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BioWorld - Wednesday, July 6, 2022
Home » Topics » Infection » Coronavirus

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Regulatory actions for June 7, 2022

June 7, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Amgen, Antengene, Aum, Biocryst, Biondvax, BMS, Clarity, Cstone, Enlivex, GBT, Iaso, Innovent, Lexaria, Pfizer, Revive, Senhwa, Sensorion, Sifi, Veru.
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RBC panel:

Pandemic produced lasting changes in medical device markets

June 6, 2022
By Annette Boyle
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Even as new waves of COVID-19 cause less direct disruption in the delivery of health care, the ongoing pandemic leaves a dramatically altered landscape for medical devices in its wake. The RBC Global Healthcare Conference revealed trends that will continue to reshape the utilization of medical technology and delivery of health care, while industry leaders drilled down into the details in a focused panel discussion. All agreed: the pandemic catapulted telemedicine and remote monitoring ahead five or more years, a hybrid delivery system with greater fluctuations in volume will emerge, devices that facilitate the movement of care out of the hospital to home or outpatient settings will remain in high demand and patient-centered control of health care will continue to attract additional industries into health care markets.
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In the clinic for June 6, 2022

June 6, 2022
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Affibody, Alx, Aurinia, Biogen, Biothera, Incannex, Inmagene, Intercept, Merck, Nicox, Novo Nordisk, Olix, Sorrento, Tranquis.
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Microscope and coronavirus illustration

As world hobbles away from COVID-19, research forges on

June 3, 2022
By Karen Carey
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Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century. Now, into its third year, those at-risk have numerous options and growing numbers of people have achieved immunity through vaccines and infection.
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FDA reviewers raise myocarditis concerns ahead of Novavax adcom

June 3, 2022
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Shares of Novavax Inc. dropped 19% after briefing documents released ahead of the U.S. FDA’s June 7 advisory committee raised concerns about risks of myocarditis associated with COVID-19 vaccine NVX-CoV2373, though reviewers also noted the vaccine could offer protection against the omicron variant. The stock (NASDAQ:NVAX) closed June 3 at $44.76, down $11.21.
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Other news to note for June 3, 2022

June 3, 2022
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alnylam, Ampio, Astrazeneca, Athersys, Biovaxys, Boehringer Ingelheim, Etirarx, Gilead, Hookipa, Immunocore, Innate, Nirvana, Pfizer, Resilience, Sanofi, Vaxart.
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In the clinic for June 3, 2022

June 3, 2022
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Alterity, Anji, Apnimed, Axsome, BMS, Braxia, Centessa, Dyve, Immunic, Megakaryon, Neuvivo, NLS, Onkure, Sapience, Vaxart, Vectivbio.
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Microscope and coronavirus illustration

As world hobbles away from COVID-19, research forges on

June 2, 2022
By Karen Carey
No Comments
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century.
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Other news to note for June 2, 2022

June 2, 2022
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4P, Atreca, BMS, Caris, Centessa, Checkmate, Delta 4, ICER, Immatics, Kuros, Manhattan, Merck & Co., Moderna, Regeneron, Renovacor, Proxygen, Sanofi, Sorrento, Vectory, Xoma and Zosano.
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In the clinic for June 2, 2022

June 2, 2022
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABVC, Active, Adamis, Amolyt, Axsome, Baudax, Biogen, Celltrion, Cincor, Corium, Diurnal, Gamida, Horizon, Indivior, Janssen, Mitsubishi, Neurosense, Realta, Relief, Sage, Samsung, Syndevrx, Taurx, Trethera, Zynerba.
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