The Pharma Data

JULY 22, 2021

Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Biogen Inc.

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Disease Research Clinical Trials FDA 52

The Pharma Data

MAY 5, 2021

The EU marketing authorisation follows the recent approval for the similar expanded LN indication in the U.S. pneumonia and sepsis) occurred more frequently in patients receiving Benlysta; consider pneumococcal vaccination prior to initiation. 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

On my return to Europe, I took a position at Nestlé as Head of the Research Centre, where I led the scientific development of several highly innovative health promoting food products from laboratory to market. Then I was approached to co-found AC Immune in 2003. COVID-19 has shown the revolutionary impact of vaccines.

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Disease Laboratories Therapies Treatment 95

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 40

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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Virus Trials Disease Hospitals 40

Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & 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.

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Testimonials Production Vaccine Pharmaceuticals 52