On May 3, 2022 Fresenius Medical Care reported Dr. Carla Kriwet (51) will become the new CEO the world’s leading provider of products and services for individuals with renal diseases, on January 1, 2023 (Press release, Fresenius, MAY 3, 2022, View Source [SID1234613500]). The Supervisory Board of Fresenius Medical Care Management AG unanimously appointed her to succeed Rice Powell (66), who in accordance with the company’s age limit for Management Board members is stepping down when his contract ends on December 31, after 10 years heading the company. Like Rice Powell, Dr. Carla Kriwet will also be a member of the Management Board of Fresenius Management SE. Helen Giza, Chief Financial Officer of Fresenius Medical Care, will enter a new five-year contract, and in addition to her current positions as CFO and CTO will assume the position of Deputy CEO.

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Dr. Carla Kriwet was most recently CEO and President of BSH Hausgeräte GmbH, a company with €15.6 billion in sales, 62,000 employees and 40 production plants around the world. From 2013 to 2020 she was with the health technology company Royal Philips N.V. in the United States, since 2017 as a member of the company’s Executive Board. At Philips she headed the Connected Care division, which includes the business areas Patient Care and Monitoring Solutions as well as Healthcare Informatics.

Previously, Dr. Carla Kriwet was a member of the Executive Board of the non-governmental organization Save the Children Germany in Berlin, and Chief Sales & Marketing Officer at the medical technology company Drägerwerk in Lübeck, Germany. Between 2003 and 2010 she held various management positions in the strategy department and in the Healthcare division of Linde AG, lastly as Head of Linde Healthcare Europe. Before that, she spent six years with the Boston Consulting Group, where, among other responsibilities, she headed consulting projects in healthcare. Dr. Carla Kriwet started her career in project management at ABB Daimler-Benz Transportation in India in 1995, after working as a volunteer for an SOS Children’s Village in Burundi and studying business at Switzerland’s University of St. Gallen, where she graduated with a doctorate degree.

Rice Powell joined Fresenius Medical Care in 1997, and as CEO of Fresenius Medical Care North America was appointed to the Management Board of Fresenius Medical Care in 2004. He has been the company’s CEO since January 1, 2013. Under his direction, Fresenius Medical Care significantly extended its global leadership, identifying emerging business areas such as value-based care and home dialysis early and then expanding successfully into them.

Rice Powell said: "After 25 years with this company, and a full decade as CEO, I look back with a lot of gratitude and pride at what we achieved during this time. Our products and services are more important than ever to our patients, and a fundamental part of their lives. As the world’s only provider of the full range of innovative therapies and products for people with renal diseases, we have outstanding prerequisites for our continued success. I want to thank all my colleagues – on the Management Board, the management team, and everyone in all our facilities worldwide – for their untiring efforts and support over the years. I’m very happy to know that our company will be in good hands in the future."

Stephan Sturm, Chairman of the Fresenius Medical Care Management AG Supervisory Board and CEO of Fresenius, said: "I am very thankful to Rice Powell for his highly dedicated service over many years, and for his important contribution to our success. He played a key role in shaping Fresenius Medical Care, initiated future-looking developments and set in motion the necessary transformation of the company. On behalf of the entire Supervisory Board and the Management Board of Fresenius, I wish Rice all the very best for the next stage of his life, with more time for his family and hobbies. At the same time, I am very much looking forward to working with Dr. Carla Kriwet. I have come to know her as a highly skilled and bold manager with a lot of experience in the healthcare industry, clear ideas and a lot of empathy. People’s health and well-being are very close to her heart, and something she has worked for over the years in different organizations and constellations. I’m certain that working closely with Helen Giza, and together with the entire management team, she will successfully shape the transformation now underway and manage the challenges, not least those created by the pandemic, embrace with enthusiasm the numerous growth opportunities before us, and lead Fresenius Medical Care to continued success."

Dr. Carla Kriwet said: "I am very much looking forward to taking on this new position and working together with my new colleagues. I fully identify with the vision of making the lives of the patients who have put their trust in us a little more worth living every day. And I’m convinced that bringing ever better medicine to ever more people goes hand in hand with economic success. Early in my professional development, I found my way into the healthcare business and have remained very closely connected to it ever since. Fresenius Medical Care is a globally active, leading and unique company that still has tremendous potential. I want to do my part to leverage this potential for the benefit of patients and employees, and in doing so also add shareholder value."

On May 3, 2022 Enveric Biosciences Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that its Board of Directors declared a dividend of one one-thousandth of a share of newly-designated Series C Preferred Stock, par value $0.01 per share, for each outstanding share of Enveric common stock held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (Press release, Enveric Biosciences, MAY 3, 2022, View Source [SID1234613464]). The outstanding shares of Series C Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a proposal to increase the number of authorized shares of the Company’s common stock, a proposal giving the Board of Directors the authority, as it determines appropriate, to implement a reverse stock split within twelve months following the approval of such proposal by the Company’s stockholders, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the foregoing matters, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series C Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series C Preferred Stock).

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All shares of Series C Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the above described proposals as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series C Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by Enveric’s Board of Directors or automatically upon the approval by Enveric’s stockholders of the above described proposals.

The Series C Preferred Stock will be uncertificated, and no shares of Series C Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series C Preferred Stock equal to the number of shares of Enveric’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series C Preferred Stock will be contained in a report on Form 8-K to be filed by Enveric with the Securities and Exchange Commission.

On May 3, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Camille Bedrosian, M.D., the company’s Chief Medical Officer, and Mardi Dier, the company’s Chief Financial Officer, will present at the BofA Securities 2022 Healthcare Conference on Tuesday, May 10, 2022 at 5:40 PM ET (Press release, Ultragenyx Pharmaceutical, MAY 3, 2022, View Source [SID1234613463]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On May 3, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Bank of America Securities 2022 Healthcare Conference at 11:20 a.m. Pacific Time (2:20 p.m. Eastern Time) on Tuesday, May 10, 2022 in Las Vegas (Press release, Neurocrine Biosciences, MAY 3, 2022, View Source [SID1234613462]). Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On May 3, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMOBC) have been published in Breast Cancer Research and Treatment (Press release, NanOlogy, MAY 3, 2022, View Source;utm_medium=rss&utm_campaign=nanology-publishes-results-from-a-phase-1-2-clinical-trial-of-its-topical-investigational-drug-in-the-treatment-of-cutaneous-metastases-of-breast-cancer [SID1234613461]).

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The research article entitled Phase 1/2 Study of Topical Submicron Particle Paclitaxel for Cutaneous Metastases of Breast Cancer presents final safety and response data from the multi-site study (NCT03101358). Clinical investigators included Mario Lacouture, MD (Memorial Sloan Kettering Cancer Center), Julie Lang, MD (formerly USC Norris Comprehensive Cancer Center; currently Cleveland Clinic), and Sant Chawla, MD (Sarcoma Oncology Research Center).

The dose escalation/expansion trial enrolled 23 subjects across the three sites, 21 of whom had CMOBC. Three concentrations of SOR007 were evaluated (0.15%, 1.0%, and 2.0%) applied twice daily for 28 or 56 days. The primary endpoint of the study was safety and tolerability. Secondary endpoints included lesion response, lesion pain reduction, and pharmacokinetic (PK) analysis.

SOR007 was well tolerated at all concentrations allowing the 2.0% concentration to continue to the dose expansion phase of the trial. No confirmed drug-related serious adverse events were recorded, local skin reactions were minor, and systemic absorption of paclitaxel was negligible.

Lesion response was evaluated by dimensional change (RECIST 1.1) with 19 subjects evaluable at 28 days and 8 evaluable at 56 days. At the 28-day and 56-day assessments, overall response rate was 16% (3/19) and 25% (2/8), respectively. Similarly, 15/19 (79%) and 6/8 (75%) were progression free. Some lesion pain reduction was observed in 7/11 (64%) of subjects who reported pain at baseline.

Approximately 168,000 people are living with metastatic breast cancer in the United States and up to a quarter (40,000) may develop cutaneous metastases (BCRF [2021]; Krathen [2003] South Med J). CMOBC are progressive malignant skin lesions that can cause severe local pain, ulceration, disfigurement, discharge, malodor, bleeding, and infection. The negative impact to quality of life for these patients can be devastating.

NanOlogy is considering partnership strategies for further development and commercialization of SOR007, which has therapeutic potential in CMOBC and other dermal cancers.

"Cutaneous metastases are extremely troublesome for the patient and oncologist alike as the lesions are a daily reminder of the underlying metastatic disease and there are few treatment options currently available," said Mario Lacouture, MD, Director, Oncodermatology Program, Memorial Sloan Kettering Cancer Center. "In this Phase 1/2 clinical trial, SOR007 showed promising signs of preventing lesion progression and reducing lesion pain. Further clinical research is warranted to confirm these findings."

In addition to SOR007, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, bladder, peritoneal, ovarian, and prostate cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts oncology active ingredients into stable large surface area microparticles of pure drug optimized for tumor-directed therapy and continuous drug release. Taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, US 10,993,927, and US 11,123,322) Canada, Europe, Japan, China, Russia, and Australia all valid through June 2036. The topical formulation is covered by formulation and method of treatment patents issued in the US (US 10,449,162, US 10,918,606, US 10,555,898, US 10,842,736, & US 11,191,717) and Japan. The composition and formulation patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, methods, and technology.