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Regulatory
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Regulatory actions for March 25, 2022

March 25, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arrowhead, Azafaros, Eli Lilly, Fennec, Fluoguide, Innovent, Pfizer, Viiv.
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Regulatory actions for March 24, 2022

March 24, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fluoguide, Novartis, Tendonova.
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Person using COVID-19 antigen test at home

EUAs for COVID testing still arriving at a rapid pace in third year of pandemic

March 24, 2022
By Mark McCarty
The FDA continues to issue new and revised emergency use authorizations for testing for the COVID-19 pandemic in recent days, including three reissued and four revised EUAs dated March 24.
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Judge's gavel with US flag

Illumina identifies specific trade secret disclosures in lawsuit against Guardant

March 24, 2022
By Mark McCarty
The lawsuit filed by Illumina Inc., against officials with Guardant Health Inc., revolves around trade secrets allegedly misappropriated by two former Illumina employees, including Helmy Eltoukhy, who helped to found Guardant while still employed at Illumina. Among other things, the complaint states that Eltoukhy had asked another Illumina employee about research that ultimately ended up in the hands of Guardant despite that the document in question was explicitly labeled as confidential and for internal use only.
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EU, WHO expand African partnership

March 24, 2022
By Mari Serebrov
Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access.
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Lung cancer illustration

Innovent, Lilly receive CRL for NSCLC candidate sintilimab

March 24, 2022
By Michael Fitzhugh

Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.



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FDA Approved stamp

US FDA approves Novartis’ radioligand therapy and imaging agent for metastatic prostate cancer

March 24, 2022
By Lee Landenberger
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
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Regulatory actions for March 24, 2022

March 24, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Moberg, Morphosys, Novavax, Phanes, Secura, Silence, TC, Xcovery.
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Regulatory actions for March 23, 2022

March 23, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artio Medical, Cerus Endovascular, SIS Medical.
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Green traffic light

FDA gives green light to Artio Medical occlusion device

March 23, 2022
By Catherine Longworth

The FDA cleared a peripheral vascular occlusion product developed by Artio Medical Inc. The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.


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