE 28, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions.

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FDA Law Blog

NOVEMBER 21, 2022

Food & Drug Admin., Food & Drug Admin., here ), Federal Register notice ( here ) and the Program Website ( here )). The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. 11, 2022) [hereinafter “ Announcement ”].

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Drug Discovery World

OCTOBER 24, 2022

The approach combines traditional chemotherapy drugs with a new method for irradiating the tumour. We think the constant radiation allows the drugs to interact with its effects more strongly than external beam therapy allows,” Schaal added.

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pharmaphorum

MARCH 31, 2021

Novartis has been steadily building itself into a radio-oncology powerhouse in the last few years, seeing the category as one of four pillars of its cancer business, along with cell and gene therapy, targeted drugs and immunotherapeutics. Novartis licenses the drug from Genmab and reformulated into its Sensoready autoinjector pen.

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The Pharma Data

NOVEMBER 9, 2021

million fresh courses of molnupiravir, an investigational oral antiviral drug, if the drug is granted Exigency Use Authorization (EUA) or blessing by theU.S. Food and Drug Administration (FDA), for roughly$ 1 billion. With these exercised options, theU.S. government has now committed to buy a aggregate of roughly3.1

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