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KemPharm Participating in BIO @ JPM and Fierce JPM Week 2021 Virtual Events During “J.P. Morgan Week 2021”

CELEBRATION, Fla., Jan. 13, 2021 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the company is participating in BIO @ JPM and Fierce JPM Week 2021.  Both events are being held virtually during the month of January alongside the J.P. Morgan 39th Annual Healthcare Conference 2021.

Details of the events are as follows:

  Event: BIO @ JPM
  Date:  January 11-15, 2021
  Registration:
https://www.bio.org/events/bio-partnering-jpm/registration
     
  Event: Fierce JPM Week 2021
  Date:  January 11-13, 2021
  Registration:
https://2021outlook.fiercelifesciences.com/Register
  

During both events, members of the KemPharm management team are participating in virtual one-on-one meetings with registered attendees to discuss KemPharm’s business and highlight recent corporate achievements, as well as potential milestones, including the anticipated March 2, 2021 PDUFA date for KP415.  KP415 is KemPharm’s investigational product candidate for the treatment of ADHD.  KP415 consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.  KP415 is designed to address unmet needs with the most widely-prescribed methylphenidate ADHD treatments, including earlier onset of action and longer duration of therapy, while avoiding unnecessary spikes in d-MPH concentrations that may be associated with adverse events. 

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.

Caution Concerning Forward Looking Statements:

This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the timing of the PDUFA date and potential FDA approval of the KP415 NDA, or the potential clinical benefits of KP415 are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

KemPharm Contacts:
Jason Rando / Maureen McEnroe
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
[email protected]
[email protected]



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Ed McCaffrey and CBD Global Sciences Sign a Two-Year Endorsement Agreement with Aethics™, CBDN’s Sports Wellness CBD Infused Brand

Denver, Colorado, Jan. 13, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — CBD Global Sciences, Inc. (OTC: CBDNF) (CSE: CBDN) (Frankfurt:GS3), (“CBD Global” or the “Company”), today announced the finalization of an agreement with Ed McCaffrey, three-time Superbowl Champion and Pro Bowl Athlete, to endorse the Company’s CBD infused sports wellness brand Aethics™ (www.aethics.com). 

Ed McCaffrey, former NFL Athlete, has decided to endorse Aethics™, a CBD infused sports wellness product line that includes full spectrum tinctures, topicals, hydration and confectionary products.  Ed was extremely pleased to find a CBD infused product line geared towards athletes that focuses on mitigating pain and other ailments for the human body in an all-natural way.  Ed shared, “I was curious to hear more about the Aethics™ brand mainly because of the company’s focus on efficacy of its product line.  I have to be extremely careful to endorse products that I can be assured will impact the human body in a positive manner, my reputation counts on it.  After careful research, use of the product and study of the manufacturing process, I was convinced that Aethics™ is a product line that I can stand behind.”  He also recognized that the Colorado-based CBD company controls the quality of the CBD going into the products and it all starts at the farm in Strasburg Colorado.  With the ‘bangs and bruises’ over the many years of a successful NFL career, Ed has grown to rely on the Aethics™ products to address the issue that former athletes all experience.  “It really works, and I am so happy to introduce my colleagues and fan base to this incredible product.”

Brad Wyatt, CEO of CBD Global Sciences, shared, “I am extremely excited to have the opportunity to work with Ed on this CBD project.  He is such an incredible athlete, community leader, family man and advocate for sports wellness and health in general, it seems like a perfect fit for both Ed and Aethics.’ 

ABOUT ED MCCAFFREY

Ed McCaffrey was selected by the Giants in the third round (83rd overall) in the 1991 NFL draft. During his thirteen-year career, he won three Super Bowl rings (Super Bowl XXIX, as a San Francisco 49er and Super Bowls XXXII and XXXIII as a Denver Bronco) and made a Pro Bowl appearance in 1998.  McCaffrey met his wife, Lisa (Sime) while they both attended Stanford University.  Together, they have four sons, all of whom play football. The oldest son, Max McCaffrey, is a wide receiver who played college football at Duke. He was on the rosters of several different NFL teams from 2016–2018, and currently serves as the wide receivers coach at Northern Colorado under his father.  Christian McCaffrey was a running back for Stanford between 2014, 2015 and 2016, and was the runner-up for the 2015 Heisman Trophy.  He left school a year early after the 2016 season and was drafted with the eighth pick in the first round of the 2017 NFL Draft by the Carolina Panthers.  Dylan McCaffrey received scholarship offers from Duke, Colorado, Rutgers, LSU, Michigan, Washington, UCLA, Colorado State and Penn State. He committed to play college football at Michigan in February 2016.  The youngest son, Luke McCaffrey received an offer from Michigan and Nebraska. He committed to Nebraska in June 2018.

ABOUT CBD GLOBAL SCIENCES INC.

CBD Global Sciences, Inc., is a vertically integrated hemp-based CBD producer and branding investment vehicle which currently owns two product categories, branded under the name Aethics™ (www.aethics.com) and CANNAOIL (www.cannaoilshop.com), which include CBD Oil tinctures (liquid products), CBD capsules, CBD topicals, Hydration products and Confectionary products.  CBD Global Sciences hemp-derived CBD extracts are sold through select distributors, brick and mortar retailers, and online.

CBD Global Sciences, through its wholly owned subsidiary, Strasburg Pharms, grows and operates irrigated land in Colorado, that grows hemp with only all-natural Colorado water, soil, sun and nutrients and NEVER sprayed with pesticides or chemicals.  Our genetics are hand selected and maintained to present the best cannabinoid profile with extremely high CBD. 

For further information, please contact Bruce Nurse, Investor Relations, (888) 401-2239, [email protected]

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This news release includes certain “forward-looking statements” under applicable Canadian securities legislation. Forward-looking statements include, but are not limited to, statements with respect to future developments and the business and operations of the Corporation after the CSE listing.  Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to general business, economic, competitive, political and social uncertainties; and delay or failure to receive board, shareholder or regulatory approvals.  Readers should not place undue reliance on forward-looking statements.  The Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.



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Melco Resorts Finance Announces Proposed 5.375% Senior Notes Offering

MACAU, Jan. 13, 2021 (GLOBE NEWSWIRE) — Melco Resorts Finance Limited (“Melco Resorts Finance”) announces that it proposes to conduct an international offering of 5.375% senior notes due 2029 (the “Additional Notes”), the net proceeds from which, together with cash on hand if applicable, will be used for repayment of the principal amount drawn under the revolving credit facility under the senior facilities agreement entered into by MCO Nominee One Limited, a subsidiary of Melco Resorts Finance, on April 29, 2020, together with accrued interest and associated costs, and any remaining balance for general corporate purposes. Melco Resorts Finance is a wholly-owned subsidiary of Melco Resorts & Entertainment Limited (“Melco”).

The proposed Additional Notes will be issued under the indenture, dated December 4, 2019 (the “Indenture”), pursuant to which Melco Resorts Finance issued US$900 million aggregate principal amount of 5.375% senior notes due 2029 (the “Original Notes”). The Additional Notes will constitute additional notes under the Indenture and will be issued on the same terms and conditions (other than the issue date and issue price) and will be consolidated and form a single series with the Original Notes. Melco will not be a guarantor of the Additional Notes.

The issue price of the Additional Notes will be determined at the time of pricing of the offering. Completion of the proposed offering of the Additional Notes is subject to market conditions and investor interest. As no binding agreement in relation to the proposed offering of the Additional Notes has been entered into as at the date of this press release, the proposed Additional Notes may or may not be issued.

The Additional Notes are being proposed to be offered and sold in the United States to qualified institutional buyers pursuant to Rule 144A under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and outside of the United States in reliance on Regulation S under the Securities Act. The proposed Additional Notes will not be registered under the Securities Act or under the securities laws of any state or other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state laws. Melco Resorts Finance does not intend to register any portion of the offering of the proposed Additional Notes in the United States.

Nothing in this press release constitutes an offer to buy, or a solicitation of an offer to sell, securities in the United States or any other jurisdiction in which such offer or solicitation would be unlawful. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act.

Safe Harbor Statement

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Melco Resorts Finance’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. These factors include, but are not limited to, (i) the global pandemic of COVID-19, caused by a novel strain of the coronavirus, and the continued impact of its consequences on our business, or industry and the global economy, (ii) growth of the gaming market and visitations in Macau, (iii) capital and credit market volatility, (iv) local and global economic conditions, (v) our anticipated growth strategies, (vi) gaming authority and other governmental approvals and regulations, and (vii) our future business development, results of operations and financial condition. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. All information provided in this press release is as of the date of this press release, and Melco Resorts Finance undertakes no duty to update such information, except as required under applicable law.

For investment community, please contact:

Richard Huang
Director, Investor Relations
Tel: +852 2598 3619
Email: [email protected]

For media enquiries, please contact:

Chimmy Leung
Executive Director, Corporate Communications
Tel: +852 3151 3765
Email: [email protected] 



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Colgate-Palmolive, Harvard School of Dental Medicine Establish Scholarship to Support Underrepresented Minority Dental Students

Colgate-Palmolive, Harvard School of Dental Medicine Establish Scholarship to Support Underrepresented Minority Dental Students

Company Donation Makes It Possible for Freeman, Grant, Franklin Scholarship to Begin This Year

NEW YORK–(BUSINESS WIRE)–
Colgate-Palmolive Company and the Harvard School of Dental Medicine (HSDM) today announced a major gift that will initiate the endowed Freeman, Grant, Franklin Scholarship, which supports students from underrepresented, minority groups to pursue their Doctor of Dental Medicine (DMD) degree.

The Freeman, Grant, Franklin Scholarship pays tribute to prominent African American figures in HSDM’s history: Robert Tanner Freeman, George Franklin Grant, and Dolores Mercedes Franklin. Freeman in 1869 was the first African American in the United States to graduate from a dental school; Grant became the first African American faculty member of Harvard University as well as the Harvard School of Dental Medicine in 1884. Franklin was the first African American woman to graduate from HSDM.

Colgate’s contribution of $210,000 has enabled the scholarship’s activation. The first scholarship will be awarded to a student beginning in the 2021 academic year and continue on an annual basis, helping HSDM to admit the best and brightest students regardless of their financial means.

“Increasing diversity among the dental profession is critical to our goal of realizing a cavity-free future for all,” said Noel Wallace, Chairman, President, and Chief Executive Officer of Colgate-Palmolive. “With a brand that is in more homes than any other, Colgate understands our opportunity – and responsibility – to make oral health more equitable and accessible around the world. From the products we develop to our longstanding Colgate Bright Smiles, Bright Futures community program to scholarships like this, we are determined to build a healthier and brighter future for people everywhere.”

Despite representing more than one-third of the U.S. population, Black and Hispanic dentists and those who identify as another race or ethnicity only represent a combined nine percent of professionals in the industry, according to the American Dental Association (ADA).

“The Harvard School of Dental Medicine has a long legacy of embracing diversity. Colgate’s generous support will help further our ethos to promote greater diversity, inclusion and belonging in dental education and in oral health research,” said William Giannobile, Dean of the Harvard School of Dental Medicine. “It enables us to take another important step toward providing the much needed financial resources for our under-represented students to pursue their dreams in oral healthcare delivery.”

Colgate is dedicated to serving as a leader in global diversity, equity, and inclusion in the consumer packaged goods industry and in the communities the company serves around the world. As an ally for positive change for underserved and underrepresented groups, the Company is committed to the continued support of its partner organizations and to taking actions that champion a more equitable future. More information about Colgate’s commitment to the advancement of DE&I is available here.

About Colgate-Palmolive

Colgate-Palmolive Company is a caring, innovative growth company reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition and reaching more than 200 countries and territories, Colgate teams are developing and selling health and hygiene products and pet nutrition offerings essential to society through brands such as Colgate, Palmolive, elmex, meridol, Tom’s of Maine, hello, Sorriso, Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Filorga, eltaMD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet. Colgate seeks to deliver sustainable, profitable growth and superior shareholder returns and to provide Colgate people with an innovative and inclusive work environment. Colgate does this by developing and selling products globally that make people’s lives healthier and more enjoyable and by embracing its sustainability, diversity, equity and inclusion and social responsibility strategies across the organization. For more information about Colgate’s global business, its efforts to improve the oral health of children through its Bright Smiles, Bright Futures program and how the Company is building a future to smile about, visit www.colgatepalmolive.com. CL-C

About Harvard School of Dental Medicine

Located in the heart of Boston’s Longwood Medical Area, Harvard School of Dental Medicine (HSDM) ranks as one of the preeminent schools of dental medicine in the country. HSDM educates clinicians, educators, researchers, and leaders in the profession; boasts core strengths in musculoskeletal-disease research; and offers students public health opportunities in local communities and across the globe.

In a unique educational model in which oral health and primary care are inextricably linked, HSDM pre-doctoral students (DMD students) study clinical medicine with Harvard medical students and then pursue additional years of intensive, interdisciplinary clinical science education at HSDM and affiliated sites. Advanced graduate students, who work toward a doctor of medical sciences (DMSc) or master of medical sciences (MMSc) degree and/or a specialty certificate, also draw upon the richness of the educational facilities and research institutes of the broader Harvard community and Greater Boston area. HSDM is the only school of Harvard University that offers direct patient care, with the Harvard Dental Center welcoming more than 25,000 patients for over 57,000 dental visits every year. HSDM graduates make their mark in prevention, discovery, and practice as they work to improve the health and well-being of local and global populations.

Robert Goodfellow

Colgate-Palmolive Company

646-277-1218

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Philanthropy Supermarket Training Consumer Convenience Store Continuing University Education Dental Foundation Retail Other Consumer Health

MEDIA:

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INTRUSION Successfully Completes Beta Testing of its Newest Cybersecurity Solution, Shield; Announces General Availability

Shield stopped more than 77 million threats, protecting businesses from serious cyberattacks

PLANO, Texas, Jan. 13, 2021 (GLOBE NEWSWIRE) — With recent cyberwarfare attacks being carried out against the United States, the general availability of the new cybersecurity solution from INTRUSION Inc. (NASDAQ: INTZ), Shield™, comes at a time when it’s never been more important to expertly protect U.S. organizations – public and private, large to small. Shield is the first solution for the enterprise that uses artificial intelligence (AI) to not only identify malicious activity within a network but to kill the connection, thus stopping those threats in their tracks, protecting companies from debilitating cybercrime.

“This product just does not exist in the market today and is sorely needed,” said Aaron, chief information security corporate officer (CISCO) for B. Riley Financial, who participated in beta testing.

Beta testing of INTRUSION Shield confirmed the solution’s efficacy by stopping a total of 77,539,801 cyberthreats from 805,110 uniquely malicious entities attempting to breach 13 companies that participated in the 90-day beta program. Shield was able to continuously protect these companies from ransomware, denial of service attacks, malware, data theft, phishing and more. In fact, analysis by INTRUSION also concluded that Shield would have defended against the Sunburst malware that was at the heart of the recent cyberattacks involving SolarWinds and FireEye, which impacted many government agencies and 18,000 SolarWinds customers.

“With the high-risk patterns we’ve incorporated into the rule set that feeds our AI, along with the reputation and suspicious activity that it searches for while monitoring all traffic in and out of a network, we can confidently say Shield would have protected our customers where clearly other security approaches failed,” said Jack B. Blount, President and CEO of INTRUSION. “The malware had been living on the SolarWinds network for at least nine months undetected – it got past firewalls and many other cybersecurity products. This is all the more reason companies need a multi-layered approach to cybersecurity, and specifically one that stops threats in real-time to protect them from the damage cybercriminals can cause over time.”

All companies participating in the beta program have made the decision to move forward with Shield in production.

“The Shield solution has shown us that virtually every network is already infected, and front-end protection is not possible. The understanding that networks are already compromised and that the only means of protection is to monitor and restrict outgoing traffic is the breakthrough of the Shield philosophy,” said Richard, President of NovaTech.

Additionally, false positive security alerts – where legitimate traffic is identified as a threat – are a significant problem among cybersecurity solutions available today, with Ponemon Institute reporting that most cybersecurity companies see mistaken alerts happening 33% of the time. Cybersecurity professionals spend hundreds of hours investigating these alerts only to determine ultimately that there was no threat. Beta testing for Shield showed a median false positive rate of 0.001% of all traffic, far surpassing other solutions on the market and allowing businesses to run uninterrupted. Multiple beta customers were happy to report they saw zero false positives using Shield.

“Businesses simply can’t afford to keep using the same cybersecurity solutions that aren’t adequately protecting them,” said Blount. “As shown by our beta testing results, Shield offers the best new layer of protection to keep businesses of all sizes safe from the cybercrime that causes hundreds of them to go out of business completely.”

“The ease and instant protection of Shield has been great,” said Michael, Portfolio Manager for Bard Associates. “It’s so simple to implement and run, yet highly effective.”


Shield
 is the only real-time, AI-based cybersecurity solution that utilizes the world’s largest Big Data Cloud of databases built upon 25 years of tracking and researching cybercrime activities. The solution’s AI uses this information to kill known threats, as well as to learn the behaviors of both safe and malicious network traffic. It then works from the inside out – every millisecond of every day – identifying all attempted malware connections coming into, living on, and going out of a network, and immediately stopping them without human intervention.


Shield
 is now available at a low cost of $20 per seat ($2,000 minimum) per month with no annual contract required. Visit https://www.intrusion.com/shield for more information.

INTRUSION will be releasing case studies from Shield beta testing in the coming weeks.

About INTRUSION Inc.

INTRUSION, Inc. is a global provider of entity identification, high speed data mining, cybercrime and advanced persistent threat detection solutions. INTRUSION’s family of solutions includes Shield™, a combination of plug-n-play hardware, software, global data, and real-time Artificial Intelligence (AI) services that provide organizations with the most robust cybersecurity defense possible, TraceCop™ for identity discovery and disclosure, and Savant™ for network data mining and advanced persistent threat detection. INTRUSION’s solutions help protect critical information assets by quickly detecting, protecting, analyzing and reporting attacks or misuse of classified, private and regulated information for government and enterprise networks. For more information, please visit www.intrusion.com.

Cautionary Statement Regarding Forward Looking Information

This release may contain certain forward-looking statements, including, without limitations, statements about the performance of protections provided by our Shield products, or other statements which reflect management’s expectations regarding future events and operating performance and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties, including, the risk that our Shield product does not perform as anticipated. These statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, risks that we have detailed in the Company’s most recent reports on Form 10-K and Form 10-Q, particularly under the heading “Risk Factors.”

Company & Media Contact
Julia Kramer
[email protected]
P: 972-301-3635



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Infosys to Onboard Award-Winning Experience Design Agency, Carter Digital

Strengthens Infosys’ creative digital capabilities across Australia

PR Newswire

BENGALURU, India and MELBOURNE, Australia, Jan. 13, 2021 /PRNewswire/ — Infosys (NYSE: INFY), a global leader in next-generation digital services and consulting, today announced a definitive agreement to purchase assets and onboard employees of Carter Digital, one of Australia’s leading and award-winning experience design agencies. This asset takeover strengthens Infosys’ global design and experience offerings, demonstrates its continued commitment in bringing innovative thinking, talent and creativity to its clients, and provide effective global digital solutions.

Infosys_Logo

Carter brings to Infosys, experts in human centered design, experiential, enhanced digital transformation, customer interaction expertise, and will also cement WONGDOODY, an Infosys brand, into the Australasian market.The agency is known for its holistic approach and ‘people first, design later’ mantra, delivering services to connect digital to physical experiences in the consumer, commerce, technical and corporate environments, backed with data analysis, analytics, and creative expertise, to drive compelling, purposeful outcomes.

With services that include business and creative strategy, research and insights, branded commerce and digital product development, user and customer experiences, interaction, experiential and creative design, consumer and product design, Carter delivers enriched, purpose-led experience for brands across arts, culture, education, tourism, events, start-ups and healthcare.

Together with Infosys’ earlier acquisition of WONGDOODY that offers creative and marketing services, Carter brings complementary capabilities to help global CMOs and businesses thrive in a digital commerce world.  As part of Infosys’ global design and experience offering, Carter Digital will be rebranded as WONGDOODY and join its network of studios across Seattle, Los Angeles, New York, Providence, Houston, and London, as well as design hubs in five Indian cities.


Andrew Groth, Senior Vice President and Region Head for Australia and New Zealand, said, “Australia is a strategic market for Infosys and the company has enjoyed strong and consistent growth serving marquee clients across a range of industries from telecom and financial services, to utilities and the public sector. As digital experience becomes a critical differentiator in most enterprise transformations, the addition of Carter’s capabilities reaffirms our commitment to help clients navigate their digital priorities with a complete end-to-end offering.”


Ben Weiner, CEO, WONGDOODY, an Infosys company, added, “In Carter, we have found kindred spirits who align with the cultures of both WONGDOODY and Infosys. We are very excited to bring their capabilities to Infosys’ clients in the market where the opportunity to add layers of digital strategy, customer experience, and design is significant and compelling. We are excited to welcome Carter Digital to the Infosys family”

“Carrying the WONGDOODY flag into our region provides us the ability to turbo charge our delivery. This, along with the backing of Infosys, means we now have the instant depth and scalability to meet the growing needs and expectations of our current and future clients,” said Paul Beardsell, Founder & Managing Director, Carter Digital.


James Noble, Founder & Chief Creative Officer of Carter Digital added, “We’re excited to be joining WONGDOODY, an Infosys company. Being a like-minded, internationally recognised human experience and brand engagement agency creates enormous opportunities for us in the Australasian market. This enable us to further our industry-leading work, connecting us to new capabilities, and enhancing our partner’s success.”

This is an asset purchase and the transaction is expected to close during the fourth quarter of fiscal 2021, subject to customary closing conditions.

About Carter Digital

Putting people ahead of everything else, Carter delivers human-centric, data driven outcomes to transform the way customers interact with businesses, in a rapidly changing digital world. Delivering experiences to surprise and delight the people using them, they enable clients to exceed audience needs, grow market share and deepen engagements. Carter have achieved sustained success in a world where technology, expectations and adapts to meet customer behaviours.

Winner of numerous industry accolades and awards on behalf of their clients since 2010, is an acknowledgement of the consistent results Carter deliver.

About WONGDOODY, an Infosys company

WONGDOODY is an award-winning creative agency and the global experience-and-design platform for Infosys. The company is recognized for branding, retail, and consumer insights. With offices in Seattle, New York, Los Angeles, Providence, and across the globe; WONGDOODY clients have included Amazon, Honda, and a wide range of Fortune 500 companies.

About Infosys

Infosys is a global leader in next-generation digital services and consulting. We enable clients in 46 countries to navigate their digital transformation. With nearly four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.

Visit www.infosys.com to see how Infosys (NYSE: INFY) can help your enterprise navigate your next.


Safe Harbor

Certain statements in this release concerning our future growth prospects, financial expectations and plans for navigating the COVID-19 impact on our employees, clients and stakeholders are forward-looking statements intended to qualify for the ‘safe harbor’ under the Private Securities Litigation Reform Act of 1995, which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding COVID-19 and the effects of government and other measures seeking to contain its spread, risks related to an economic downturn or recession in India, the United States and other countries around the world, changes in political, business, and economic conditions, fluctuations in earnings, fluctuations in foreign exchange rates, our ability to manage growth, intense competition in IT services including those factors which may affect our cost advantage, wage increases in India, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, restrictions on immigration, industry segment concentration, our ability to manage our international operations, reduced demand for technology in our key focus areas, disruptions in telecommunication networks or system failures, our ability to successfully complete and integrate potential acquisitions, liability for damages on our service contracts, the success of the companies in which Infosys has made strategic investments, withdrawal or expiration of governmental fiscal incentives, political instability and regional conflicts, legal restrictions on raising capital or acquiring companies outside India, unauthorized use of our intellectual property and general economic conditions affecting our industry and the outcome of pending litigation and government investigation. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our Annual Report on Form 20-F for the fiscal year ended March 31, 2020. These filings are available at www.sec.gov. Infosys may, from time to time, make additional written and oral forward-looking statements, including statements contained in the Company’s filings with the Securities and Exchange Commission and our reports to shareholders. The Company does not undertake to update any forward-looking statements that may be made from time to time by or on behalf of the Company unless it is required by law.

Cision View original content:http://www.prnewswire.com/news-releases/infosys-to-onboard-award-winning-experience-design-agency-carter-digital-301207448.html

SOURCE Infosys

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Edwards Lifesciences To Host Earnings Conference Call On January 27, 2021

PR Newswire

IRVINE, Calif., Jan. 13, 2021 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) plans to announce its operating results for the quarter ended December 31, 2020 after the market closes on Wednesday, January 27, 2021, and will host a conference call at 5:00 p.m. ET that day to discuss those results.

To participate in the conference call, dial (877) 704-2848 or (201) 389-0893.  For 72 hours following the call, an audio replay can be accessed by dialing (877) 660-6853 or (201) 612-7415 and using conference number 13714408.  The call will also be available via live or archived webcast on the “Investor Relations” section of the Edwards website at ir.edwards.com.


About Edwards Lifesciences

Edwards Lifesciences, is the global leader of patient-focused innovations for structural heart disease and critical care monitoring.  We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.

Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)

Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)

Marinus is moving towards a pre-NDA meeting, targeted for the end of Q1, in support of NDA submission by the end of Q2

RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has received a positive response from the U.S. Food and Drug Administration (FDA) that the efficacy and safety data resulting from the company’s pivotal Phase 3 Marigold Study on the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD) appear sufficient to support the filing of a New Drug Application (NDA). Adequacy of these data to support an approval of ganaxolone for the proposed indication will be a matter of future FDA review.

CDD is a rare, genetic epilepsy with refractory seizures. Marinus provided the data to the FDA in a briefing document meant to support a Type C meeting, and the FDA provided written preliminary comments in response. Based on this feedback, Marinus is targeting a pre-NDA meeting by the end of Q1 to support submission.

“We are pleased with the FDA’s assessment of the sufficiency of the efficacy and safety data from one Phase 3 clinical trial to support an NDA filing,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus. “We remain on track to submit the NDA for use of ganaxolone in CDD for FDA review by mid-2021 and look forward to continued advancement of ganaxolone as the first potential FDA approved treatment specifically indicated in patients diagnosed with CDD.”

In September, Marinus reported positive topline data from the Phase 3 Marigold Study, the first double-blind placebo-controlled trial to provide evidence of efficacy in CDD and the first Phase 3 trial to examine three times a day dosing of ganaxolone in pediatric patients.

In the Phase 3 Marigold trial, patients treated with ganaxolone showed a significant 32.2% median reduction in 28-day major motor seizure frequency, compared to a 4.0% reduction for those receiving the placebo, achieving the trial’s primary endpoint (p=0.002). In this trial, ganaxolone was generally well tolerated with a safety profile consistent with previous clinical trials, with the most frequent adverse event being somnolence.

“We see continued progress in our other development programs,” continued Dr. Braunstein. “Marinus continues to initiate new sites to participate in the Phase 3 clinical trial of IV ganaxolone for the treatment of Refractory Status Epilepticus (RSE) or RAISE trial. While the COVID-19 pandemic is lengthening the time for new trial sites to open for enrollment, we do not anticipate this having major implications on the ultimate timing of trial results.”

“The Phase 2 Violet Study, evaluating both three times a day dosing of ganaxolone and the role of allopregnanolone sulfate as a biomarker in PCDH19-related epilepsy remains on track. In March, we plan to provide an update on this program,” said Dr. Braunstein. “Additionally, we expect to report top line data from our Phase 2 Tuberous Sclerosis Complex trial by late Q2.”

About CDKL5 Deficiency Disorder

CDKL5 deficiency disorder (CDD) is a serious and rare genetic disorder that is caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. CDD is characterized by early-onset, difficult-to-control seizures and severe neuro-developmental impairment. Most children affected by CDD cannot walk, talk, or feed themselves. Currently, there are no therapies approved specifically for CDD.

About Ganaxolone

Ganaxolone, a positive allosteric modulator of GABAA receptors, is being developed in intravenous and oral formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Unlike benzodiazepines, ganaxolone exhibits antiseizure, antidepressant and anti-anxiety activity via its effects on synaptic and extrasynaptic GABAA receptors. More than 1,600 study participants, both adults and children, have received ganaxolone at therapeutically relevant dose levels and treatment regimens for up to four years.

About Marinus Pharmaceuticals

Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders. Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects. Ganaxolone is being developed in IV and oral dose formulations intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus recently completed the first ever Phase 3 pivotal trial in children with CDKL5 deficiency disorder and is conducting a Phase 2 trial in tuberous sclerosis complex, as well as a Phase 2 biomarker-driven proof-of-concept trial in PCDH19-related epilepsy. The company is initiating a Phase 3 trial in status epilepticus.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “believe”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our clinical development plans for ganaxolone; our plans to have a pre-NDA meeting with FDA for submission of an NDA for use of ganaxolone in CDKL5 Deficiency Disorder (CDD) by the end of first quarter 2021; our expectations to file an NDA for ganaxolone in CDD by end of second quarter 2021; our ability to receive FDA approval of ganaxolone in CDD; our plan to provide an update on our Phase 2 Violet Study in March 2021; our expectations that COVID-19 will not have major implications on the ultimate timing of trial results for our RAISE Phase 3 clinical trial in Refractory Status Epilepticus; our expectation to report top line data from our Phase 2 Tuberous Sclerosis Complex trial by late second quarter 2021. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; clinical trial results may not support further development in a specified indication or at all; actions or advice of the U.S. Food and Drug Administration may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the interpretation of clinical trial results and the ability of clinical trial results to support regulatory approval; our ability to obtain and maintain regulatory approval for our product candidate; delays, interruptions or failures in the manufacture and supply of our product candidate; our ability to raise additional capital; the effect of the COVID-19 pandemic on our business, the medical community and the global economy; and the availability or potential availability of alternative products or treatments for conditions targeted by us that could affect the availability or commercial potential of our product candidate. Marinus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Marinus has made with the Securities and Exchange Commission.

Sasha Damouni Ellis

Vice President, Investor Relations & Corporate Communications

Marinus Pharmaceuticals, Inc.

484-253-6792

[email protected]

KEYWORDS: Pennsylvania United States North America

INDUSTRY KEYWORDS: Research Mental Health FDA Genetics Clinical Trials Biotechnology General Health Pharmaceutical Health Science

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Southern Company joins Apple in announcing launch of new digital learning hub, global headquarters for innovation for HBCUs

PR Newswire

ATLANTA, Jan. 13, 2021 /PRNewswire/ — Southern Company and Apple joined educators and community stakeholders today to announce a partnership to launch the Propel Center, a new digital learning hub, business incubator, and global innovation headquarters in Atlanta, Georgia for students of historically black colleges and universities (HBCUs).

Both Apple and Southern Company are founding partners, with the Southern Company Foundation and Apple each contributing $25 million to this effort.

“We know inequities exist in our society, and it’s up to each of us to be more intentional in our efforts to make a difference and bridge the gap,” said Thomas A. Fanning, chairman, president and CEO of Southern Company. “We know more must be done, and the establishment of the Propel Center is another important demonstration of Southern Company fulfilling our commitment to move our communities to a more equitable future. Partnering with Apple in this initiative is an exciting way to connect future leaders with these critical resources.”

“We’re proud to partner with Southern Company on this groundbreaking new project to build a global hub for innovation and learning for the entire HBCU community,” said Lisa Jackson, Apple vice president of environment, policy, and social initiatives. “This important effort builds on our long-standing collaboration to advance educational equity, and we are thrilled to be working together to help HBCU faculty create best-in-class curriculum and ensure their students have access to cutting-edge skills and opportunities.”

The $25 million investment from the Southern Company Foundation will help grow Black entrepreneurship and provide much-needed technology resources to the workforce of the future. This commitment is part of the $50 million multi-year initiative Southern Company and its subsidiaries announced in 2020 to provide scholarships, internships, leadership development, access to technology and innovation to support career readiness for students attending select HBCUs within the Southern Company system’s service footprint in Alabama, Mississippi, Georgia, North Carolina, Tennessee, and Virginia.

“We are incredibly encouraged by the future possibilities presented through our support of HBCUs,” said Chris Womack, president of Georgia Power, a subsidiary of Southern Company. “By investing in better outcomes, we create new opportunities for the students of today to become the leaders of a more prosperous tomorrow.”

Propel is both a physical and virtual campus that is designed to provide HBCUs with shared resources to support their work of preparing leaders to improve our world. Via a physical campus and digital learning tools, students from 100-plus HBCUs will be able to connect with the brightest minds in the world, through one-of-a-kind global opportunities. The students will also be able to connect with each other — a key component as they become more civic-minded leaders and entrepreneurs of tomorrow.

“Tech jobs offer lucrative salaries and among the best opportunities for growth, yet the workforce in the nation’s top firms still does not reflect the country’s diverse population,” said Dr. David A. Thomas, president of Morehouse College. “Black and Hispanic professionals continue to be underrepresented in STEM (Science, Technology, Engineering, and Math) careers. What students need are more opportunities at the college level to show and grow their skills in coding, programming, and data analysis in partnership with industry leaders. Apple and Southern Company are committed to developing the talent found at HBCUs and are committing resources to help improve diversity in STEM.”

The physical campus will be located in Atlanta at the Atlanta University Center, a consortium made up of Clark Atlanta University, Morehouse College, Morehouse School of Medicine, Morris Brown, and Spelman College. Southern Company will serve as the energy partner for the construction of the building, ensuring it is sustainable and environmentally-friendly.

“The Propel Center will be a tremendous asset to Atlanta’s thriving HBCU community and will advance the mission of these institutions in the United States, and around the world,” said Atlanta Mayor Keisha Lance Bottoms. “Thank you to Apple and Southern Company for investing in our youth and our communities. We are honored to join you in this monumental effort.”

The Propel Center continues the work that was established by Southern Company subsidiary Alabama Power and Apple in February 2020 with the launch of Ed Farm, an education initiative that aims to equip educators and communities in Alabama with innovative tools and strategies that support active learning for all students. The goals of Ed Farm: increase educational equity, improve learning outcomes through technology, and prepare the future tech workforce.

Anthony Oni, a Southern Company Gas executive who serves as the founder and chairman of Ed Farm, designed the Propel initiative to advance collaboration and innovation at HBCUs. He will continue to work on the project going forward, actively engaging with academic and institutional partners.

“These investments are critical as we begin to truly scale Black innovation ecosystems,” said Oni, vice president, Southern Company Gas. “By leveraging technology and partnerships to connect students with unique learning opportunities, we can lift up the talent that already exists at these institutions of higher learning and accelerate their development. In doing so, we will have a hand in shaping the workforce of the future — and the leaders of tomorrow.”

For updates, and to register your interest in participating, visit www.PropelCenter.org.

About Southern Company
Southern Company (NYSE: SO) is a leading energy company serving 9 million customers through its subsidiaries. The company provides clean, safe, reliable and affordable energy through electric operating companies in three states, natural gas distribution companies in four states, a competitive generation company serving wholesale customers across America, a leading distributed energy infrastructure company, a fiber optics network and telecommunications services. Southern Company brands are known for excellent customer service, high reliability and affordable prices below the national average. For more than a century, we have been building the future of energy and developing the full portfolio of energy resources, including carbon-free nuclear, advanced carbon capture technologies, natural gas, renewables, energy efficiency and storage technology. Through an industry-leading commitment to innovation and a low-carbon future, Southern Company and its subsidiaries develop the customized energy solutions our customers and communities require to drive growth and prosperity. Our uncompromising values ensure we put the needs of those we serve at the center of everything we do and govern our business to the benefit of our world. Our corporate culture and hiring practices have been recognized nationally by the U.S. Department of Defense, G.I. Jobs magazine, DiversityInc, Black Enterprise, Fortune’s “World’s Most Admired Companies” list, Forbes and the Women’s Choice Award. To learn more, visit www.southerncompany.com.

 

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Taysha Gene Therapies and UT Southwestern Medical Center Launch Innovation Fund to Accelerate Advancement of AAV Gene Therapies for Monogenic Diseases of the Central Nervous System

Taysha Gene Therapies and UT Southwestern Medical Center Launch Innovation Fund to Accelerate Advancement of AAV Gene Therapies for Monogenic Diseases of the Central Nervous System

Expanded collaboration to support discovery of novel gene therapy candidates and next-generation technologies in new disease areas

Taysha to have an exclusive option on discovery programs and intellectual property arising from research conducted under the agreement

DALLAS–(BUSINESS WIRE)–
Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS) in both rare and large patient populations, and UT Southwestern Medical Center (UTSW) today announced the launch of an innovation fund to discover and develop novel gene therapy candidates and next-generation technologies for monogenic diseases of the CNS. This expanded partnership will support UTSW’s discovery efforts to facilitate the translation of promising discoveries from bench to clinic. Taysha will have an exclusive option on new programs and intellectual property associated with, and arising from, the research conducted under this agreement.

A team of researchers from the gene therapy program at UT Southwestern will explore novel gene therapy targets in new disease areas and create next-generation gene therapy technology platforms to address some of the current limitations of this modality.

“We are excited to expand our alliance with UTSW to accelerate the discovery and development of novel gene therapy candidates and next-generation technologies for patients with monogenic CNS diseases,” said RA Session II, President, Founder and CEO of Taysha. “We believe that the combination of UTSW’s translational research expertise in gene therapy and strong track record of innovation and our experience in drug development and GMP manufacturing will create opportunities to reach more patients with unmet medical needs. Our relationship with the UTSW gene therapy program has produced over 18 novel product candidates, including TSHA-101 in GM2 gangliosidosis and TSHA-118 in CLN1, which are currently in clinical development. We are pleased by the significant progress our partnership has achieved and are excited to build on that foundation and momentum to bring additional compelling innovation to the clinic.”

About The University of Texas Southwestern Medical Center

UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes and includes 23 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 13 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,500 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in about 80 specialties to more than 105,000 hospitalized patients, nearly 370,000 emergency room cases, and oversee approximately 3 million outpatient visits a year.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com.

Company Contact:

Kimberly Lee, D.O.

SVP, Corporate Communications and Investor Relations

Taysha Gene Therapies

[email protected]

Media Contact:

Carolyn Hawley

Canale Communications

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: University Education Health General Health Public Relations/Investor Relations Communications Other Science Medical Devices Research Genetics Science

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