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BioWorld - Wednesday, March 3, 2021
Home » Topics » Coronavirus, BioWorld Asia

Coronavirus, BioWorld Asia
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Free access to BioWorld coronavirus articles

March 2, 2021
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The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak. Note that we have added three critical tables which are constantly updated:

Vaccines and therapeutics in development

Diagnostics with U.S. FDA emergency use authorization

Clinical trials of biopharma products affected by COVID-19


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Pill bottle with flag of India

India’s pharma industry reevaluating reliance on China APIs

March 2, 2021
By T.V. Padma
No Comments
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.
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Coronavirus vaccine/therapeutics illustration

China pushes on with vaccine efforts, with 16 candidates approved for trials

Feb. 23, 2021
By David Ho
No Comments
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.
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Australia and coronavirus syringe

Australia’s TGA grants provisional approval to Astrazeneca’s COVID-19 vaccine

Feb. 16, 2021
By Tamra Sami
No Comments
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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Antibodies attacking SARS-CoV-2 virus

Chugai adds to evidence for Actemra’s role in COVID-19 treatment line-up

Feb. 16, 2021
By Gina Lee
No Comments
HONG KONG – A Japanese phase III study of Chugai Pharmaceutical Co. Ltd.’s interleukin-6 inhibitor Actemra (tocilizumab) in patients hospitalized with severe COVID-19 pneumonia has read out, expanding what’s known about the drug’s use in the pandemic, which had been inconclusive until recently, though is now known to reduce mortality in the vulnerable population.
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Celltrion-Regkirona-2-9

Celltrion wins first conditional Korean approval for COVID-19 antibody Regkirona

Feb. 9, 2021
By Gina Lee
No Comments
HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld.
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Scientist injecting vaccine into Earth

Comirnaty wins the vaccine approval race in Hong Kong, ahead of leading rivals

Jan. 26, 2021
By David Ho and Gina Lee
No Comments
HONG KONG – Shortly after Australia’s recent provisional approval for the mRNA-based COVID-19 vaccine Comirnaty (tozinameran), originally developed by Pfizer Inc. and Biontech SE, Hong Kong has approved it, too, for emergency use ahead of rivals developed in mainland China. It is the first vaccine to be approved in the Chinese territory, made possible through a collaboration between Biontech and Shanghai Fosun Pharmaceutical Group Co. Ltd.
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Cyclopharm-Technegas-pic-1-26

Australia’s Cyclopharm raises AU$30M ahead of U.S. launch of Technegas for pulmonary embolism

Jan. 26, 2021
By Tamra Sami
No Comments
PERTH, Australia – Sydney-based Cyclopharm Ltd. raised AU$30 million (US$23.19 million) in a private placement that will enable the company to launch its Technegas combination product in the U.S.
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Australia map, flag

Stakeholder survey: Drug and device companies laud TGA’s pandemic response but want process improvements

Jan. 19, 2021
By Tamra Sami
No Comments
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
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COVID-19 vaccine vials

India’s speedy approval of domestic COVID-19 vaccine raises concerns

Jan. 5, 2021
By David Ho
No Comments
HONG KONG – India’s conditional approval on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. but still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to the product, Covaxin, along with the Astrazeneca plc and Oxford University vaccine Covishield. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve it has created controversy and confusion.
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