Remove tag adverse-events
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Grand Rounds June 30, 2023: Decentralized Trials – From Guidance to Reality & What’s Left (Adrian Hernandez, MD, MHS; Pamela Tenaerts, MD, MPH; Craig Lipset, MPH)

Rethinking Clinical Trials

-What is your response to questions surrounding the issue of adverse event reporting issue ? A lot of questions on this topic have to do with the role of the health care provider as it relates to event reporting.

Trials 130
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Grand Rounds May 12, 2023: Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension (Richelle J. Koopman, MD, MS)

Rethinking Clinical Trials

The data visualization started with a basic list of information needed, including systolic and diastolic data; clinic and home data; raw data numbers, effect of medications on blood pressure; goal ranges; out of range values; customizable goal ranges; patient burden of entry; data variability relative to control, and contextual life event data.

Trials 130
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ASH: Argenx cues up a second use for efgartigimod

pharmaphorum

Adverse events such as bruising, headaches, and blood in urine occurred at roughly the same frequency in both groups of patients in ADVANCE IV, and while serious side effects were seen in 8% of the Vyvgart group, that was lower than the 16% reported with placebo.

Sales 52
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Biogen’s Aduhelm rollout goes from bad to worse

pharmaphorum

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug.

Sales 122
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Sarepta’s Elevidys Reaches Finish Line as First Gene Therapy Approved for Duchenne Muscular Dystrophy

XTalks

The therapy’s strong clinical safety data helped Sarepta secure the approval, as among 85 patients, only 13 serious side effects and no deaths or discontinuations due to adverse events were reported. million price tag of Elevidys, a one-time gene therapy. In a media call, Sarepta CEO Douglas Ingram revealed the $3.2

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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

No serious adverse events related to the vaccine candidates studied were reported. The majority of adverse events were mild and transient. Utilizing Clover’s proprietary Trimer-Tag © technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag © Technology.

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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

No serious adverse events related to the vaccine candidates studied were reported. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. The candidate vaccines were given in two doses, three weeks apart.