Market Newsdesk

– Highly accomplished attorney joins Sera to develop its legal and intellectual property functions –

SALT LAKE CITY, April 13, 2021 (GLOBE NEWSWIRE) — Sera Prognostics, Inc., The Pregnancy Company™, focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the appointment of Benjamin G. Jackson as General Counsel. Mr. Jackson joins Sera Prognostics to develop its internal legal and intellectual property capabilities, as Sera transitions from a rigorous scientific and data-driven clinical stage company into an emerging commercial-stage company.

For the last 15 years, Ben has represented Myriad Genetics, Inc., beginning as a law clerk, initially focusing on intellectual property, and ultimately advancing to become General Counsel of a global molecular diagnostics enterprise. Mr. Jackson is viewed as a thought leader who has written and presented extensively in the area of molecular diagnostics intellectual property, while also possessing broad experience in a wide range of legal matters, including patent and commercial litigation, M&A transactions, interactions with government and private payers, corporate legal policies and contracting.

“It is great to have the opportunity to be working again very closely with Ben Jackson, as Sera Prognostics commercially distributes pivotal pregnancy information to physicians and expectant mothers,” said Gregory C. Critchfield, M.D., M.S., Chairman and CEO. “I am convinced that Ben’s legal skills, business acumen and real-world experience in complex and weighty legal matters will help Sera to better achieve its vision of improving the health of mothers and babies and reducing the costs of healthcare delivery.”

“Sera has made great strides in building evidence that PreTRM^® testing improves the ability to identify pregnancies that are at higher risk of preterm delivery, thereby enabling proactive interventions designed to help address the immense burden of premature birth,” said Ben Jackson. “I am personally energized to join Sera, working with Greg and the rest of the talented Sera team to help drive the company’s progress to improve the lives of mothers and newborns. I believe Sera has great potential to help mitigate the enormous personal, societal and economic consequences of premature births and other adverse pregnancy consequences.”

About Sera Prognostics, Inc.

Sera Prognostics is the leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera delivers pivotal information in early pregnancy to physicians and expectant mothers, designed to enable them to improve maternal and neonatal health and reduce healthcare costs. Sera’s precision medicine PreTRM^® test reports to a physician the individualized risk of premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. In addition to the PreTRM^® test, Sera has a robust pipeline of innovative blood-based biomarker tests focused on the early prediction of other serious complications of pregnancy. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company’s website at www.seraprognostics.com.

About Preterm Birth

Preterm birth is defined as any birth before 37 weeks’ gestation and is the leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that of approximately 3.8 million babies born annually in the U.S., more than one in ten is born prematurely.¹ Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual US health care costs to manage complications of prematurity were estimated to be approximately $25 billion for 2016.²

About the PreTRM^® Test

The PreTRM^® test is the only broadly clinically validated commercially available blood test that provides an early individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. The PreTRM^® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM^® test permits physicians to identify, as early as 19 weeks of pregnancy, which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk, so that her care can be personalized to address her risk. The PreTRM^® test is ordered by a medical professional. For more information about the PreTRM^® test, please visit www.PreTRM.com and the PreTRM^® Test YouTube Channel. You can also join the conversation on Facebook and @PreTRM.

References

1. Martin JA, et al. Births: Final Data for 2019. National Vital Statistics Reports; vol 70 no 2. Hyattsville, MD: National Center for Health Statistics. 2021. DOI: https://dx.doi.org/10.15620/cdc:100472
2. Waitzman NJ, et al. Preterm birth lifetime costs in the United States in 2016: An update. Semin Perinatol. 2021 Jan 24:151390. doi: 10.1016/j.semperi.2021.151390. Epub ahead of print. PMID: 33541716.

Contact

Erich Sandoval, Lazar FINN
[email protected]
+1 917 497 2867

Tampa, FL, April 13, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — B2Digital Incorporated (the “Company”, “B2”, or “B2Digital”) (OTCMKTS:BTDG), the premier development league for mixed martial arts (“MMA”), is excited to announce the signing of two significant lease agreements integrating two top MMA training firms into the Company’s Gym segment. Each deal has the potential to act as a pipeline for fighter talent as well as a revenue driver through both lease payments and ONE MORE Gym membership dues.

Team Colon MMA (TeamColonMMA.com) will be moving into the Company’s ONE MORE Gym location in East Chicago/Merrillville, Indiana, and Cobra Brazilian Jiu-Jitsu (CobraBJJTuscaloosa.com) will be moving into the Company’s ONE MORE Gym location in Tuscaloosa, Alabama.

Steve Colon of Team Colon MMA remarked, “We are thrilled to join forces with ONE MORE Gym and B2Digital. This deal will help us expand our reach and bring in and develop new talent with more space and better training resources, ultimately producing higher caliber fighters ready to move toward a bright future in mixed martial arts.”

Kurtis Taylor of Cobra Brazilian Jiu-Jitsu added, “At the end of the day, it’s about providing value to our fighters and helping them reach their full potential. ONE MORE Gym will help us accomplish that goal while giving us access to a facility that allows us to expand our business and help create more future stars.”

Between lease fees and increased membership dues, the Company believes these deals will drive an increase in overall topline revenues for ONE MORE Gym. In addition, given the prestige and success of both of these training outfits, the Company stands to gain long-term value in the form of top fighting talent graduating into its B2 Fighting Series LIVE MMA event segment.

“Each piece of the puzzle reinforces the whole ecosystem we are building,” noted Greg P. Bell, CEO of B2Digital. “Both Team Colon and Cobra represent true blue-chip training firms. That ultimately helps reinforce our brand value at both the gym and event levels while we believe it will help drive positive growth and revenue for ONE MORE Gym. It also gives Steve and Kurtis more space and resources to produce better fighters who could become feature stars on the B2 Fighting Series stage.”

About B2Digital Inc.
With extensive background in entertainment, television, video, and technology, B2Digital (OTC: BTDG) is now forging ahead and becoming a full-service live event sports company. Capitalizing on the combination of B2Digital CEO Greg P. Bell’s expertise and involvement with more than 40,000 live events over his career for major sports leagues and entertainment venues, B2Digital is in the process of developing and acquiring MMA and sports-related companies to build an integrated Premier Development League, Expand the B2 Official Training Facility Program Network and Continue the growth of the B2 Social Media Network for the multibillion-dollar mixed martial arts (“MMA”) industry.

B2Digital intends to create and develop league champions that will move on to the MMA major leagues from the Company’s B2 Fighting Series brand. Each year, the top fighters will be invited to the annual B2 Fighting Series National Championship live event.

B2Digital has developed and deployed the systems and technologies for the operation of the B2 Fighting Series, “B2FS”. This includes social media marketing, event management, digital ticketing sales, digital video distribution, digital marketing, PPV, FTV (Free to View), merchandise sales, brand management and financial control systems. B2Digital owns all rights for TV, internet, social media, media, merchandising and trademarks, and branding for the B2Digital companies.

For more information about B2Digital, visit the Company’s website at www.b2digitalotc.com.

B2Digital has a growing social media presence. Follow us on:
Twitter: @B2digitalOTC
Facebook: https://m.facebook.com/b2digitalotc/

B2Digital: MMA’s Premier Development League
www.b2digitalotc.com

B2 Fighting Series Pay Per View Link
www.b2mma.com

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Press Release contains forward-looking statements within the meaning of the securities laws. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

For more information, please contact:

[email protected]

Public Relations:

Tiger Marketing & Branding Agency
[email protected]

LEAD PLAINTIFF DEADLINE IS JUNE 1, 2021

NEW YORK, April 13, 2021 (GLOBE NEWSWIRE) — Wolf Haldenstein Adler Freeman & Herz LLP announces that a federal securities class action lawsuit has been filed in the United States District Court for the District of New Jersey on behalf of those who acquired SOS Limited (“SOS” or the “Company”) (NYSE: SOS) American Depositary Receipts (“ADR’s”) during the period from July 22, 2020, through February 25, 2021, inclusive (the ”Class Period”).

All investors who purchased the ADR’s of SOS Limited
and incurred losses are urged to contact the firm immediately at

[email protected]

or (800) 575-0735 or (212) 545-4774. You may obtain additional information concerning the action or

join the case

on our website,

www.whafh.com.

If you have incurred losses in the ADR’s of SOS Limited., you may,no later than June 1, 2021, request that the Court appoint you lead plaintiff of the proposed class. Please contact Wolf Haldenstein to learn more about your rights as an investor in the ADR’s of SOS Limited.

PLEASE CLICK HERE TO JOIN CASE

The filed complaint alleges that throughout the Class Period, defendants made materially false and/or misleading statements, as well as failed to disclose to investors:

• SOS had misrepresented the true nature, location, and/or existence of at least one of the principal executive offices listed in its SEC filings;
• HY and FXK were either undisclosed related parties and/or entities fabricated by the Company;
• the Company had misrepresented the type and/or existence of the mining rigs that it claimed to have purchased; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On February 26, 2021 Hindenburg Research (“Hindenburg”) and Culper Research (“Culper”) released commentary on SOS, claiming that the Company was an intricate “pump and dump” scheme that used fake addresses and doctored photos of crypto rigs to create an illusion of success.

On this news, SOS’s ADR price declined by $1.27 per ADR, or approximately 21.03%, to close at $4.77 per ADR on February 26, 2021.

Wolf Haldenstein has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.

If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735, via e-mail at [email protected], or visit our website at www.whafh.com.

Contact:

Wolf Haldenstein Adler Freeman & Herz LLP
Kevin Cooper, Esq.
Gregory Stone, Director of Case and Financial Analysis
Email: [email protected], [email protected] or [email protected]
Tel: (800) 575-0735 or (212) 545-4774

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

MISSISSAUGA, Ontario, April 13, 2021 (GLOBE NEWSWIRE) — Buchanan Technologies, a leading managed IT services provider, today announced it was recognized with the 2021 HDI Pinnacle of Excellence Award for having 100% of its support center staff HDI certified. This marks Buchanan’s fifth consecutive year to receive this recognition.

HDI has acknowledged Buchanan’s commitment to excellence as one of only a few organizations that fully trains and certifies every service desk team member in HDI’s best practices, including front-line staff, managers, and directors.

“It is an honor for our organization to receive the HDI Team Certified Pinnacle of Excellence award for the fifth year in a row,” said Thomas Nieuwhof, Director of Operations for Support Center Services at Buchanan. “We believe that having a 100% HDI certified support center positions our organization as a market leader and provides value to the customers we serve, and we are committed to the continued growth and improvement of our support center organization while maintaining superior service levels.”

Buchanan supports over half a million end users across multiple key industries, including education, healthcare, automotive, retail, and manufacturing, and supports key business applications with its ever-expanding IT support services. Through five service delivery centers, Buchanan’s team of over 140 agents is committed to providing an unmatched client experience, supporting multiple time zones and a variety of languages around the globe, all to ensure users receive assistance when needed.

HDI
is the leading events and services organization empowering the technical support and service management industry and its people. To view the full list of HDI team certified award recipients, click here.

About Buchanan Technologies:

Established in 1988, Buchanan Technologies is an award-winning managed services provider offering innovative IT services and customized solutions to mid-tier and enterprise-level organizations across the United States, Canada and Europe. Buchanan offers flexible and customizable solutions to accommodate any IT need – whether it’s help desk support, IT field services or managed IT solutions – and believes every interaction matters with each customer to provide a seamless user experience. To learn how Buchanan can simplify your IT solution, visit www.buchanan.com.

Buchanan Technologies media contact:
LaRessa Cox, Vice President of Marketing
[email protected]
972.910.7544

FLORHAM PARK, N.J., April 13, 2021 (GLOBE NEWSWIRE) — Celularity Inc. (“Celularity”), a clinical-stage biotechnology company, leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic therapies derived from the postpartum human placenta, announced today the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, for the treatment of patients with malignant gliomas. CYNK-001 is currently being investigated in a phase 1 clinical trial (NCT04489420) for the treatment of patients with glioblastoma multiforme (GBM), an indication within the scope of this orphan designation.

“We are very pleased the FDA has granted Orphan Designation in malignant gliomas to continue to develop off-the-shelf therapies for serious unmet clinical needs,” said Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity. “Building on the FDA’s recent decision to grant Fast Track status to CYNK-001, we view the Orphan Drug Designation as yet another milestone on our journey to deliver patients a potentially novel treatment. To date, we have observed the potential of CYNK-001 in multiple preclinical models as well as early evidence of activity in the clinic and believe this approach may shift the paradigm in augmenting the body’s natural immune response to diseases such as glioblastoma, other cancer indications and infectious diseases. We are very excited to continue working with the FDA on the development of this exciting therapy.”

About Orphan Drug Designation

The Orphan Drug Act (ODA) encourages biotechnology and pharmaceutical companies to develop drugs for conditions which affect fewer than 200,000 people in the United States by providing economic incentives. To qualify for orphan designation, both the drug and the condition must meet criteria specified in the ODA and FDA’s implementing regulations 21 CFR Part 316. Orphan designation qualifies the drug sponsor for development incentives including tax credits for qualified expenses, reduction in the FDA user fee, and seven years of exclusivity for a drug that obtains approval.

About Malignant Gliomas

Glioma is a type of tumor that occurs in the brain and spinal cord. Malignant gliomas consist of glioblastoma multiforme (GBM), anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, anaplastic ependymoma, and anaplastic ganglioglioma. Malignant gliomas are associated with high morbidity and mortality. GBM accounts for the majority of malignant gliomas. Currently there are no effective long-term treatments for the disease. Patients with GBM usually survive less than 15 months following diagnosis. In most patients, the rapidly growing malignant tumor tends to recur within 6-8 months following treatment. Patients with recurrent GBM have even poorer prognosis. Therefore, malignant gliomas, such as GBM, are serious diseases with high unmet medical needs.

About CYNK-001 

Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases.

About Celularity

Celularity, headquartered in Florham Park, N.J., is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies, including unmodified NK cells, genetically-modified NK cells, T cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs) targeting indications across cancer, infectious and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.

In January 2021, Celularity entered into a definitive merger agreement with GX Acquisition Corp. to create a publicly listed leader in allogeneic cellular therapy. GX Acquisition Corp. is listed on Nasdaq under the ticker symbol “GXGX.” Upon closing of the business combination, expected to be completed in the second quarter of 2021, shares of the combined company will be listed on Nasdaq under the ticker symbol “CELU.”

To learn more, visit celularity.com.

Celularity Investor Contacts:

Carlos Ramirez
Celularity
[email protected]

Alexandra Roy
Solebury Trout
[email protected]

Celularity Media Contact
Jason Braco, Ph.D.
LifeSci Communications
(646)-751-4361
[email protected]

Boca Raton, FL, April 13, 2021 (GLOBE NEWSWIRE) — Spectrum Global Solutions, Inc. (the “Company” or “Spectrum”) (OTCQB: SGSI), a single-source provider of next-generation communications network and professional services to telecommunications and enterprise markets, announces today the Company has formed SVC, Inc. (“SVC”) a Delaware corporation, and entered into a definitive agreement  to acquire the business of Telecom Assets Corp., (“TAC”) a wholesale network services provider with network footprint and licenses in the Northeast, Texas, and Southeast. This network carries VoIP and other traffic for other service providers.  The purchase will be accomplished through a combination of cash and stock valued at approximately $9 Million. The closing on this acquisition is subject to financing and other closing conditions.  The business will be managed by SVC under an interim transition services agreement effective immediately.

This transaction is expected to be accretive to earnings upon closing.  The acquired assets provide strong recurring revenues and a history of significant profitability, with unlimited potential for scale.  The new assets and the nearly 200 channel partners will become part of the Overwatch portfolio of recurring revenue services and leverage the combined sales channels of High Wire Networks and Spectrum.

Mark Porter, newly appointed CEO of Spectrum, stated, “This transaction presents a unique growth opportunity for the Company- a highly profitable recuring revenue stream at approximately $8 million run rate annually and an opportunity to provide immediate tangible value to our shareholders. The network assets and intellectual property we will acquire come at a very favorable valuation and add a platform for additional growth, organically and through acquisition with tremendous growth possibilities.”

“TAC’s service provider customer base also represents an opportunity for growth within High Wire’s Overwatch Managed Security marketplace sales channel,” continued Porter. “Everything we are working on is about two things- creating lasting value and accelerating our business. We will go faster.” 

About Spectrum Global Solutions
Spectrum Global Solutions operates through its subsidiaries, AW Solutions Puerto Rico, ADEX Corp and Tropical Communications. The Company is a leading provider of telecommunications engineering and infrastructure services across the United States, Canada, Puerto Rico, Guam and Caribbean. For more information about the Company and its technologies visit the Company’s public filings at www.SEC.gov or the Company’s website at https://SpectrumGlobalSolutions.com/

About High Wire Networks.
           

For 20 years, High Wire Networks has been a trusted partner to VARs, MSPs, distributors, integrators, manufacturers, and telecom providers by enabling them to minimize overhead while extending delivery capabilities around the world. Our flexible workforce delivers vendor-agnostic technical field, professional and security services in more than 180 countries. Our services include design, installation, configuration, and support for unified communications, wired and wireless networks, cabling and infrastructure, and electrical systems. Our new Overwatch Managed Security Platform-as-a-Service enables our partners to deliver comprehensive cybersecurity that’s easy to sell and easy to buy for an affordable subscription. We also offer a variety of on-demand, rapid-response solutions with service levels ranging from two hours to the next business day for onsite break-fix and remote technical support. With High Wire Networks, partners Get Work Done. Learn more at http://www.highwirenetworks.com

Forward-Looking Statements:

The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as “anticipate,” “appear,” “believe,” “could,” “estimate,” “expect,” “hope,” “indicate,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “will,” “would,” and other variations or negative expressions of these terms, including statements related to expected market trends and the Company’s performance, are all “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.

Investor Relations

Spectrum Global Solutions
www.SpectrumGlobalSolutions.com/ 
561.672.7068 

Media Relations
Susanna Song
Director of Marketing Communications
[email protected]

Helsinn announces poster presentation at Academy of Managed Care Pharmacy (AMCP) 2021 Virtual Meeting evaluating healthcare resource utilization in CINV

Lugano, Switzerland,
April 13, 2021 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare disease products, is pleased to announce that a poster  entitled “Avoiding Acute Care and Unplanned Hydrations from Chemotherapy-Induced Nausea and Vomiting (CINV) in Real World Practice” will be presented at this year’s Academy of Managed Care Pharmacy (AMCP) National Meeting taking place virtually on 12-16 April.

CINV is included among the toxicities tracked by Medicare’s OP-35 oncology outcome measure and was shown as one of the main drivers of acute care events during chemotherapy, representing one in nine acute care events. Reducing avoidable acute care utilization has the potential to improve cancer care and reduce costs. In this analysis Medicare data on resource use were collected and combined with patient records from 17 oncology practices in IntegraConnect’s database from January 2017 through August 2020. CINV acute care utilization and unplanned hydrations after highly or moderately emetogenic chemotherapy (HEC/MEC) with netupitant and palonosetron (NEPA) plus dexamethasone or other triple prophylaxis treatment were evaluated.

The poster presentation will take place on Tuesday, April 13 and Wednesday, April 14, from 1-2:30pm ET

Details of the abstract are as follows:

Abstract ID: 975896

Title: Avoiding Acute Care and Unplanned Hydrations from Chemotherapy-Induced Nausea and Vomiting (CINV) in Real World Practice.

Authors: Gary Binder, MBA, Jeffrey A. Scott, MD, Lee Schwartzberg, MD, Eric J. Roeland, MD, Lindsay Gingras, MHSA, Rudolph M. Navari, MD, PhD

William L. Bailey, Helsinn Therapeutics (U.S.) Vice President of Medical & Scientific Affairs, commented: “CINV is an avoidable toxicity and its prevention remains suboptimal, directly affecting patient care, healthcare resource utilization and impacting total cost of care. These data provide useful information about lowering the risk of CINV-related acute care and unplanned hydrations, an important consideration in assessing the overall value and cost-effectiveness that NEPA may bring to patients and practices.”

About NEPA (AKYNZEO^®)

In the EU:

AKYNZEO^® (netupitant 300mg/palonosetron 0.5mg) capsules for oral use was approved in May 2015 in the EU. A line extension to introduce the IV formulation AKYNZEO^® (fosnetupitant 235mg/palonosetron 0.25mg) powder for concentrate for solution for infusion was approved in March 2020 in the EU. Fosnetupitant is a netupitant prodrug, which converts into netupitant once administered intravenously. Akynzeo^® (oral and IV) is indicated in the EU for adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.

For additional information please see the EU Summary of Product Characteristics.

In the US:

AKYNZEO^® is the first and only 5-HT₃ and NK₁ receptor antagonist fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO^® given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for 5 full days.

INDICATION

AKYNZEO^® (netupitant 300mg/palonosetron 0.5mg) capsules was approved in October 2014 in the United States and is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. 

AKYNZEO^® (fosnetupitant 235mg/palonosetron 0.25) for injection was approved in April 2018 and AKYNZEO^® injection was approved in May 2020 in the United States. Each is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. 

Limitations of Use

• AKYNZEO^® for injection and AKYNZEO^® injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

AKYNZEO^® is a combination of palonosetron, a serotonin-3 (5-HT₃) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-₁) receptor antagonists: palonosetron prevents nausea and vomiting mainly during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

• Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO^®, with or without known hypersensitivity to other 5-HT₃ receptor antagonists.
• Serotonin syndrome has been reported with 5-HT₃ receptor antagonists alone but particularly with concomitant use of serotonergic drugs.  Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO^® and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO^® is used concomitantly with other serotonergic drugs.

Adverse Reactions

• Most common adverse reactions for AKYNZEO^®: headache, asthenia, dyspepsia, fatigue, constipation and erythema

Drug-drug Interactions

• Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4 isoenzyme. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO^®. The inhibitory effect on CYP3A4 can last for multiple days
  • Dexamethasone doses should be reduced when given with AKYNZEO^®. A more than two-fold increase in the systemic exposure of dexamethasone was observed 4 days after a single dose of netupitant or a single infusion of fosnetupitant
  • Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO^®. When administered with netupitant, the systemic exposure to midazolam was significantly increased
• Avoid concomitant use of AKYNZEO^® in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO^®

Use in Specific Populations

• Avoid use of AKYNZEO^® in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease
• Avoid use in pregnancy, limited data is available, may cause fetal harm.

For more information about AKYNZEO^® please see the full 


US Prescribing Information

About the Helsinn Group

Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisitions to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with long-standing partners in 190 countries, who share our values. The Group’s pharmaceutical business, (Helsinn Healthcare) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) which market the Group’s products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals, a drug product manufacturer). Helsinn Investment Fund was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.

Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

To learn more about Helsinn Group please visit www.helsinn.com

For more information:

Helsinn Group Media Contact:

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

Email: [email protected]

For more information, please visit


www.helsinn.com


and follow us on


Twitter


,


LinkedIn


and

Vimeo

HELS–0011

Company announcement – No. 21/ 2021

Boehringer Ingelheim and Zealand Pharma Advance to Phase 2 Clinical Testing in NASH and Obesity

• New studies mark an important advancement of Boehringer Ingelheim’s cardiometabolic focus areas obesity and NASH.
• The GLP-1/glucagon dual agonist BI 456906 may offer important benefits on both chronic weight management and NASH improvement.
• The Phase 2 trials for BI 456906 in obesity and NASH are part of the long-term collaboration between Boehringer Ingelheim and Zealand Pharma, with a prior Phase 2 trial of BI 456906 in people with type 2 diabetes initiated in 2020.

Ingelheim, Germany and Copenhagen, Denmark, 13 April, 2021 – Boehringer Ingelheim and Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) announced the initiation of two Phase 2 trials of the GLP-1/glucagon dual agonist BI 456906 for adults who are overweight or obese and for adults with non-alcoholic steatohepatitis (NASH). The compound was in-licensed from Zealand in 2011 and is being investigated in an ongoing Phase 2 study in people with type 2 diabetes mellitus. The once-weekly therapy may offer additional benefits on both chronic weight management, and NASH improvement and prevention of the progression to cirrhosis compared to currently available treatments with mono GLP-1 agonist compounds. BI 456906 is part of Boehringer Ingelheim’s growing portfolio in the obesity and NASH disease areas.

“Obesity and NASH are areas of high unmet medical need, with limited approved treatments currently available. They are associated with lower quality of life and increased mortality,” explains Prof. Arun J. Sanyal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine in Richmond, Virginia. “I hope that this new approach will bring a much-needed treatment option for HCPs and people afflicted with obesity or NASH.”

Boehringer Ingelheim and Zealand have a fruitful longstanding partnership, bringing together Zealand’s expertise in the discovery of innovative peptide-based medicines with Boehringer Ingelheim’s expertise in the research and development of novel medicines for cardiometabolic diseases. “We are very excited to see the initiation of Phase 2 trials of BI 456906 for obesity and NASH,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “By combining GLP-1 and glucagon agonism mechanistically, we believe our dual agonist has the potential to achieve increased weight loss, via improvement of the patient’s metabolism, and also has potential to alleviate NASH by reducing upstream steatosis.”

“Our cardiometabolic research and development is focusing on discovering novel treatments for obesity and non-alcoholic steatohepatitis (NASH), to meet the large unmet need among these groups,” explains Waheed Jamal, MD, Head of Cardiovascular, Metabolic and Respiratory Medicine at Boehringer Ingelheim. “We are exploring a number of unique approaches with great potential to help people living with obesity or NASH. We believe dual agonists are next generation drug candidates with a potential for higher efficacy in weight loss and NASH improvement/cirrhosis prevention.”

Under the terms of the GLP-1/glucagon dual agonist licensing agreement, Boehringer Ingelheim funds all research, development and commercialization activities. Zealand is entitled to receive up to EUR 345 million in outstanding milestone payments. No milestone payments are due with the initiations of these Phase 2 studies. The agreement also carries high-single digit to low-double digit percentage royalties on global sales.

About the Studies

The Phase 2 randomized double-blind placebo-controlled dose-finding trial (NCT04667377) will evaluate BI 456906 in people with obesity or who are overweight with a BMI  27 kg/m² or higher without diabetes. Participants will receive a subcutaneous injection of either BI 456906 or placebo once a week for the duration of the trial. The primary endpoint of this trial is the percentage change in body weight at week 46 compared to placebo.

The other Phase 2 randomized double-blind placebo-controlled dose-finding trial (NCT04771273) will evaluate BI 456906 in people with NASH and liver fibrosis (F2/F3) with and without diabetes. The primary endpoint of this trial is the histological improvement of steatohepatitis without worsening of fibrosis after 48 weeks of treatment. Participants will receive a weekly subcutaneous injection of either different doses of BI 456906 or placebo for the duration of the trial.

About Obesity

Obesity is a complex chronic disease that requires long term management. It is among the leading risk factors for several cardio-metabolic diseases such as heart disease, ischemic stroke, liver diseases incl. NASH and type 2 diabetes, as well as for a number of cancers. Worldwide obesity has nearly tripled since 1975, with nearly 2 billion adults considered overweight (BMI ≥ 25 kg/m²) in 2016, of which 650 million are considered having obesity (BMI ≥ 30 kg/m²).

About NASH

Non-alcoholic steatohepatitis (NASH) is caused by the buildup of fat in the liver and is one of the major causes of liver fibrosis and cirrhosis. It is an area of high unmet medical need with no approved treatments currently available. NASH is the more serious form of non-alcoholic fatty liver disease (NAFLD), which is the most common liver disease in Western industrialized nations. NASH and NAFLD are especially prevalent in, but not limited to, people with metabolic disorders such as type 2 diabetes and obesity. Today one out of four adults are assumed to have NAFLD. The prevalence of NASH has been estimated to range from 6.67% in Asia and 29.85% in North America for people with mild NAFLD, to reach the peak of 63% among NAFLD patients with an indication for liver biopsy, a number twice as high as 20 years ago.

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com. 

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late stage development, and one candidate being reviewed for regulatory approval in the United States. Zealand markets V-Go®, an all-in-one basal-bolus insulin delivery option for people with diabetes. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide therapeutics.

Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

Media Contacts

Boehringer Ingelheim

Dr. Birgit Leimer
Product Communications Manager
Boehringer Ingelheim Corporate Center GmbH
Media + PR
E-Mail: [email protected]

Zealand Pharma

David Rosen
Argot Partners
E-Mail: [email protected]

• Company celebrates one-year anniversary of acquiring Stericycle’s Environmental Solutions business (ESOL).
• More than 80-percent of Harsco’s total revenue now comes from environmental solutions and services, up from about 60-percent just three years ago.

CAMP HILL, Pa., April 13, 2021 (GLOBE NEWSWIRE) — Harsco Corporation (NYSE: HSC), a global market leading provider of environmental solutions for industrial and specialty waste streams, today announces numerous sustainability achievements for its Clean Earthdivision in 2020. Notably, Clean Earth effectively recycled 94-percent of total waste processed, over 4 million tons, including remediation of 3.27 million tons of contaminated soil.

Additional accomplishments for Clean Earth include the recycling of:

• 57,000 tons of wastewater
• 283,000 tons of hazardous waste
• 324,000 tons of dredged material
• 109,000 tons of fuel
• 14.3 million pounds of electronics
• 9.1 million pounds of lamps
• 6.6 million pounds of batteries
• 15.7 million pounds of aerosol cans
• 983,000 million pounds of ballast

“We recognize that there is still work to be done when it comes to our sustainability initiatives, but what’s true today, and what will continue to be true, is that advancing sustainability and being a more purpose-driven company will play an essential role in our future,” said David Stanton, President of Clean Earth. “We are proud of our significant environmental accomplishments and the positive impact we are making on our planet.”

Since the acquisition of Stericycle’s Environmental Solutions business (ESOL) in April 2020, the business has already made a significant impact on the industry with many new environmental solutions launched across Clean Earth. This includes a recent customized solution for the proper disposal and recycling of hand sanitizer, which resulted in 1.1 million pounds of the product being salvaged in 2020.
Because of this milestone and others, more than 80-percent of Harsco’s total revenue, inclusive of that from Clean Earth, now comes from environmental solutions and services, up from just over 60-percent three years ago. Harsco’s goal is to ultimately derive more than 90-percent of the annual revenue from environmental products and services.

“The combination of ESOL and Clean Earth has resulted in the continued success of our highly experience team utilizing unique technologies to find innovative solutions for recycling waste across the nation,” Stanton said.

Harsco will publish their 2020 Environmental, Social and Corporate Governance (ESG) report this May, highlighting the Company’s sustainability accomplishments across the globe and future plans anchoring its comprehensive sustainability strategy across all divisions, including Clean Earth.

To learn more about Clean Earth and Fullcircle™ – Clean Earth’s new Advanced Waste Lifecycle Program, visit www.cleanearthinc.com or follow Clean Earth on LinkedIn, Facebook, Twitter or Instagram.

About Harsco Corporation

Harsco Corporation (NYSE: HSC) is a global market leader providing environmental solutions for industrial and specialty waste streams, and innovative technologies for the rail sector. Based in Camp Hill, PA, the 13,000-employee company operates in more than 30 countries. Harsco’s common stock is a component of the S&P SmallCap 600 Index and the Russell 2000 Index. Additional information can be found at www.harsco.com.

About Clean Earth

Clean Earth’s vision is to create a better future for our people, partners and planet by turning specialty waste into recycling opportunities. Clean Earth is one of the largest specialty waste companies in the United States providing remediation, disposal, recycling and beneficial reuse solutions for hazardous and non-hazardous waste and contaminated materials. Headquartered in King of Prussia, Pennsylvania, it operates a network of 91 locations across the United States. As a leader in the industry, Clean Earth has the experience and capabilities to provide efficient, effective hazardous and non-hazardous waste recycling and disposal solutions. Our vast portfolio of technologies and services touches nearly every industry that generates waste including energy, infrastructure, commercial, industrial, retail and healthcare markets. To learn more, visit www.cleanearthinc.com.

Investor Contact 
David Martin
717.612.5628
[email protected]

Media Contact
Jay Cooney
717.730.3683
[email protected]

CALGARY, Alberta, April 13, 2021 (GLOBE NEWSWIRE) — Daniel Clarke, Chief Executive Officer of CSV Midstream Solutions Corp. (“CSV” or the “Company”), is pleased to announce the appointment of Rick Staples as President of CSV effective April 1, 2021. Mr. Staples will be responsible for leading the profitable operation of CSV’s current assets and executing the Company’s growth strategy, working closely with CSV’s CEO Daniel Clarke, CFO Don Rawson and the investment community.

Mr. Staples has 35 years of experience in the development and management of energy midstream businesses across North America, with strong expertise in commodity markets, profit & loss management and executive leadership. Rick joined CSV in 2017 and successfully demonstrated his invaluable leadership abilities as Chief Operating Officer during CSV’s recent period of growth. Mr. Staples is a strong supporter of Calgary’s non-profit sector, having served on the board of directors of Ronald McDonald House Calgary (Southern Alberta Pediatric Hostel Society) and as co-chair of United Way’s Energy and Engineering campaign. Rick remains an active member of his community.

To fill Rick’s previous responsibilities and to accommodate CSV’s projected growth, CSV is also pleased to announce two new executive roles. The first is the promotion of Paul Nelson to Vice President, Business Development. Mr. Nelson has over 30 years’ experience in expanding roles in midstream project development and commercial operations and has been a strong contributor to CSV’s growth over the past two years. In addition, the Company proudly announces the addition of Chris Gossen to the leadership team as Vice President, Engineering and Operations. Mr. Gossen brings over 20 years of operations and engineering experience in successively senior roles with large and small Canadian and international oil and gas producing companies.

“I am excited for the benefit that these changes will bring to our organization as we continue to grow our strategic platform and advance CSV Midstream’s leadership and expertise in Engineering and Operations” said CSV’s CEO, Daniel Clarke.

About CSV Midstream Solutions Corp.

CSV Midstream is a Calgary-based company offering a full suite of services for complete midstream solutions. With a vision to advance midstream, they provide innovative, sustainable strategies in the engineering, design, construction, operation and management of natural gas and NGL assets, including sweet and sour gas processing, liquids handling and fractionation, and gas gathering and transmission pipelines. CSV Midstream’s primary focus is the developing natural gas energy industry in the Western Canadian Sedimentary Basin.

For more information about CSV Midstream, please visit csvmidstream.com.

Contact Information for CSV Midstream

Daniel Clarke
Chief Executive Officer
t: 587.316.6900
e: [email protected]

Don Rawson
Chief Financial Officer
t: 587.316.6900
e: [email protected]