On March 16, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS (eflapegrastim) manufacturing site in May 2021 (Press release, Spectrum Pharmaceuticals, MAR 16, 2021, View Source [SID1234576739]). In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic.

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"I am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We believe the pre-approval inspection marks the final step in the ROLONTIS review process."

About ROLONTIS

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

On March 16, 2021 Next-generation sequencing (NGS)-based precision oncology provider Geneseeq Technology Inc. ("Geneseeq"), will collaborate with Illumina, Inc. (NASDAQ: ILMN) ("Illumina") to develop comprehensive in-vitro diagnostic (IVD) NGS testing kits for cancer, using Illumina’s NextSeq 550Dx sequencing platform (Press release, Illumina, MAR 16, 2021, View Source [SID1234576755]). The companies will work together to promote the use and application of world leading Next-Generation-Sequencing technology to enhance standards-of-care for Chinese patients.

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Geneseeq’s comprehensive genomic profiling panel, GeneseeqPrime, analyzes genomic alterations in 425 cancer-related genes and assesses key biomarkers, such as tumor mutation burden (TMB) and microsatellite instability (MSI). This pan-cancer panel screens for actionable clinical next steps to therapy by providing valuable insight into key oncogenic genes and drug resistance mechanisms. In 2020, Geneseeq’s TMB Testing Kit in non-small cell lung cancer (NSCLC) became the first comprehensive NGS panel entered into the Breakthrough Medical Devices Program of Chinese National Medical Products Administration (NMPA).

Geneseeq will conduct all testing studies using IVD instruments and components supplied by Illumina in order to develop and commercialize the IVD kits. The IVD kits will be made available directly to patients acquiring testing services from Geneseeq, as well as hospital testing centers. According to Dr. Xue Wu, CEO and co-founder of Geneseeq Canada, this collaboration will deliver streamlined workflow and produce accurate testing results rapidly. This will help cancer patients access critical information to optimize their treatment plans, and benefit from precision medicine.

"We’re pleased to extend our collaboration with Geneseeq to develop assays based on the newly approved NextSeq 550Dx in China," said Li Qing, Vice President & General Manager of Greater China at Illumina. "Together with partners such as Geneseeq, we are able continuously bring in innovative NGS testing products to patients in China, and ultimately help them by unlocking the power of genome."

This is the second time that the two companies joined forces to accelerate clinical availability in precision cancer care. In 2018, the two companies collaborated on the NMPA approval of the IVD kit, Essencare(EGFR/ALK/ROS1/BRAF/KRAS/HER2 mutation testing kit, Reversible terminator sequencing) for NSCLC.

On March 16, 2021 Isofol Medical reported The approved abstract for the congress American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 has been published on their website (Press release, Isofol Medical, MAR 16, 2021, View Source [SID1234576723]). The congress will take place during April 10-15, 2021 and the poster will be available on April 10.

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On March 16, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that it will report fourth quarter and full year 2020 financial results and provide a corporate update after the market close on Tuesday, March 23, 2021 (Press release, aTyr Pharma, MAR 16, 2021, https://investors.atyrpharma.com/news-releases/news-release-details/atyr-pharma-webcast-conference-call-reporting-fourth-quarter-and [SID1234576740]). Management will host a conference call and webcast to review the results and provide an operational update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On March 16, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that the company will release its fourth quarter 2020 financial results after the market closes on Tuesday, March 30, 2021 (Press release, CohBar, MAR 16, 2021, View Source [SID1234576812]). Management will host a conference call with a slide presentation at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details for the Conference Call and Slide Presentation:

Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 355 3814 and password CWBR, or
Go to www.cohbar.com and click on Q4 2020 Shareholder Presentation at the top of homepage.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 30, 2021, through 11:59 p.m. Eastern Time on April 20, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13717040. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.