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Novartis builds radio-oncology pipeline with iTheranostics deal

pharmaphorum

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . Novartis licenses the drug from Genmab and reformulated into its Sensoready autoinjector pen. In 2018 it paid $2.1

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Magnus Medical’s SAINT Neuromodulation System Gets FDA Clearance to Treat MDD

XTalks

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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Considerations for Mobile Health Technology Developers: Part 2

pharmaphorum

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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Novartis expands in radio-oncology again with $1.3bn Artios alliance

pharmaphorum

In its second licensing deal in the radio-oncology area in consecutive weeks, Novartis has agreed a $1.3 Novartis has made radioligands one of four pillars of its cancer business, along with cell and gene therapy, targeted drugs and immunotherapeutics, and has been steadily bolting on assets to expand its pipeline in this area.

DNA 52
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Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

A cross-check ensures curriculum vitae (CVs), and medical licenses (if appropriate) are on file and current. For example, most hospital radiology technicians are trained to perform scans for the hospital and/or PI for clinical trials based on the information in the test requisitions. Form FDA 1572 The Form FDA 1572 is unique to U.S.

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FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

The Pharma Data

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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Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer

The Pharma Data

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.