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Merck Animal Health receives positive CVMP opinion for an injectable formulation of BRAVECTO® (Fluralaner) for use in dogs

RAHWAY, N.J. — (BUSINESS WIRE) — Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for BRAVECTO® (fluralaner) 150 mg/ml powder and solvent for suspension for injection for dogs.

 

The CVMP recommends the product for approval for the treatment and persistent killing of fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, Ixodes hexagonus, and Dermacentor reticulatus) for 12 months. If the European Commission (EC) adopts the recommendation, this injectable formulation of BRAVECTO can be used by or under the supervision of a veterinarian and for administration to dogs and puppies six months of age and older.

 

“Since our initial launch of BRAVECTO nearly a decade ago, Merck Animal Health has been committed to bringing innovations to our customers that protect pets longer from flea and tick infestations and the associated health risks,” said Rick DeLuca, executive vice president and president, Merck Animal Health. “With today’s positive opinion of this injectable formulation of BRAVECTO, the first and only once-yearly injectable flea and tick medication, pet owners are one step closer to a new, convenient option to help ensure year-round comprehensive protection from fleas and ticks without the need for administering multiple doses of medication.”

 

Certain ticks can transmit serious infections in dogs. Many ticks can live in both warm and cold temperatures and are known to feed on dogs,1 making continuous year-round protection of utmost importance for pets and people.

 

“Though people often think of flea and tick season during the summer months, studies have shown that while fleas and ticks are most active from early spring through the fall, they can be a threat year-round,” said Holger Lehmann, vice president, Pharmaceutical Research & Development, Merck Animal Health. “If approved, a once-yearly dosing of BRAVECTO injectable can provide a long duration of protection, simplifying care for both pet owners and veterinarians. This promotes compliance and helps ensure continuous protection.”

 

Based on the CVMP’s recommendation, the EC is expected to issue a decision for marketing authorization in the European Union (EU) during the first quarter of 2024.

 

About BRAVECTO® (fluralaner)

Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 300 million doses distributed in more than 100 countries. BRAVECTO is available in a variety of formulations, including products for both dogs and cats.

 

The flea and tick life cycles can also last for months and missed doses of monthly treatments may leave gaps in protection.

 

Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet parents, fleas and ticks are not only active in the spring and summer months, but they are a year-round risk.

 

Fleas and ticks can easily infest dogs and cats. They also can bite and pose health risks to human family members whether at home or outdoors. Ticks can spread serious diseases including rickettsiosis, anaplasmosis and borreliosis (Lyme disease), while fleas are the most common external parasite found on pets and can transmit bartonellosis (Cat Scratch disease) and tapeworms.

 

About Merck Animal Health

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of Healthier Animals®, Merck Animal Health offers veterinarians, farmers, producers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (Formerly Twitter) and Instagram.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

References

[1] Probst J, Springer A, Topp AK, Bröker M, Williams H, Dautel H, Kahl O, Strube C. Winter activity of questing ticks (Ixodes ricinus and Dermacentor reticulatus) in Germany− Evidence from quasi-natural tick plots, field studies and a tick submission study. Ticks and Tick-borne Diseases. 2023 Nov 1;14(6):102225.

Contacts

Media:

Kim Gorode

(973) 255-8904

Kim.Gorode@merck.com

Investor:

Peter Dannenbaum

(732) 594-1579

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NICE Actimize recognized as Category Leader in the Chartis KYC Data and Solutions 2023 Market Update and Vendor Landscape Report

Measured across five unique solution functions, NICE Actimize scored highly in KYC risk scoring capabilities as well as reporting and dashboarding, and customer onboarding

 

 

HOBOKEN, N.J. — (BUSINESS WIRE) — #NICE—NICE Actimize, a NICE (NASDAQ: NICE) business, has been recognized by Chartis Research as a Category Leader in KYC solutions in its recently released KYC Data and Solutions 2023 Market Update and Vendor Landscape Report. The Chartis KYC RiskTech Quadrant® rated vendors across Market Potential and Completeness of Offering criteria which included 35 vendors of KYC solutions featured in this report. Chartis Research, part of Infopro Digital, is a leading provider of research and analysis on the global market for risk technology.

NICE Actimize achieved high scores across various parameters, including reporting and dashboarding, KYC risk scoring, customer profile enrichment with additional data, customer onboarding and maintenance. Most notably, NICE Actimize achieved a “four-star” rating for the category of KYC risk scoring. Other characteristics influencing the ranking position were market potential attributes, including customer satisfaction, market penetration, growth strategy, business model, and financials.

 

“NICE Actimize has continued to build out its KYC offering across cloud and on-premise deployments, developing its simulation and model and entity risk capabilities,” said Ahmad Kataf, Senior Research Specialist at Chartis Research. “Its strong partnership strategy reinforces its position as a hub for a flexible financial crime compliance marketplace, and it has also demonstrated continued growth on top of its already strong market penetration. All these factors are reflected in its category leader positioning in our KYC Solutions quadrant.”

 

“NICE Actimize’s AI-powered KYC/CDD solutions manage critical compliance challenges while providing complete customer lifecycle coverage without compromising customer experience,” said Craig Costigan, CEO, NICE Actimize, “As our financial services organizations place stronger emphasis on determining risk, our entity risk approach offers an unmatched ability to access true and transparent business intelligence around customers and entities while managing critical compliance challenges.”

 

In addition to offering complete customer lifecycle risk coverage, NICE Actimize’s next-generation KYC/CDD solution includes integrated data intelligence, identity resolution, extensive out-of-the-box risk models, dynamic segmentation and risk scoring, simulation, and full auditability to help organizations fully understand their customers, their customers’ connections, and any associated risks.

 

NICE Actimize was recently positioned number fifteen in Chartis’ comprehensive list of top 100 global risk and compliance technology vendors in the 2024 Chartis RiskTech100 report.

 

For further information on NICE Actimize solutions for Know Your Customer / KYC solutions, including white papers and e-books, please visit its web site here.

 

About Chartis

Chartis Research is the leading provider of research and analysis on the global market for risk technology. It is part of Infopro Digital, which owns market-leading brands such as Risk and WatersTechnology. The goal of Chartis Research is to support enterprises as they drive business performance through improved risk management, corporate governance and compliance, and to help clients make informed technology and business decisions by providing in-depth analysis and actionable advice on virtually all aspects of risk technology.

 

RiskTech Quadrant®, RiskTech100® and FinTech QuadrantTM are registered trademarks of Infopro Digital Services Limited (http://www.chartis-research.com).

 

About NICE Actimize

NICE Actimize is the largest and broadest provider of financial crime, risk and compliance solutions for regional and global financial institutions, as well as government regulators. Consistently ranked as number one in the space, NICE Actimize experts apply innovative technology to protect institutions and safeguard consumers and investors assets by identifying financial crime, preventing fraud and providing regulatory compliance. The company provides real-time, cross-channel fraud prevention, anti-money laundering detection, and trading surveillance solutions that address such concerns as payment fraud, cybercrime, sanctions monitoring, market abuse, customer due diligence and insider trading. Find us at www.niceactimize.com, @NICE_Actimize or Nasdaq: NICE.

 

About NICE

With NICE (Nasdaq: NICE), it’s never been easier for organizations of all sizes around the globe to create extraordinary customer experiences while meeting key business metrics. Featuring the world’s #1 cloud native customer experience platform, CXone, NICE is a worldwide leader in AI-powered contact center software. Over 25,000 organizations in more than 150 countries, including over 85 of the Fortune 100 companies, partner with NICE to transform – and elevate – every customer interaction. www.nice.com.

Trademark Note: NICE and the NICE logo are trademarks or registered trademarks of NICE Ltd. All other marks are trademarks of their respective owners. For a full list of NICE’s marks, please see: www.nice.com/nice-trademarks.

 

Forward-looking statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, including the statements by Mr. Costigan, are based on the current beliefs, expectations and assumptions of the management of NICE Ltd. (the “Company”). In some cases, such forward-looking statements can be identified by terms such as “believe,” “expect,” “seek,” “may,” “will,” “intend,” “should,” “project,” “anticipate,” “plan,” “estimate,” or similar words. Forward-looking statements are subject to a number of risks and uncertainties that could cause the actual results or performance of the Company to differ materially from those described herein, including but not limited to the impact of changes in economic and business conditions, including as a result of the COVID-19 pandemic; competition; successful execution of the Company’s growth strategy; success and growth of the Company’s cloud Software-as-a-Service business; changes in technology and market requirements; decline in demand for the Company’s products; inability to timely develop and introduce new technologies, products and applications; difficulties or delays in absorbing and integrating acquired operations, products, technologies and personnel; loss of market share; an inability to maintain certain marketing and distribution arrangements; the Company’s dependency on third-party cloud computing platform providers, hosting facilities and service partners;, cyber security attacks or other security breaches against the Company; the effect of newly enacted or modified laws, regulation or standards on the Company and our products and various other factors and uncertainties discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”). For a more detailed description of the risk factors and uncertainties affecting the company, refer to the Company’s reports filed from time to time with the SEC, including the Company’s Annual Report on Form 20-F. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company undertakes no obligation to update or revise them, except as required by law.

Contacts

Corporate Media Contact:

Cindy Morgan-Olson, +1 646 408 5896, ET, media@nice.com

Investors:

Marty Cohen, +1 551 256 5354, ET, ir@nice.com
Omri Arens, +972 3 763 0127, CET, ir@nice.com

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German film industry anxiously awaits new director for Berlinale, as rumors swirl

The German film industry is eagerly awaiting the appointment of the Berlin Film Festival’s new director, expected to be announced Tuesday.

 

So, as the guessing game surrounding the choice shifts into high gear, one thing looks increasingly clear: The new head will face considerable financial and political challenges at the Berlinale.

 

Speculation in the local industry has been rife with likely candidates to succeed Carlo Chatrian and Mariëtte Rissenbeek, who have co-led the Berlinale as artistic and executive directors since 2020 and will step down after this year’s edition when their respective mandates end.

 

A number of potential contenders have now quashed those rumors, among them Matthijs Wouter Knol, CEO and director of the European Film Academy, who made it clear to Variety that he was not in the running and was very content in his current post; Kirsten Niehuus, head of funding org Medienboard Berlin-Brandenburg, who said she was not a candidate; and Unifrance chief Daniela Elstner, who denied the speculation as false.

 

Also seen as a possible pick was Munich Film Festival director Christoph Gröner, who likewise appears happy to remain where he is.

 

“We are of course flattered by this appraisal, but I am at the helm of the Munich Film Festival along with [artistic co-director] Julia Weigl,” Gröner told Variety. “In view of the recent developments at the Berlinale, with a reduction in sections for German programming, we define ourselves as No. 1 for German filmmaking — and therefore also want to increasingly appeal to the international industry in the middle of summer. We can only wish the Berlinale all the best.”

 

While a completely unexpected selection is certainly possible, other names regularly discussed by industry insiders include Christoph Terhechte, artistic director of the International Leipzig Festival for Documentary and Animated Film (who declined to comment on the rumors); Christian Jungen, artistic director of the Zurich Film Festival; Berlinale programmer Paz Lázaro; and Maria Köpf, who recently stepped down as co-managing director of the German Film Academy. The latter three could not be reached for comment.

 

The Berlinale has been talented at keeping cards close to its chest. Rissenbeek wasn’t actually a candidate when she was appointed to co-helm the festival. She had actually been tapped by the then culture commissioner to find candidates for the post and walked out with the job.

 

Claudia Roth, Germany’s federal government commissioner for culture and media, triggered a furious international backlash in September with her decision to forego the festival’s dual-leadership structure and instead return to a single director to manage both the artistic and administrative aspects of the event – a move that made it impossible for Chatrian to continue in his role after Rissenbeek decided to step down following the 2024 edition. More than 400 filmmakers and talents, among them Martin Scorsese, Paul Schrader, Béla Tarr, Olivier Assayas, Kirsten Stewart and Margarethe von Trotta, signed a letter condemning the culture commissioner for the move.

 

Roth then set up a six-member committee tasked with the responsibility of finding a sole director to succeed Chatrian and Rissenbeek that included Oscar-winning director Edward Berger “(All Quiet on the Western Front);” producer Roman Paul “(Paradise Now);” Anne Leppin, the German Film Academy’s now sole managing director; actress and producer Sara Fazilat; State Secretary Florian Graf, head of the Berlin Senate Chancellery; and Roth herself.

 

Local observers also took Roth to task for not including people with more film festival expertise in her search committee.

 

Writing in Berlin daily Tagesspiegel, Andreas Busche expressed concern that there was “not a single person on the search committee” with a minimum of experience in international festival operations or at least curatorial expertise.

 

The Frankfurter Allgemeine Zeitung’s Andreas Kilb likewise addressed the difficulties of finding an ideal new director: “Those multi-talents who combine aesthetic flair with an instinct for film politics, stage presence with skill in dealing with sponsors and who also have a sense of finance are as rare as winning the lottery.”

 

Whoever takes the reins, the new leadership will have to deal with a precarious financial situation that could be exacerbated by the government’s current budget crisis. A ruling by Germany’s constitutional court last month blocked Chancellor Olaf Scholz’s government from tapping €60 billion ($64.4 billion) in unused pandemic emergency funds for ambitious climate protection measures and other expenditures, blowing a major hole in the federal budget.

 

The festival already drastically reduced its lineup earlier this year due to rising costs. Its budget last year amounted to some €32.3 million — that included €12.9 million in institutional funding from the federal government, which is expected to reduce that figure to €10.7 million next year. As a result, the state of Berlin has agreed to increase its contribution to the Berlinale from €20,000 to €2 million a year, local newspaper BZ reported. Financing for the Berlinale has been traditionally split three ways between federal funds, ticket sales and sponsorship, which has also reportedly seen significant cuts.

 

Media watchers like Busche have warned against growing political encroachment over the festival resulting from its funding needs following comments made by Christian Goiny, a representative of Berlin’s conservative CDU ruling party, who said increased financial support should be “accompanied conceptually and in terms of content.”

 

While the Berlinale has long been seen as a very political festival, there is concern that its artistic integrity could be further compromised if government overseers push for only the right kind of politics and further constrain the new director.

 

Pointing to Roth’s statement earlier this year that the Berlinale needed a good structure in order to “live up to its claim of being the largest public festival and a political film festival,” Busche stressed that the latter could “not be achieved by decree” but rather by its programming.

 

 

 

— Variety

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Mono Next in Thailand inks deal with Studio Genie of Korea: ATF

Thailand’s broadcast and streaming group Mono Next and Korea’s Studio Genie have struck a deal to collaborate on content creation and distribution.

 

Production of a Thai remake of a Korean series is on the cards, but has not been finalized. The memorandum was announced on stage at the Asia Television Forum in Singapore on Wednesday, with streaming unit Mono Streaming signing on behalf of the Thai group.

 

The on-stage announcement said that a Korean-to-Thai production is a likely product of the deal, but Mono subsequently told Variety that the show has not been identified and that plans are at an early stage.

 

Mono Next includes: free-TV channel Mono 29: Monomax ,an SVOD video streaming platform; and a partnership with 3BB, a Thai broadband provider.

 

In partnership with 3BB, a leading IPTV player, Mono Streaming Company Limited expands across IPTV, free-to-air, and cable channels, emphasizing dedication to diverse content accessibility.

 

“The collaboration between Mono Streaming and KT Studio Genie holds immense potential for creating groundbreaking content that transcends borders,” said Patompong Sirachairat, CEO at Mono Next. “We look forward to exploring new horizons in the entertainment industry together.”

 

“This memorandum of understanding signifies the beginning of a promising partnership between KT Studio Genie and Mono Streaming,” said Kim, Chul Yeon, at KT Studio Genie.

 

Studio Genie is part of the KT Group, formerly known as Korea Telecom, and is an assembly of KT’s media and content businesses. These include StoryWiz (planning, producing and distributing content including webtoons and web novels); Milly’s library (an online reading platform); and music streamer Genie Music. Some 18 months ago, CJ ENM announced that it was buying a stake in the business.

 

 

— Variety

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D&R Greenway’s Johnson Education Center in Princeton announces Holiday Open House and Art Sale for Saturday

The public is invited to a Holiday Open House and Art Sale on Saturday, Dec. 9 from 1 p.m.  to 4 p.m. at D&R Greenway Land Trust’s Johnson Education Center at One Preservation Place, Princeton.

 

Internationally acclaimed MUTTS cartoons by Patrick McDonnell, watercolors by James Fiorentino, botanical florals by artist Liz Cutler, and landscape quilts by Deb Brockway will be on display.

 

Art: Mutts comic panel referencing D&R Greenway preserved land

Sales benefit the land trust’s work to preserve and care for land, maintain public trails, grow food for the hungry, and inspire a conservation ethic.

 

The public is invited to enjoy cider, hot chocolate and cookies at a Holiday Open House at D&R Greenway’s Johnson Education Center at One Preservation Place.  Admission is free.

Art: On the Edge – Polar Bear by James Fiorentino
Art: David and Goliath by Liz Cutler
Art: Nosing In by Deb Brockway

 

A new exhibit featuring four award-winning artists will be view and art sales will benefit the land trust’s work to preserve and care for land, maintain public trails, grow food for the hungry, and inspire a conservation ethic.

 

Internationally acclaimed cartoonist Patrick McDonnell will be on hand to sign his books as holiday gifts. Twenty-five of his MUTTS cartoon prints, featuring environmental and animal themes, signed and remarqued with original drawings, are available for holiday gift-giving.

 

These specially selected artworks illustrate McDonnell’s overriding message of compassion and kindness, much needed in today’s world. His comic strip, begun in 1994, is now in over 700 newspapers and 20 countries.  Patrick has collaborated with Jane Goodall, Eckhart Tolle, His Holiness the Dalai Lama, and most recently with Marvel on a Superheroes book.

 

The lobby of the Johnson Education Center greets visitors with a large painting of a tiger, perfectly suited for Princeton University alumni.

 

Artist James Fiorentino began painting as a child and had his art featured in the National Baseball Hall of Fame in Cooperstown, N.Y., when he was just 15 years of age. He has created a set of baseball cards, as well as portraits of world heroes and celebrities.

 

He is showing his wildlife art in the Marie L. Matthews Gallery at D&R Greenway, with an emphasis on conservation of species. He will be available to talk with visitors on Dec. 9 about his experiences banding birds, observing wildlife and meeting celebrities.

 

Quilter Deb Brockway is known to many locally as a trail builder. She has participated for over a decade in building trails on preserved lands. An accomplished quilter, she turned to landscape quilting to depict the beauty she found in nature. Quilts on display show a butterfly alighting on a flower, a hiker walking past spring ephemerals on a forest path, a kayak nosing into the water with wildlife, and a cardinal attempting to camouflage among the trees. Brockway’s quilted wall hangings are beautiful to view and perfect for wintertime gift giving.

 

Retired Princeton Day School teacher Liz Cutler, who led the school’s sustainability club to inspire students to observe and care for nature, is showing her botanical art in memory of her son, Isaac. Together, they walked Greenway Meadows park throughout his lifetime. Liz turned to the meditative art of collecting and pressing flowers into unique artistic expressions during his illness. She follows the Flower Pressers Ethos to ensure that anything she collects will do no harm to the species or environment. New artwork that has never been shown before fills a dark wood room in the renovated barn that is the Johnson Education Center, bringing color to the room and a feeling of being surrounded by a wildflower meadow.

 

Plein air paintings created by the Garden State Watercolor Society will be available for purchase through a silent auction. These paintings depict different scenes from Hillside Farm, an 800-acre property with expansive views of Hopewell Valley. Hillside Farm was home to the late philanthropist Betty Wold Johnson who cared deeply about the importance of preserving as much land as possible.  Her two sons, Robert Wood Johnson, former United States ambassador to the United Kingdom and owner of the New York Jets football team; and Christopher Wold Johnson, Jets co-owner and businessman, donated the property to D&R Greenway in honor of their mother.

 

Linda Mead, CEO of D&R Greenway, who gathered these artists for this unique show and gifting opportunity, invites the public to the open house on Dec. 9.

 

“When this art went up on our walls, we were all taken aback by its individual beauty and collective magnitude. Join us to meet the artists and enjoy conversation with friends while you shop and support our mission!”

 

Information is available at www.drgreenway.org or by calling D&R Greenway at 609-924-4646.

 

About D&R Greenway Land Trust:

D&R Greenway Land Trust is an accredited nonprofit that has reached a new milestone of over 22,000 acres of land preserved throughout central New Jersey since 1989. By protecting land in perpetuity and creating public trails, it gives everyone the opportunity to enjoy the great outdoors. The land trust’s preserved farms and community gardens provide local organic food for residents of the region—including those most in need. Through strategic land conservation and stewardship, D&R Greenway combats climate change, protects birds and wildlife, and ensures clean drinking water for future generations. D&R Greenway’s mission is centered on connecting land with people from all walks of life. www.drgreenway.org; info@drgreenway.org. Follow us on Facebook and Instagram.

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Second edition of Emerge development program gets Singapore, Taiwan backing

The Singapore Film Commission and the Taiwan Creative Content Agency (TAICCA) have agreed to back training and development program, Emerge, which supports writers, directors and producers to develop Chinese-language original films.

 

The announcement was unveiled on Friday within the context of the Asia Television Forum (ATF) in Singapore. Signatories included the executive chair of SFC, Justin Ang and chairperson of TAICCA, Homme Tsai.

 

The 12-week programme will combine hybrid and virtual sessions held in both Singapore and Taiwan from March to May 2024. In-person classes are scheduled to take place in Singapore in March, hybrid workshops and consultations online and in Taiwan, culminating in a final pitch day and award ceremony, planned at the Marche du Film Market in Cannes, May.

 

The session will include experienced global film producers, directors and executives including Ron Howard, Sukee Chew (“Sugar23”), Trey Callaway (“9-1-1 Lonestar”), Derek Tsang (“Better Days”) and Jojo Hui (“The Warlords”) as guest lecturers.

 

This is the second edition of Emerge, after a previous round backed by TAICCA, Ron Howard and Brian Grazer’s Imagine Entertainment and Cora Yim’s Sixty Percent Productions.

 

“With the increasing demand for Asian storytelling all over the world, this collaboration provides a truly international platform for Singapore filmmakers to take their skills to the next level,” said Ang.

 

“Leveraging the resources of Hollywood and leading multinational film and television companies in Asia, the collaboration seeks to craft content that resonates on a global scale,” said TAICCA chair Homme Tsai.

 

“We had a successful inaugural Emerge with TAICCA and Sixty Percent Productions, which allowed us to work with talented storytellers that yielded results,” said Imagine executive chairmen Grazer and Howard, in a joint statement.

 

“Emerge has been fruitful since its launch last September, with five Taiwanese TV projects incubated and a TV series [Chang Kaichih and Chen Fang Chi’s “Gunshot”] greenlit by Public Television Service in Taiwan for further development. We are delighted to extend our program to developing films with filmmakers from Singapore,” said Yim.

 

 

— Variety

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Scandal-hit Japanese talent agency Johnny and Associates renamed as Starto Entertainment

Johnny & Associates, the Japanese talent agency that has been embroiled in a huge sexual abuse scandal, is rebranding itself as Starto Entertainment.

 

The name is derived from the words ‘star’ and ‘to’ implying “to head toward the future,” the group said on Friday.

 

“It is an expression of our commitment to all our artists current and yet to come, with whom we inaugurate a new era in accordance with their individual talents and personal goals,” the group explained.

 

Johnny & Associates was for many years the most powerful talent shop in Japan, creating idol groups such as Snow Man, and leveraging its male performers into film and TV roles.

 

It was brought low by a scandal relating to its founder Johnny Kitagawa who abused young male performers over a period of decades before his death in 2019. While this seems to have been known, but widely ignored by many in the industry, the scale of depravity and cover-up blew up earlier this year following a BBC documentary.

 

Two subsequent third-party investigations revealed details. And Johnny’s current management was forced to admit the events were factual. It also said that it would set up a compensation fund and investigate claims.

 

Corporate partners and sponsors, however, fled from the scandal. Some ended their use of Johnny’s talent in commercials. Others, such as state broadcaster NHK, chose not to book Johnny’s talent on its shows.

 

With a new name, Johnny’s appears to be trying again to put recent events behind it and to be looking forward again.

 

“Starto is, without any doubt, an entertainment team that represents the pride of Japan. Be it song, dance, or stagecraft, the first-class contents and national treasures of Japan have left an indelible mark around the world and mandate continued effort to meet the appropriately high expectations of their passionate fans,” it said.

 

Additionally, it set out three addition undertakings: greater digitization, including the establishment of a proprietary music streaming platform; increased global openness and overseas outreach; and “metaverse market entry”: extending artists’ talents with state-of-the-art technology.

 

“We will fervently apply ourselves toward a just, upright, bright, and international future for a new entertainment landscape,” it added.

 

 

— Variety

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Non-GMO now considered higher priority for tea consumers than Fair Trade by industry professionals

Firsd Tea’s new report suggests industry experts view Non-GMO certification as more important to consumers than Fair Trade.

 

“Importantly, Organic certification is still the predominant priority standard for consumers in the eyes of industry professionals.”

— Jason Walker, Marketing Director, Firsd Tea

SECAUCUS, N.J. — According to a new report from Firsd Tea, the largest importer of Chinese tea in the U.S., most professionals in tea and related industries say Non-GMO certification is now more important than Fair Trade for their consumers—a trend change from last year’s findings.

 

Specifically, most respondents in 2023 viewed Non-GMO certification (81%) as the second-most important standard and Fair Trade (68%) as the third-most important standard to consumers—a reversal from 2022’s survey findings.

 

“Though it’s unsurprising that Non-GMO certification has grown in perceived importance for consumers with our survey-takers, it was interesting to see it leap past Fair Trade certification this year,” Firsd Tea marketing director, Jason Walker, explains. He adds, “Importantly, Organic certification is still the predominant priority standard for consumers in the eyes of industry professionals.”

 

Along with revealing the Non-GMO certification’s increasing importance, the study also found:

  • Most survey-takers remain worried about the effects of climate change on their business operations (80% in 2022 vs. 75% in 2023).

 

  • Tea is still considered the most sensitive industry to the effects of climate change by most professionals in tea and related industries (93% in 2022 vs. 95% in 2023).

 

  • Most respondents in tea and related industries still agree Organic Certification is the most important standard to consumers (84% in 2022 vs. 88% in 2023).

 

  • Compared with Firsd Tea’s 2022 study, Vietnam (+37%), Kenya (+33%), China (+26%), and Sri Lanka (+26%) saw outstanding perceived sustainability improvements in 2023.

 

  • Most respondents in tea and related industries report improved outlooks on progress made in sustainability from 10 years ago, the current state of sustainability in tea, and the trajectory for the next 10 years.

 

“We look forward to this critical study providing important information to stakeholders across tea and related industries, hopefully helping their decision-making and giving them a more accurate pulse on their industry peers,” explains Firsd Tea executive director, Shengyuan Chen.

 

Firsd Tea Sustainability Perspectives 2023 is the second annual survey that continues a first-of-its-kind global 2022 study to gauge opinions of tea sustainability among associated experts.

 

“In this post-pandemic era, consumers remain focused on healthy lifestyles and recognize the importance of protecting the environment. The significance of organic certification with growing numbers of tea consumers echoes the mindset of many coffee consumers as well, specifically, that organic certification hits two touch points: it is good for the body and it is good for the planet,” says Vanessa L. Facenda, editor, Tea & Coffee Trade Journal.

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Kirby McInerney LLP announces the filing of a securities class action on behalf of Outlook Therapeutics, Inc. (OTLK) investors

NEW YORK — (BUSINESS WIRE) — $OTLK #classactionlawsuit — The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities during the period from Dec. 29, 2022 through Aug. 29, 2023, inclusive (the “Class Period”). Investors have until Jan. 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

 

Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. The Company’s lead product candidate is ONS-5010, an ophthalmic formulation of the antibody bevacizumab for the treatment of wet age-related macular degeneration (“wet AMD”) and other retina diseases.

 

In August 2021, Outlook announced the topline readout of data from its pivotal Phase 3 NORSE TWO trial of ONS-5010 for the treatment of wet AMD. According to the Company, this data, among other things, “demonstrated clinically relevant and highly statistically significant results” that supported the submission of a biologics license application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for ONS-5010 for the treatment of wet AMD, which the Company planned to submit to the FDA in the first quarter of 2022. In March 2022, Outlook announced that it had submitted the ONS-5010 BLA to the FDA.

 

In May 2022, the Company voluntarily withdrew the ONS-5010 BLA to provide additional information requested by the FDA. Following receipt of further correspondence from the FDA, the Company purportedly confirmed the additional information necessary to re-submit the BLA for ONS-5010 and resubmitted the BLA in August 2022.

 

On August 30, 2023, Outlook announced that the FDA had issued a complete response letter to the ONS-5010 BLA. The Company advised that the FDA could not approve the BLA during this review cycle due to several issues. On this news, the price of Outlook shares declined by $1.141 per share, or approximately 80.92%, from $1.41 per share to close at $0.269 on August 30, 2023.

 

The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) there was a lack of substantial evidence supporting ONS-5010 as a treatment for wet AMD; (ii) Outlook and/or its manufacturing partner had deficient chemistry manufacturing and controls and other manufacturing issues for ONS-5010, which remained unresolved at the time the ONS-5010 BLA was re-submitted to the FDA; (iii) as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form; and (iv) accordingly, ONS-5010’s regulatory and commercial prospects were overstated.

 

If you purchased or otherwise acquired Outlook securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.

 

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: https://www.kmllp.com.

 

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

Contacts

Kirby McInerney LLP

Thomas W. Elrod, Esq.

212-699-1180

https://www.kmllp.com
investigations@kmllp.com

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Nicolas Cage talks: ‘Superman’ that flopped, top five screenplays, filming the ‘most humiliating sex scene in the history of cinema’

From internet memes to a slew of movies, this is the Age of Cage, but Nicolas Cage himself revealed that as he approaches his 60th birthday he is taking stock.

 

He told a sold-out audience at the Red Sea Film Festival that he was winding down his film career after 45 years and over 100 films: “I want to do television; maybe Broadway.”

 

His decision – inspired in part by his son showing him “Breaking Bad” — won’t be final, as he has several film projects in the pipeline, including “Sympathy for the Devil,” co-starring festival jury member Joel Kinnaman and a sequel to 2005’s “Lord of War” — “My character’s son grows up and becomes a rival. It’s very Arthurian,” he said.

 

The Academy Award winning actor hyped by the “good energy” in the room talked through the four decades of his career and every film mentioned was greeted by whoops and applause from an enthusiastic to the point of deafening audience. Cage explained his name change – “Filmmakers don’t want the name Coppola above the title of their movies” – and shared many stories that spanned his entire career, at one point simply responding to whatever film the audience cried out. “Face/Off” was mentioned: “That one might be a masterpiece,” he said. “Ghost Rider” – “It’s like Disney made a film about Faust; like a tattoo which came to life.” Cage spotted a fan holding up a poster for the film and called her to the stage to show the audience, revealing he often goes on eBay to buy memorabilia from his own films as well as comic books of which he’s an avid collector.

 

Had acting not turned out, his Plan B had been to become a fisherman in Alaska, and so couldn’t help but talk about some of the films which got away. He was in play for the George Clooney role in “A Perfect Storm.” The film which he most regrets losing and which got the biggest cheer of the night was “Superman,” with Cage as the Man of Steel and Tim Burton directing: “The studio wanted Renny Harlin and were frightened it would cost too much money so they shut it down.”

 

While making “City of Angels” his decision to not blink as the angel was in preparation, he said, for playing the otherworldliness of Kal-El (aka Clark Kent) in the planned “Superman,” which would have immediately followed it. Cage also noted that he’d approached David Bowie to write a theme song for “Superman.”

 

The “Wild at Heart” star also paid respect to those who helped him in his career such as “Valley Girl” director Martha Coolidge who picked his headshot out of a pile; his uncle Francis Ford Coppola “was like a dad to me,” and co-stars such as Sean Connery. “He wanted to play golf and I wanted to go fishing and so we ended up talking about movies.” Cage’s clear intellectual philosophy when it comes to screen acting was clear. “Independent dramatic cinema is my well,” he said. And throughout the talk he characterized himself as a student always trying to push himself into zones of discomfort. He listed his top five screenplays as “Raising Arizona,” “Vampire’s Kiss,” “Leaving Las Vegas,” “Adaptation” and “Dream Scenario.” Two of his favorite films are “Pig” and “Dream Scenario.”

 

Securing an Oscar for “Leaving Las Vegas” was like getting tenure, Cage said. “My uncle sent a telegram that read ‘Congratulations Nicky, from Francis Cage.’” Having achieved critical recognition, Cage embarked on an unexpected stint as an action hero in films such as “The Rock” and “Con Air.” More recently he discovered that he had become a meme, googling his own name to find a series of videos entitled “Nicolas Cage loses his shit.” The shock left him “confused, frustrated and a little stimulated.” His new film “Dream Scenario,” about a man who finds that he is appearing in everyone’s dreams, is directly related to Cage’s own changing relationship to fame: “I suffered from the memeification and my character suffers from the dreamification.” It also features what he describes as “the most humiliating love scene in the history of cinema.”

 

Now Cage has taken to picking his projects more “severely and stringently” and is acutely aware of the passage of time. “I have a 15-month-old daughter waiting for me at home.” Asked if he shows his children his films, he laughs “absolutely not. We watch the cartoon ‘Invincible.’ It’s wild.”

 

 

 

— Variety