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Home » Topics » Infection » Coronavirus

Coronavirus
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Regulatory actions for May 25, 2021

May 25, 2021
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Amg International, Choicespine, Guard Medical, Ihealthscreen, Jenavalve, Quidel, Unity HA, Uroviu.
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Other news to note for May 25, 2021

May 25, 2021
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adventhealth, Alpha Imaging, Anpac Bio-Medical Science, Burstiq, Confluent Medical Technologies, Drawbridge Health, F-Star Therapeutics, GT Medical Technologies, Henry Schein, Inivata, Isoplexis, Jarvis Analytics, Ka Imaging, Lifebit Biotech, Mount Sinai Genomics, Nexstim, Novocure, Paige, Promis Neurosciences, Quest Diagnostics, Rulestar, Thorne Healthtech, Waters.
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Approved stamp

As regulatory activity climbs over last year, the focus on COVID-19 declines

May 25, 2021
By Karen Carey
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Global regulatory activity in 2021 has risen by 25% over this time last year, but the proportion of the activity associated with COVID-19 has dropped in recent months.
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Moderna COVID-19 vaccine

Moderna’s COVID-19 vaccine is 100% effective in adolescents

May 25, 2021
By Lee Landenberger
No Comments
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
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Regulatory actions for May 25, 2021

May 25, 2021
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Ascletis, Asklepios, Idorsia, Janssen, Optimus, Pharmather, Provention, Sandoz, Scholar Rock, TG, Therapeuticsmd, TLC.
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Other news to note for May 25, 2021

May 25, 2021
No Comments
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acurastem, Alloy, Antion, Astrazeneca, Bioventus, BMS, Clarus, Defence, Expansion, Gigagen, Havah, Merck, Nevakar, Pyxis, Scripps Research, Silence, Vyluma, Xencor, Xilio, Zelluna.
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In the clinic for May 25, 2021

May 25, 2021
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Eyenovia, Flugen, Incyte, Innovent, Moderna, Moleculin, Nordic Nanovector, Oncopeptides, RDIF, Sobi, Tavanta, Telix, Tiziana.
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Three co-founders in the lab

Biosynex acquires Avalun to become European leader in rapid diagnostic testing

May 24, 2021
By Bernard Banga
No Comments
PARIS – Biosynex SA signed a binding offer to acquire 100% of the stock in Avalun SAS, a company developing the Labpad in vitro diagnostic device that provides rapid biological test results from small sample volumes. In Europe, Avalun is currently marketing a follow-up test for patients on anticoagulation therapy using antivitamin K agents, and a test for automated antigen detection for COVID-19.
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Global vaccine illustration

Mixed signals? Or a third way on COVID-19-related IP waivers?

May 24, 2021
By Mari Serebrov
No Comments
In seeming opposition to U.S. Trade Representative Katherine Tai’s support of a proposed compulsory World Trade Organization intellectual property (IP) waiver on COVID-19-related medical products, U.S. Vice President Kamala Harris signed onto the G20’s May 21 Rome Declaration that commits the member countries to work to defeat the pandemic within the current flexibilities of the TRIPS agreement by promoting voluntary IP licensing agreements, technology and knowledge transfers, and patent pooling on mutually agreed terms.
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U.S. bond program proposed to spur R&D for unmet medical needs

May 24, 2021
By Mari Serebrov
No Comments
With the intense focus on developing COVID-19 diagnostics, sequencing tools, vaccines and treatments, the pandemic is having an outsized impact on the global development of drugs and devices to treat other diseases. Recent data show that more than 1,000 clinical trials worldwide remain disrupted by COVID-19, including 60% of the non-COVID-19 trials being conducted in the U.S., as funding and other resources continue to be directed toward ending the pandemic.
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