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Home » Topics » Regulatory » WHO

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Virus and drug illustration

WHO pushes for more access to COVID-19 drugs

April 12, 2023
By Mari Serebrov
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the WHO is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions. 
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Virus and drug illustration

WHO pushes for more access to COVID-19 drugs

April 11, 2023
By Mari Serebrov
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the World Health Organization (WHO) is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions so the treatments can be used where they’re needed most.
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India drug regulations under the scanner again after fresh WHO alert on contaminated cough syrup

Jan. 31, 2023
By T.V. Padma
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country.
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India drug regulations under the scanner again after fresh WHO alert on contaminated cough syrup

Jan. 20, 2023
By T.V. Padma
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country, varieties of which have led to the deaths of scores of children in late 2022.
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WHO pulls COVID-19 recommendations from GSK-Vir, Regeneron MAbs

Sep. 16, 2022
By Lee Landenberger
What was once effective is now a non-starter. Newly updated guidelines from the World Health Organization (WHO) caution against using the COVID-19 treatments sotrovimab, from GSK plc and Vir Biotechnology Inc., and Regen-Cov (casirivimab + imdevimab), from Regeneron Pharmaceuticals Inc. Omicron, the group said, has rendered the monoclonal antibodies ineffective.
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Russia’s Gamaleya charts its own path for next-gen COVID-19 vaccine

Aug. 23, 2022
By Mari Serebrov
While other COVID-19 vaccine makers are developing bivalent boosters comprising the original SARS-CoV-2 strain and an omicron variant, Russia’s Gamaleya National Research Center of Epidemiology and Microbiology is trekking a different course. Leaving behind the ancestral strain, Gamaleya’s next generation of the Sputnik V vaccine has been specifically adapted against delta and omicron variants of the coronavirus.
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Ebola virus

Ebola losing ‘killer’ status to MAbs

Aug. 22, 2022
By Mari Serebrov
Regeneron Pharmaceuticals Inc.’s Inmazeb and Ridgeback Biotherapeutics LP’s Ebanga earned a ringing endorsement from the World Health Organization (WHO) in its first ever guideline on Ebola therapies. In releasing the guideline Aug. 19, WHO officials celebrated the fact that Ebola is no longer “a near certain killer” – provided treatment starts as soon as possible following diagnosis.
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FDA vaccine illustration

US guidance on next-gen boosters a new era in COVID-19

July 1, 2022
By Mari Serebrov
The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
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Novavax-COVID-19-vaccine-vial

Novavax vaccine shows its chops

June 29, 2022
By Mari Serebrov
Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead being played by the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE. But the data presented at the June 28 Vaccines and Related Biologic Products Advisory Committee meeting suggest the Novavax adjuvanted protein vaccine may have the chops to take on a larger role in taming the pandemic.
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CDC: No ‘may’ about it when it comes to COVID-19 pediatric vaccines

June 20, 2022
By Mari Serebrov
Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for babies, toddlers and preschoolers.
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