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Off-label Use

RX Note

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

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Late-stage ulcerative colitis pipeline continues to innovate

Pharmaceutical Technology

While the exact cause of UC remains unknown, it is often associated with immune system malfunction. One potential benefit of cobitolimod’s unique route of administration is that local administration via rectal enema has the potential to limit systemic absorption and the immune-related side effects that plague some marketed agents.

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How advanced technology can streamline the COVID-19 vaccine rollout

pharmaphorum

The integration of real-time track and trace technology, handheld mobile smart devices and advanced analytics solutions into the COVID-19 vaccine rollout is our best shot to enhance the global vaccination effort and combat new variants with herd immunity. Critical supply chain visibility. Adverse reactions to the vaccine.

Vaccines 119
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Trial bias concern scuppers Y-mAbs brain cancer drug in FDA vote

pharmaphorum

Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumour cells of several cancer types. “Y-mAbs is committed to working closely with the FDA on their review of…omburtamab ahead of their decision,” he added.

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Are Flame Retardant Toxins Contributing to Your Thyroid Condition?

The Thyroid Pharmacist

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

Breathing in pollutants is inflammatory, and triggers an immune response as the body tries to process out the toxins. Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, But formaldehyde has been labeled as a known human carcinogen by the U.S.

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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.