SK Bioscience Ltd. has won approval from the South Korean Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for its COVID-19 vaccine candidate GBP-510, making the recombinant protein antigen vaccine the first domestically developed candidate to make it to late-stage testing. “We aim to begin the phase III trials within August and to have the data ready by early 2022,” a company spokesman told BioWorld.
PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.
HONG KONG – The Biden administration’s support for a TRIPS waiver of COVID-19 vaccine patents has already met a chorus of resistance from Western companies. In Asia, skepticism about how it would be achieved and what it will cover, is widespread.
HONG KONG – Laboring under the burden of a new wave of COVID-19 infections that have raised its case total to 15.3 million, second only to the U.S., India is ramping up its vaccination efforts by opening up COVID-19 vaccine availability to citizens 18 years or older from May 1, according to the Ministry of Health and Family Welfare. However, ensuring a steady vaccine supply for the world's second most populous country, with nearly 1.4 billion people, might prove to be an issue. So far, India has administered just over 124 million COVID-19 vaccine doses.
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Australian manufacture of Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S), which is being manufactured by CSL Ltd.
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”
NEW DELHI – Significant disruptions to supplies of active pharmaceutical ingredients (APIs) from China caused by the COVID-19 pandemic have led India to fundamentally rethink its supply chains and the structure of its pharmaceutical industry, according to industry executives and consultants.
HONG KONG – China is steadily greenlighting more COVID-19 vaccines and drugs to go deeper into the clinic, giving the country a growing arsenal against the disease. To date, China’s National Medical Products Administration (NMPA) has approved a handful of drugs and 16 domestically developed COVID-19 vaccine candidates for trials, up from 11 in September 2020.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26 provisional approval for Pfizer Australia Pty Ltd.’s COVID-19 vaccine, branded Comirnaty.
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