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Approvals for Novartis, Incyte; designations for Avadel, Iovance

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Approvals for Novartis, Incyte; designations for Avadel, Iovance

Approvals and designations made by the U.S. Food and Drug Administration for the week ended May 25.

Approvals

* Novartis AG's Piqray in combination with AstraZeneca PLC's endocrine therapy Faslodex for men and postmenopausal women with HR+, HER2- breast cancer with a PIK3CA mutation that has grown or spread to other parts of the body and has progressed after hormone therapy.

* AveXis Inc.'s Zolgensma as the first and only gene therapy for spinal muscular atrophy. AveXis is a unit of Basel, Switzerland-based Novartis.

* Incyte Corp.'s Jakafi as first treatment for acute graft versus host disease in patients who do not respond to steroid therapy.

* InBios International Inc.'s ZIKV Detect 2.0 IgM Capture ELISA as the first test to diagnose Zika virus immunoglobulin, or IgM, antibodies in human blood.

* NovoCure Ltd.'s NovoTTF-100L System for use in combination with Eli Lilly and Co.'s Alimta and platinum-based chemotherapy as the initial treatment for malignant pleural mesothelioma that has grown outside the lungs or has spread to other parts of the body and cannot be removed via surgery.

* Mayne Pharma Group Ltd.'s Sorilux foam for treating plaque psoriasis in patients aged 12 years and above. The drug was previously approved for use in plaque psoriasis patients aged 18 years and older.

* Roche Holding AG's Cobas test for use in Cobas 6800/8800 Systems to detect trichomonas vaginalis and Mycoplasma genitalium.

* Hologic Inc.'s Aptima Combo 2 assay and Danaher Corp.'s Xpert CT/NG to detect chlamydia and gonorrhea via throat and rectum. The tests were previously cleared for testing urine, vaginal and endocervical samples.

* CD Diagnostics Inc.'s Synovasure Lateral Flow test kit as an aid to detect periprosthetic joint infection in the joint lubricating fluid of patients being evaluated for surgery to replace or compensate for a failed implant, or revision surgery.

* LBT Innovations Ltd.'s APAS Independence instrument with associated urine analysis module for automatic reading of culture plates.

* Qiagen NV's molecular diagnostic system QIAstat-Dx to detect and identify multiple respiratory viral and bacterial pathogens.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

* Avadel Pharmaceuticals PLC's hospital product candidate AV001 for an undisclosed indication.

Breakthrough therapy

* Iovance Biotherapeutics Inc.'s LN-145 for patients with cervical cancer that has spread to other parts of the body or keeps recurring, with disease progression on or after chemotherapy.