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Why There's No Such Thing as a 'Safe' Drug?

Contrarian Sales Techniques

A point of view from a Medical Sales Rep I strongly believe that the most effective insurance policy is not to get sick. During my pharmacology class, I learned that there are no safe drugs, only safe patients. This is before a drug can be approved for public use.

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Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Legacy MEDSearch

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical.

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Pennsylvania-based Highmark Inc. Joins Theranica’s Coverage with Evidence Program for Nerivio® Drug-Free Migraine Treatment Device

Legacy MEDSearch

Under the new program, Highmark members prescribed by providers participating in the program will receive access to Nerivio ®, the first FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals aged 12 and older. Press Release by: Theranica.

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Q32 Bio and Horizon partner to develop autoimmune disease treatment

Pharmaceutical Technology

Q32 will also receive tiered royalty payments on net sales. Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. A fully human anti-IL-7R?

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Pfizer files blockbuster hope etrasimod for ulcerative colitis

pharmaphorum

The FDA and EMA have formally started their review of the drug, which analysts have suggested could become a $3 billion blockbuster for Pfizer if it reaches the market for UC and other immuno-inflammatory diseases. “We believe that etrasimod, if approved, has the potential to be a best-in-class, first-line advanced therapy.”

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Madrigal sees road to approval for NASH drug resmetirom

pharmaphorum

That’s impressive, as it has proved exceedingly difficult for pharmacological therapies to show an impact on fibrosis in prior studies. Similarly, a one-stage or greater improvement in liver fibrosis was seen in 24% and 26% of the resmetirom groups, respectively, versus 14% of patients taking placebo.

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Why aren’t digital pills taking off?

Pharmaceutical Technology

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. But the pharmacology to quantify adherence also depends on race, gender, weight, and other factors.