Jazz Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 4, 2021 Shineco, Inc. ("Shineco" or the "Company"; NASDAQ: TYHT), a producer and distributor of Chinese herbal medicines, organic agricultural and hemp products, reported the Company and Mayah Biological Holdings Limited ("Mayah Biological"), a British Virgin Islands Company headquartered in Taiwan Biomedical Park, had signed a Proposal for Purchase of Equity Interest of Mayah Biological Holding Limited (the "Proposal"), with respect to the potential purchase of at least 51% equity interests in Mayah Biological by the Company (Press release, Shineco, MAY 4, 2021, View Source,%2C%20diabetes%2C%20and%20drug%20abuse. [SID1234579509]).

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The parties to the Proposal agreed to sign a definitive agreement after going through the due diligence progress by both parties. There is no guarantee, however, that the parties to the Proposal will enter into a definitive agreement. If a definitive agreement is not entered into for any reason, none of the parties to the Proposal will have any liability to any other party based on anything related to the non-binding terms of the Proposal.

Mayah Biological is a biotechnology company, which focuses on the development of chemical and biomedicine in the pre-clinical and clinical stages. Mayah Biological is committed to developing new biological targets of small molecule and protein medicines for the treatment of tumors, diabetes, and drug abuse.

Mayah Biological has a strong scientific research team which consists of professors in the field of medicine research and development ("R&D") from prestigious universities in the United States, such as professors of the Department of Molecular and Medical Pharmacology at the University of California, Los Angeles School of Medicine, professors of the Department of Molecular and Cellular Biochemistry at the University of Kentucky Cancer Center, and professors of the Department of Pharmaceutical Sciences at University of Kentucky School of Pharmacy. Each member of the scientific research team has over 30 years of working experience in biotechnology and pharmacy with many scientific research accomplishments.

Mayah Biological currently plans to build over 10 medicine pipelines, covering medicine R&D in the fields of tumor, diabetes and antidote. One drug has completed clinical trial phase 2, one cancer drug is ready for clinical trial phase 2, and three other cancer drugs have completed preclinical preparations to enter clinical trial phase 1. Many drugs in the pipeline are first-in-class drugs, with no similar products in the market. Mayah Biological takes advantages of the combination of years of medicine R&D experience of the scientific research team and AI medicine R&D technology, and is also engaged in the R&D of new me-better medicine with known targets.

By using AI medicine R&D technology and utilizing its scientific research team’s strengths in basic research, medicine design, chemical synthesis, activity testing, animal models, and pathology, Mayah Biological believes it will be able to save about 3-5 years in drug development as compared with traditional medicine R&D companies, decrease the uncertainty of medicine R&D, improve the success rate of medicine R&D, greatly reduce the costs and risks of R&D research, and realize its interest to the most extent.

Mayah Biological is currently introducing medicine pipelines and carrying out follow-up R&D of some pipelines under clinical trials. Mayah Biological believes that its medicines will have broad market prospects and sustainable profitability. For example, Mayah Biological is currently developing proteasome inhibitors and new tumor inhibitors and analgesics: it is estimated that from 2024 to 2031, the total annual sales revenue of proteasome inhibitors for the treatment of prostate cancer will be US$14.611 billion per year, the total sales revenue for the treatment of multiple myeloma will be US$2.081 billion per year, and the total annual sales revenue of new tumor inhibitors and analgesics will be US$3.247 billion per year.

On May 4, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help businesses transform complex data into actionable insights, reported that it will report financial results for its 2021 first quarter on Thursday, May 6, 2021, after market close (Press release, NantHealth, MAY 4, 2021, View Source [SID1234579043]). NantHealth management will host a conference call that same day at 1:30 p.m. PT (4:30 p.m. ET) to review the company’s performance.

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The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 8364209. The call will be broadcast via the Internet at www.nanthealth.com.

On May 4, 2021 Certara, Inc. (Nasdaq: CERT), the global leader in biosimulation, reported the launch of its Secondary Intelligence software, the first and only software that quantitatively predicts the risk of adverse effects and safety issues derived from secondary pharmacology that may impede the clinical development of a drug (Press release, Certara, MAY 4, 2021, View Source [SID1234579070]).

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Safety issues account for approximately one quarter of candidate attrition in drug development projects. They can arise from either intended or unintended drug-receptor interactions, also known as primary or secondary pharmacology, respectively. Secondary pharmacological profiling is increasingly applied by drug developers and assessed by regulators to evaluate the potential of off-target effects of novel drugs. To address secondary pharmacology, researchers typically screen their small molecule compounds against a broad panel of off-target receptors. The challenge is interpreting the readouts to understand which receptor interactions will contribute to potential adverse effects in clinical development and post-marketing.

"While drug developers and regulators rely on secondary pharmacology analyses to support critical development decisions, the current process is inefficient, inconsistent, and often imprecise," said William F. Feehery, Ph.D., CEO of Certara. "With our Secondary Intelligence software, drug developers will be able to make faster, more confident go/no go portfolio decisions earlier in the drug discovery and development process which will help to increase the likelihood of success in clinical trials."

Certara’s Secondary Intelligence software is the only software that curates and visualizes secondary pharmacology analyses to evaluate safety liabilities against multiple receptors. It ranks the likelihood of off-target interaction during clinical use to make critical decisions on which compounds to progress or modify.

"We have unlocked the potential of secondary pharmacology data to provide automated intelligence so that safety pharmacologists and toxicologists can more confidently and consistently predict the off-target safety risks associated with their compounds faster and earlier," said Will Redfern, Ph.D., Vice President, Quantitative Systems Toxicology & Safety at Certara. "Secondary Intelligence allows drug developers to de-risk their programs with evidence-based secondary pharmacology insights, which could save significant time, cost, and resources further down the line."

To learn more about the Secondary Intelligence software and consulting services, please visit: View Source

On May 4, 2021 Exelixis, Inc. (Nasdaq: EXEL) and GamaMabs Pharma SA reported that they have entered into an agreement under which Exelixis will, upon the future closing of the asset purchase and subject to certain conditions to closing, acquire all rights, title and interest in GamaMabs’ AMHR2 antibody technology (Press release, Exelixis, MAY 4, 2021, View Source [SID1234579096]). Exelixis will pay GamaMabs $5 million upon signing of the agreement, make additional payments upon completion of closing conditions, and make additional milestone payments after closing, contingent upon various events. Once the transfer is completed, Exelixis will control 100% of GamaMabs’ AMHR2 franchise technology including all assets pertaining to GamaMabs’ monoclonal antibody drug product murlentamab (GM-102).

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"GamaMabs has generated a compelling body of preclinical data supporting the potential of AMHR2 as a target for novel oncology therapies and demonstrated the safety of an anti-AMHR2 monoclonal antibody in human clinical trials," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "Based on these data, we believe that applying our ADC capabilities to GamaMabs’ panel of antibodies against AMHR2 could yield a promising new addition to our biotherapeutics portfolio. Acquiring GamaMabs’ extensive know-how related to this target, as well as existing drug product and related manufacturing cell lines, will allow us to reduce significantly the development timeline compared with starting an AMHR2 program de novo. This is consistent with our strategy of advancing novel cancer therapies as rapidly as possible in order to enable new treatment options that may provide improved patient benefit."

While AMHR2 expression is normally restricted to ovary, testis and adrenal tissues, it is also expressed in ovarian, endometrial, renal, liver, colon and lung tumors. Murlentamab, a monoclonal antibody targeting AMHR2, was well tolerated when administered on its own in Phase 1 and 2 studies, with no dose-limiting toxicities observed. In early 2021, GamaMabs discontinued development of murlentamab given the modest single-agent efficacy observed in these trials. Although it does not have plans to move murlentamab forward, Exelixis is encouraged by the potential of the AMHR2 target as it pursues the further discovery and development of novel biologics.

"The preclinical and clinical data generated to date for murlentamab support its first-in-class potential in a variety of cancer indications, and we expect that Exelixis’ ADC capabilities and expertise in the development and commercialization of novel cancer therapies will help to realize the full potential of this antibody in addressing unmet patient need," said Stéphane Degove, Chief Executive Officer at GamaMabs. "We believe that placing our AMHR2 franchise with Exelixis will enable rapid and effective development of AMHR2-targeting cancer therapies while providing us with near-term revenue that can support development of our other pipeline programs and technologies."