Johnson & Johnson single shot coronavirus vaccine approved for use in EU
The Johnson and Johnson vaccine has proven to be effective in providing protection against severe Covid-19
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The Johnson & Johnson jab. (Image: REUTERS)
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The European Medicines Agency have today approved the usage of the Johnson & Johnson single shot coronavirus vaccine in Europe.
IPM’s New Drug Application for Dapivirine Vaginal Ring to Reduce HIV Risk in Women Accepted for Filing by US Food and Drug Administration
IPM’s New Drug Application for Dapivirine Vaginal Ring to Reduce HIV Risk in Women Accepted for Filing by US Food and Drug Administration
SILVER SPRING, Md. (March 3, 2021) The nonprofit International Partnership for Microbicides (IPM) announced today that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for the monthly dapivirine vaginal ring, designed to reduce the risk of HIV-1 infection through vaginal sex.
Made of flexible silicone, the investigational product releases an antiretroviral drug (ARV) called dapivirine over the course of one month. Women can insert and replace the ring themselves. IPM designed the ring to offer women a discreet and long-acting HIV prevention choice that they can control themselves.
Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results
Diluted EPS of $1.23; Non-GAAP Diluted EPS of $2.19 – Full Year 2020 Year-Over-Year: – Product Sales increased 10% to $24.4 billion, primarily due to Veklury – – Diluted EPS of $0.10; Non-GAAP Diluted EPS of $7.09 – – Returned $5.0 billion of cash to shareholders through dividends and share repurchases – Full Year 2021 Guidance: – Product Sales including Veklury of $23.7 billion to $25.1 billion – – Operating …
– Diluted EPS of $1.23; Non-GAAP Diluted EPS of $2.19 – Full Year 2020 Year-Over-Year: – Diluted EPS of $0.10; Non-GAAP Diluted EPS of $7.09 – – Returned $5.0 billion of cash to shareholders through dividends and share repurchases – Full Year 2021 Guidance: – Operating expenses flat to low single-digit percentage decline – – Non-GAAP Diluted EPS of $6.75 to $7.45 –
IPM Welcomes WHO’s Recommendation for Dapivirine Vaginal Ring as New Women’s HIV Prevention Option
IPM Welcomes WHO’s Recommendation for Dapivirine Vaginal Ring as New Women’s HIV Prevention Option
WHO recommends the monthly ring be offered as part of a combination prevention approach for women at substantial HIV risk
SILVER SPRING, Md. (January 27, 2021) The nonprofit International Partnership for Microbicides (IPM) welcomes today’s recommendation by the World Health Organization (WHO) that the monthly dapivirine ring may be offered as an additional prevention choice for women at substantial risk of HIV infection. The WHO’s recommendation supports expanding the prevention portfolio with the first long-acting option that a woman could control herself and use discreetly to reduce her HIV risk during vaginal sex, pending regulatory approvals for the product.
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TITUSVILLE, N.J., Jan. 21, 2021 /PRNewswire/ The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen s rilpivirine and ViiV Healthcare s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen s 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resist