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why is lupin limited (500257) falling ✌️【Asset】✌️ Real-time global stock trend and futures data to help you plan investment strategies for long-term returns. The pediatric formulation of dolutegravir, a drug recommended as first-line HIV treatment by the World Health Organization, will come as a strawberry-flavored tablet that can be dissolved in water or juice, making it easier to give to children too young to swallow tablets.
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On World AIDS Day Tuesday, Unitaid and Clinton Health Access Initiative released astatementabout the drug and announced a pricing agreement to make it available in low- and middle-income countries.
“The 10 mg scored dispersible tablet was developed by Viatris (Mylan) and Macleods based on the technical information provided by ViiV Healthcare,” Clinton Health Access Initiative spokeswoman Regan Lachapelle said in an email.
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In low- and middle-income countries, the pediatric formulation of dolutegravir will cost about $36 per child per year, based on the pricing agreement brokered by Unitaid and Clinton Health Access Initiative with generic manufacturers Viatris and Macleods.
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“If infants get treated and their virus stays suppressed or controlled, they can live into their 3rd, 4th or perhaps even 5th decade of life—or longer,” Dr. Deborah Persaud, a professor of pediatrics at Johns Hopkins University and an expert in HIV/AIDS in children, told 【 - Free Real-Time Market Predictions 】.
“Even if they are on treatment, for many years they have been on suboptimal drugs, because it always takes longer to develop and approve medications for children compared to adults,” Dr. Martina Penazzato, the HIV lead at the World Health Organization, told 【 - Free Real-Time Market Predictions 】.
Penazzato said the formulation of pediatric dolutegravir could be “quite transformative” in the fight against pediatric HIV.
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ViiV Healthcare’s pediatric dolutegravir received US Food and Drug Administration approval in June, and the generic product received tentative approval on November 19 under the US President’s Emergency Plan for AIDS Relief (PEPFAR).
“This is the first time a generic product has been positively reviewed within several months of the originator product receiving FDA approval, reducing the gap from three years for the adult version of the same medicine to just five months,” Unitaid and Clinton Health Access Initiative wrote.
“FDA tentative approval via the President’s Emergency Plan for AIDS Relief (PEPFAR) program allows procurement of the product by US agencies such as PEPFAR, USAID,” Lachapelle said in an email.
“Each generic company is also in the process of registering the products within the countries where it will be used.”
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