Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA

On April 1, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that on March 31, 2022, the Company completed the resubmission of its Biologics License Application ("BLA") for 131I-omburtamab ("omburtamab") to the FDA (Press release, Y-mAbs Therapeutics, APR 1, 2022, View Source [SID1234611336]).

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Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to publish later this year.

"I am excited to see the completion of Y-mAbs’ second BLA submission in neuroblastoma. As children treated for high-risk systemic neuroblastoma potentially experience longer systemic remissions, we expect more patients eventually relapsing with brain metastasis and there is currently no effective therapy beyond surgery and radiotherapy available for these patients." stated Thomas Gad, Founder, Chairman and President. "As the father of a long-term high-risk neuroblastoma survivor, treated with a predecessor to DANYELZA for systemic high-risk neuroblastoma, and when relapsing with CNS/leptomeningeal metastasis, treated with omburtamab, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma. Y-mAbs was initially founded with the goal of potentially getting both these drugs approved in order to make a major impact on families all over the world."

Dr. Claus Moller, Chief Executive Officer, continued, "We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we look forward to working with the FDA to bring omburtamab to the appropriate patients. This is a key milestone for families and patients facing CNS/leptomeningeal metastasis from neuroblastoma and for Y-mAbs."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound.

Boston Scientific Announces Conference Call Discussing First Quarter 2022 Results

On April 1, 2022 Boston Scientific Corporation (NYSE:BSX) reported that it will webcast its conference call discussing financial results and business highlights for the first quarter ended March 31, 2022, on Wednesday, April 27, 2022, at 8:00 a.m. EDT (Press release, Boston Scientific, APR 1, 2022, View Source [SID1234611334]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the first quarter on April 27 prior to the conference call.

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A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of the event.

Eisai Announces Acquisition of Arteryex Shares (Making Arteryex a Subsidiary) to Strengthen and Rapidly Expand the Foundation of its Digital Solution Business

On April 1, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that Eisai has acquired a majority of the shares issued by Arteryex Inc. (Headquarters: Tokyo, CEO: Li Dongying, "Arteryex"), a company that plans and develops software related to digital solutions such as provision of medical information platforms, through purchase of shares and subscription of a third-party allocation of common shares, and made it a subsidiary, as of March 31, 2022 (Press release, Eisai, APR 1, 2022, View Source [SID1234611330]). The two companies will work together to develop and provide PHR (Personal Health Record)-related services for patients, healthcare professionals and society at large.

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Eisai launched its medium-term business plan "EWAY Future & Beyond" in April 2021, where the perspective to be shifted from that of patients to The People or each consumer. With "empowering The People to realize their fullest life" as the vision, Eisai delivers not only pharmaceutical products but also solutions to The People, by utilizing the latest digital technology such as AI, and aims to remove the anxiety of The People.

Arteryex has excellent software development capabilities and has developed its own PHR-related product services, including apps for storing and converting health-related information of patients undergoing treatment and a wide range of users into data, as well as apps for companies for employee health management.

Eisai aims to strengthen and rapidly expand its digital solution business base by acquiring Arteryex’s development capabilities and quality PHR products through the subsidiary acquisition. In addition to reaching a new customer segment of existing products, Eisai will promote developing products including new applications by utilizing Arteryex’s input technology and systems used in image data. Furthermore, Eisai will advance the utilization of data acquired through PHR-related products, as the entire Eisai Group, leveraging the data management know-how that Eisai has practiced in its medicine creation activities and disease awareness activities.

For building the Eisai Universal Platform (EUP), through those initiatives, Eisai will enhance creating a packaged solution, as well as strengthen its delivery infrastructure, for maintenance and improvement of health, prevention and disease awareness, and will expand its contribution to The People.

The current management team of Arteryex will remain after the conversion to a subsidiary. The acquisition by Eisai of Arteryex as a subsidiary will not have a material impact on the consolidated financial results of Arteryex.

CBC Group-backed Hasten Biopharma successfully completes acquisition of five cardiovascular and metabolism drugs from Takeda

On March 31, 2022 Hasten Biopharmaceutic Co., Ltd (China) ("Hasten") reported that it has acquired a portfolio of five prescription pharmaceutical products sold in China from Takeda Pharmaceutical Company Limited (Press release, Takeda, MAR 31, 2022, View Source [SID1234611388]). Hasten is funded by CBC Group ("CBC"), Asia’s largest healthcare-dedicated investment firm, Hefei Industry Investment Group, and Feidong County of Hefei City.

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Under the terms of the acquisition, Hasten will acquire the Chinese Mainland-exclusive rights of Ebrantil, Edarbi, Basen, Blopress and Actos. Employees dedicated to the commercial support of these products will be transferred to Hasten, while Takeda will continue to manufacture the portfolio of products and supply them to Hasten.

"Hasten is dedicated to providing life-transforming treatments for patients in China. Acquiring the five innovative medicines gives Hasten a strong portfolio and a talented commercial workforce, taking it one step closer to becoming a leading biopharmaceutical company in China," Annie Lee, Chairman of the Board of Hasten and CBC Managing Director, said. "I look forward to welcoming our new colleagues from Takeda to Hasten and building on our combined expertise to fulfil unmet needs for patients with critical diabetic and heart conditions."

"This acquisition helps us further our purpose of building a best-in-class primary care platform in Asia," Wei Fu, Chief Executive Officer of CBC, said. "CBC has an excellent track record of building next-generation healthcare companies with our unique investor-operator strategy. We look forward to developing further synergy between our portfolio companies in our healthcare ecosystem to bring life-changing treatments to chronic disease patients."

CBC has built a robust global healthcare ecosystem, partnering with top healthcare entrepreneurs and companies to deliver innovative solutions and improve healthcare efficiency and quality since 2014. Its investor-operator strategy has led the group to complete 9 IPOs across its portfolio, with another 12 life sciences and medical technology companies currently under incubation. CBC has also built momentum expanding its geographical footprint in recent years, including by building RVAC Medicines in Singapore, Jadeite Medicines in Japan, and Ensem Therapeutics in the US. CBC will continue to leverage its strong team of investment, industry, and portfolio management professionals to enhance Hasten’s value and accelerate its growth.

CBC Group-backed Hasten Biopharma successfully completes acquisition of five cardiovascular and metabolism drugs from Takeda

On March 31, 2022 Hasten Biopharmaceutic Co., Ltd (China) ("Hasten") reported that it has acquired a portfolio of five prescription pharmaceutical products sold in China from Takeda Pharmaceutical Company Limited (Press release, Takeda, MAR 31, 2022, View Source [SID1234611388]). Hasten is funded by CBC Group ("CBC"), Asia’s largest healthcare-dedicated investment firm, Hefei Industry Investment Group, and Feidong County of Hefei City.

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Under the terms of the acquisition, Hasten will acquire the Chinese Mainland-exclusive rights of Ebrantil, Edarbi, Basen, Blopress and Actos. Employees dedicated to the commercial support of these products will be transferred to Hasten, while Takeda will continue to manufacture the portfolio of products and supply them to Hasten.

"Hasten is dedicated to providing life-transforming treatments for patients in China. Acquiring the five innovative medicines gives Hasten a strong portfolio and a talented commercial workforce, taking it one step closer to becoming a leading biopharmaceutical company in China," Annie Lee, Chairman of the Board of Hasten and CBC Managing Director, said. "I look forward to welcoming our new colleagues from Takeda to Hasten and building on our combined expertise to fulfil unmet needs for patients with critical diabetic and heart conditions."

"This acquisition helps us further our purpose of building a best-in-class primary care platform in Asia," Wei Fu, Chief Executive Officer of CBC, said. "CBC has an excellent track record of building next-generation healthcare companies with our unique investor-operator strategy. We look forward to developing further synergy between our portfolio companies in our healthcare ecosystem to bring life-changing treatments to chronic disease patients."

CBC has built a robust global healthcare ecosystem, partnering with top healthcare entrepreneurs and companies to deliver innovative solutions and improve healthcare efficiency and quality since 2014. Its investor-operator strategy has led the group to complete 9 IPOs across its portfolio, with another 12 life sciences and medical technology companies currently under incubation. CBC has also built momentum expanding its geographical footprint in recent years, including by building RVAC Medicines in Singapore, Jadeite Medicines in Japan, and Ensem Therapeutics in the US. CBC will continue to leverage its strong team of investment, industry, and portfolio management professionals to enhance Hasten’s value and accelerate its growth.