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FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

Mucositis, vomiting, nausea, febrile neutropenia, alopecia and reduced appetite among others were reported to be the most prevalent non-laboratory adverse reactions reported. In June 2019, the European Commission granted conditional marketing authorisation for bluebird bio’s Zynteglo to treat transfusion-dependent ?-thalassemia.

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ViiV/J&J’s long-acting HIV regimen finally approved in US

pharmaphorum

It follows a surprise rejection at the end of 2019, due to the information in the dossier related to chemistry, manufacturing and controls (CMC). The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen.

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Lexicomp Drug Information Handbook

RX Note

Adverse Reactions (Significant): Considerations Useful for medication counselling. In early September 2019, the user interface of Lexicomp mobile application is updated. Extensive dosing information Covers dosing in paediatric, older adult and obese patients. Covers dosing in altered kidney function and hepatic impairment too.

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PMPRB takes jurisdiction over medicine (again) following Federal Court of Appeal remand

Pharma in Brief

The PMPRB accepted that there was a slightly elevated incidence of adverse reactions as well as higher efficacy for DIFFERIN XP when compared to DIFFERIN. This case is REASONS FOR DECISION ON REDETERMINATION ORDERED BY THE FEDERAL COURT OF APPEAL ON JUNE 28, 2019.

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Hypertension

RX Note

Resistant Hypertension Resistant hypertension is defined by a patient whose BP is not controlled on three or more drugs (including a diuretic). After excluding medication non-adherence and isolated office hypertension, a quick check on the possible causes of resistant is required.

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Timing of Medication

RX Note

Selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors can cause either activating or sedating adverse reactions. Some adverse reactions can be used as an advantage. 2019 Does it really matter when you take medication?,

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Drugs and Pregnancy

RX Note

Category D - There is positive evidence of human foetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.