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BioWorld - Monday, January 12, 2026
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Regulatory actions for June 9, 2022

June 9, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alimera, Allogene, Astrazeneca, Biocryst, Epimab, Gannex, Harbour, Immunocore, Immunovant, Karyopharm, Novavax, Oryzon, Passage, Regeneron, Roche, Scynexis, Sonoma, Sumitomo, Vertex.
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Other news to note for June 9, 2022

June 9, 2022
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: ABL, Acacia, Aurigene, Biocryst, Coave, Curevac, Curia, Dynamics, Eagle, Exavir, Ferring, Filament, Frame, Horama, Hoth, I-Mab, Integral, Jaguar, Olema, Optimeos, Panavance, Pfizer, Pint, Replicate, Reviral, Seelos, Senti, Tonix, Ziphius .
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In the clinic for June 9, 2022

June 9, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Astrazeneca, Bicycle, Crinetics, DBV, Fibrogen, HMNC, Innovent, Marinus, Medicinova, Moderna, Neurelis, Precision, Prometheus, Promontory, Rigel, Sagimet, Sellas, Talaris, Tevogen.
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Vaccine target

Moderna touts positive results for new COVID-19 booster candidate

June 8, 2022
By Lee Landenberger
Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273.
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Other news to note for June 8, 2022

June 8, 2022
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alvotech, Anavex, Emergent, Imaginab, Implant, J&J, Kadimastem, Lead, Multitude, Neurotrauma, Nosopharm, Oaktree, Oryzon, Oncusp, Oxeltix, Oxurion, Pfizer, Resverlogix, Roche, Stealth, Scisparc, and Targimmune, Tiziana, Vincerx.
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In the clinic for June 8, 2022

June 8, 2022
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, Annexon, Apellis, Concert, Eli Lilly, Engrail, GSK, Kazia, Merck, Moderna, Nascent, Newron, Ridgeback, Seres, Sobi.
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Novavax logo, coronavirus vaccine vials

Novavax COVID-19 vaccine wins adcom support

June 7, 2022
By Mari Serebrov
Given the safety and efficacy data presented June 7 for Novavax Inc.’s COVID-19 vaccine, NVX-CoV2373, it came as no surprise when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee voted 21-0, with one abstention, to support an emergency use authorization for the vaccine, which is already approved and being used in many other countries, including the EU and Canada.
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Regulatory actions for June 7, 2022

June 7, 2022
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 Global Healthcare Conference

Pandemic produced lasting changes in medical device markets

June 6, 2022
By Annette Boyle
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
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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