The Pharma Data

MAY 5, 2021

Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy. [1]. Immunisation: Do not give live vaccines 30 days before, or concurrently with Benlysta.

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Therapies Disease Treatment International 52

Drug Target Review

NOVEMBER 30, 2023

Then I was approached to co-found AC Immune in 2003. Food and Drug Administration for our Alzheimer’s vaccine candidate, ACI-24.060. We are the only company in the world including this population in any Alzheimer’s drug trial, and we are very proud of this! COVID-19 has shown the revolutionary impact of vaccines.

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Disease Laboratories Therapies Treatment 95

Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. While the SRP could be used to submit information on drugs and biological products, the only exception was for vaccines.

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The Pharma Data

FEBRUARY 25, 2021

FDA ACCEPTS FOR PRIORITY REVIEW PFIZER’S APPLICATION FOR TICOVAC (TICK-BORNE ENCEPHALITIS VACCINE). If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations. 1,2 If approved, TicoVac would be the first vaccine in the U.S.

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FDA Vaccine Virus Clinical Trials 52

The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

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Drug & Device Law

MARCH 4, 2024

A Vaccine Act case similarly held that “parties are expected to put their best case forward in the first instance.” March 14, 2003), recognized that replacing an excluded expert “is not the way the Federal Rules of Civil Procedure work. and (2) suggesting that the Defendants can cross-examine [the expert] about this at trial.

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Testimonials Production Vaccine Pharmaceuticals 52

Drug & Device Law

FEBRUARY 20, 2023

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

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FDA FDA Approval Testimonials Vaccine 59