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BioWorld - Wednesday, May 27, 2026
Home » Topics » Infection » Coronavirus

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Green approved stamp

Pfizer vaccine receives provisional approval in Australia

Jan. 25, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
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Coronavirus mutation illustration

New COVID-19 variants challenging vaccine makers amid rollout

Jan. 25, 2021
By Nuala Moran
LONDON – There is “a realistic possibility” that infection with the B 1.1.7 variant of SARS-CoV-2 is associated with a 30% to 40% increased risk of death compared to earlier variants of the virus, according to scientists on the U.K. government’s New and Emerging Respiratory Virus Threats Advisory Group. That conclusion is based on studies by three university groups, linking community PCR testing to mortality.
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COVID-19 vaccine trial halted

Double blow in COVID-19 fight as Merck terminates two vaccine programs

Jan. 25, 2021
By Cormac Sheridan
Merck & Co. Inc. dropped a bombshell Jan. 25, announcing that it was terminating its two COVID-19 vaccine programs, V-590 and V-591, because neither demonstrated convincing levels of efficacy in phase I trials. As a relatively late entrant to the COVID-19 vaccine race, Merck, of Kenilworth, N.J., was never a leading contender in the effort to bring safe and efficacious vaccines to market. Even so, the failure of these programs is a significant setback, given the company’s scale and experience as a global vaccine manufacturer.
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Regulatory actions for Jan. 25, 2021

Jan. 25, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Albireo, Arrowhead, Astrazeneca, Aurinia, Beigene, EMD Serono, Eusa, Iterum, Junshi, Pfizer, Waymade.
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Other news to note for Jan. 25, 2021

Jan. 25, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AB, Acer, Achilles, Atyr, Biovaxys, Elasmogen, Emergent, Evozyne, GB, Humanigen, Novavax, Nyrada, Ose, Pharmadrug, Piramal, Quercis, Relief, Sairiyo, Samsung Bioepis, Saniona, Seneca, Sonnet, Takeda, Therapeutic Solutions, Theratechnologies, Valneva.
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In the clinic for Jan. 25, 2021

Jan. 25, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Antios, Astrazeneca, Durect, Dynavax, Exelixis, Genentech, Macrogenics, Medigen, Synairgen, Zydus.
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Regulatory front

First Circuit upholds fraud conviction

Jan. 25, 2021
By Mari Serebrov
The latest global regulatory news, changes and updates affecting biopharma, including: And now the state cases; Advamed urges administration to communicate on DPA; Looking for GCP volunteers.
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Regulatory front for Jan. 22, 2021

Jan. 22, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed urges administration to communicate on DPA; FDA posts third-party report for Q1, FY 2021.
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Regulatory actions for Jan. 22, 2021

Jan. 22, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Fluidigm.
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Other news to note for Jan. 22, 2021

Jan. 22, 2021
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alung Technologies, Calcula, Conformis, Elekta, Exagen, Crescita, Orthopediatrics, Ready, Sartorius, Sites Medical, Stedim Biotech, Viewray, Worldwide Clinical Trials.
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