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STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. ” said Ameet Sarpatwari, the assistant director of the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital.

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Opinion: Health care coaches are the next big thing. They’re also completely unregulated

STAT

It turns out that one of the supplements recommended by the health coach has adverse reactions with a medication prescribed by his doctor. He goes to the emergency room, where they immediately ask him about medications and supplements he’s taking. The health coach never asked John about his medications. Read the rest…

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

The most common adverse reactions seen in a trial cohort of 38,000 patients were at injection sites (84.1%) followed by fatigue (62.9%) and headache (55.1%), and serious adverse reactions occurred in 0% to 4.6% of participants.

Vaccines 111
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NICE says yes to BeiGene’s Brukinsa after Scottish nay

pharmaphorum

.” The document notes however that there is a high unmet need for an effective and well tolerated treatment for WM “where current chemoimmunotherapy options can cause severe adverse reactions and the need for frequent hospital visits.”

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Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19

PharmaShots

those on dialysis The positive opinion was based on the results from a P-I PK study (GS-US-540-9015) as well as results from the P-III trial (REDPINE) evaluating the safety of Veklury in a ratio (2:1) in 243 hospitalized adult patients hospitalized with COVID-19 with sev. renal impairment, incl. renal impairment.

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Fresenius Kabi introduces Vasopressin Injection, USP, in US

Pharma Leaders

Fresenius has invested nearly $1bn for the manufacture as well as distribution of Vasopressin to serve hospitals and health systems in the US. Bradycardia, tachyarrhythmias, decreased cardiac output, ischemia, and hyponatremia are some of the adverse reactions on using Vasopressin.

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Fresenius Kabi introduces Vasopressin Injection, USP, in US

Pharmaceutical Business Review

Fresenius has invested nearly $1bn for the manufacture as well as distribution of Vasopressin to serve hospitals and health systems in the US. Bradycardia, tachyarrhythmias, decreased cardiac output, ischemia, and hyponatremia are some of the adverse reactions on using Vasopressin.