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

The Pharma Data

The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. 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.”.

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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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Alzheimer’s disease community from our Head of Research and Development, Alfred Sandrock, M.D., Ph.D.

The Pharma Data

NOTE: ADUHELM TM (aducanumab-avwa)injection 100 mg/mL solutionis indicated for the treatment of Alzheimer’s disease. 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. Biogen Inc.

Disease 52
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Women in Stem with Andrea Pfeifer

Drug Target Review

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.

Disease 95
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U.S. FDA ACCEPTS FOR PRIORITY REVIEW

The Pharma Data

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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Alex Gorsky to Serve as Executive Chairman and Transition Role.

The Pharma Data

Gorsky’s leadership has been oncology, with the Company’s sales in this area growing from approximately $2 billion in 2011 to over $12 billion in 2020, while acquisitions have included Actelion, the largest in the Company’s history, which significantly expanded Johnson & Johnson’s Pharmaceutical segment portfolio of rare-disease treatments.

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Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial

The Pharma Data

In contrast to other options for RSV under development, such as maternal vaccines, nirsevimab was designed to be administered at birth to infants born during the RSV season or at the season’s start for infants born prior to the season. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering.

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