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STAT+: After a high-profile pressure campaign, Cepheid agrees to sell a TB test at cost

STAT

Each year, 10 million people fall ill with the disease, which is most prevalent in India, Indonesia, China, and Nigeria. million people die from TB each year, making it the world’s top infectious killer, according to the World Health Organization. Despite being preventable and curable, 1.5

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Indonesia bans sale of syrup medicines after at least 99 child deaths

The Guardian - Pharmaceutical Industry

Country investigating 206 cases of kidney injury that could be linked to ingredients in liquid medicines Indonesia has banned the sale of all syrup medicines as it investigates the deaths this year of nearly 100 children, warning that the liquids may contain ingredients linked to fatal kidney injuries.

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How To Effectively Engage With Indonesian Authorities For Medical Device Approval

Pharma Mirror

Indonesia, being the fourth most populous country in the world, presents a significant market opportunity for medical device manufacturers. The Indonesia medical device registration process is a necessary pathway for any foreign manufacturer looking to supply their products in this burgeoning market.

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Takeda gets first approval for its dengue vaccine

pharmaphorum

Japan’s Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product. Qdenga has been approved for use regardless of prior dengue exposure, so can be prescribed without the need for pre-vaccination testing, said Takeda.

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Indonesia grants EUA for US-developed Covid-19 vaccine

Pharmaceutical Technology

Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. Indonesia is pursuing halal certification for IndoVac as its production did not utilise any animal cells or products.

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Novavax gets first authorisation for its COVID-19 jab

pharmaphorum

Novavax has been granted its first emergency use authorisation in Indonesia for COVID-19 vaccine NVX-CoV2373, and expects other regulators in India, the Philippines and other countries to follow suit in the coming weeks. That makes it well suited to distribution in countries where healthcare delivery is more challenging.

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CHMP recommends dengue vaccine for children

European Pharmaceutical Review

“We are one step closer towards the approval of a dengue vaccine that could benefit many of the millions of individuals around the world exposed to dengue. TAK-003 has not yet been approved anywhere else in the world. Data from the World Health Organization (WHO) estimates around 390 million people are infected every year.