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CHMP positive opinion recommending approval of Benlysta for adult patients with active lupus nephritis

The Pharma Data

The CHMP’s positive opinion brings us one step closer to providing physicians and patients in Europe with the first treatment option specifically designed to work in lupus and lupus nephritis.”. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis. [3],

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European Commission approves Benlysta for adult patients with active lupus nephritis

The Pharma Data

GlaxoSmithKline plc (GSK) today announced the European Commission has approved the expanded use of intravenous and subcutaneous BENLYSTA (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN) in Europe, in addition to systemic lupus erythematosus (SLE).

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Muscle Imbalances RevealedMuscle Imbalances Revealed

The Pharma Data

What I learned on the DVDs was the missing link when it comes to evaluation and eventual treatment of my clients planning for patients with muscular dysfunctions.”. ll see, and treatment strategies from some top notch names in our industry: Mike Robertson, Bill Hartman, Eric Beard, Rick Kaselj, Kevin Yates, and Dean Somerset.”.

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

1981) (applying Virginia law), both of which involved vaccines. In Stanback the prescriber had a similar practice of not warning of a “slight risk,” which led to the same result: [The prescriber] averred that he had not found it necessary and did not make it his practice to advise patients about the risks associated with flu vaccinations.

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A Texas Mess

Drug & Device Law

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.

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