The Pharma Data

MARCH 26, 2021

The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. The adverse reactions observed in BLISS-LN were consistent with the known safety profile of Benlysta administered intravenously plus standard therapy in patients with SLE. About the BLISS-LN study.

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The Pharma Data

MAY 5, 2021

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).

Therapies 52

Therapies Disease Treatment International 52

Agency IQ

JUNE 7, 2024

The regulations increase focus on post-market requirements and expect continuous and instantaneous updates to all reports and documents when either the product or the benefit-risk ratio changes. Series AIMD 0100 describes all active implantable device types.

Regulations 40

Regulations Compliance Packaging Production 40

The Pharma Data

MAY 13, 2021

Clients who get results will rave about your skills and nothing beats word of mouth marketing. I came across your package through Eric Cressey’s newsletter (I personally completed his Max Strength program and achieved great results) and immediately bought the webinars. Nutritional Therapy Practitioner. Curb Ivanic, MS, CSCS.

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Drug & Device Law

MAY 30, 2022

The plaintiffs’ causation allegations foundered in Himes because the treating physician did not believe that the claimed risks of electroconvulsive therapy were all that big of a deal, and thus did not warn about it. In In re Plavix Marketing, Sales Practices & Products Liability Litigation , 2017 WL 4838842 at *6-7 (D.N.J.

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