Biopharmaceutical Giant Amgen to Settle FTC and State Challenges to its Horizon Therapeutics Acquisition

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The Federal Trade Commission reached a proposed consent order with Amgen Inc. to address the potential competitive harm that would result from Amgen’s $27.8 billion acquisition of Horizon Therapeutics plc. As part of a nationwide settlement of their challenge to the acquisition, the FTC and attorneys general from six states – California, Illinois, Minnesota, New York, Washington, and Wisconsin – also will dismiss the related federal court preliminary injunction action.

“Consolidation in the pharmaceutical industry has given companies the power and incentive to engage in exclusionary rebating practices, which can lead to sky-rocketing prices on essential medications,” said Henry Liu, Director of the FTC’s Bureau of Competition. “Today’s proposed resolution sends a clear signal that the FTC and its state partners will scrutinize pharmaceutical mergers that enable such practices, and defend patients and competition in this vital marketplace.”

Under the proposed order, Amgen is prohibited from bundling an Amgen product with either Tepezza or Krystexxa, Horizon’s medications used to treat thyroid eye disease (TED) and chronic refractory gout (CRG), respectively. In addition, Amgen may not condition any product rebate or contract terms related to an Amgen product on the sale or positioning either one of these drugs. Amgen also is barred from using any product rebate or contract term to exclude or disadvantage any product that would compete with Tepezza or Krystexxa.

The proposed consent order resolves FTC and state charges that Amgen’s acquisition of Horizon is anticompetitive, as the deal would enable Amgen to leverage its large portfolio of blockbuster drugs to pressure insurance companies and pharmacy benefit managers into favoring Horizon’s two monopoly products – Tepezza and Krystexxa – or disadvantaging rivals to Tepezza or Krystexxa.

The proposed order also will prohibit Amgen from entering into any agreement or understanding to acquire any products or interest in any business engaged in the manufacturing or sale of any products, biosimilars, or therapeutic equivalents that treat either TED or CRG, unless it receives prior approval from the Commission.

Additionally, Amgen must seek FTC approval if it seeks to acquire any pre-commercial products that have completed FDA clinical trials to treat either thyroid eye disease or chronic refractory gout. Under the terms of the consent order, Amgen is required seek FTC such prior approval through 2032 and notify the states if it is seeking Commission approval.

All other requirements in the consent order will be effective for 15 years after it is finalized, including a requirement that Amgen submit annual compliance reports to the FTC and states. A monitor will be appointed to oversee Amgen’s compliance, and the monitor’s reports will likewise be submitted to the Commission and to the states.

The FTC’s proposed consent order, among other conditions, also requires that Amgen:

  • Submit to the monitor all contracts with payers related to the formulary coverage, placement, or positioning of Krystexxa or Tepezza in the United States within 30 days of entering into such contract.
  • Notify the monitor if either Krystexxa or Tepezza meets all three of the following conditions: 1) Krystexxa or Tepezza has been approved by the FDA for patient self-administration; 2) the self-administered version of Krystexxa or Tepezza is available on the market; and 3) the self-administered version of Krystexxa or Tepezza is otherwise eligible to be covered as a pharmacy benefit product.
  • Require, annually, that all Amgen employees with direct involvement in contracting or negotiations with payers related to the purchase, coverage, placement, or positioning of Krystexxa or Tepezza in the United States to review the consent order acknowledge in writing (including by email) that they understand and are complying with the obligations of the order.

In May 2023, the FTC filed a complaint in the U.S. District Court for the Northern District of Illinois to block the proposed transaction. In addition to alleging that the transaction would give Amgen the ability and incentive to foreclose rivals to Tepezza and Krystexxa, the complaint stated that the deal also would entrench Tepezza’s and Krystexxa’s monopoly positions in the TED and CRG markets, respectively, by substituting Amgen, with its broad and powerful portfolio of blockbuster drugs, for Horizon with its smaller portfolio, thus raising entry barriers and dissuading smaller firms from competing aggressively. This was the FTC’s first litigated challenge to a pharmaceutical merger in more than a decade.

Further details about the proposed order can be found in the analysis to aid public comment.

The Commission vote to accept the proposed consent order for public comment was 3-0, with Chair Lina M. Khan issuing a separate statement, in which she was joined by Commissioner Rebecca Kelly Slaughter and Commissioner Alvaro Bedoya.

The FTC will publish the consent agreement package in the Federal Register shortly. Instructions for filing comments appear in the published notice. Comments must be received 30 days after publication in the Federal Register. Once processed, comments will be posted on Regulations.gov.

NOTE: When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions.

Official news published at https://www.ftc.gov/news-events/news/press-releases/2023/09/biopharmaceutical-giant-amgen-settle-ftc-state-challenges-its-horizon-therapeutics-acquisition

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Hanna Interpreting Services Awarded Comparably’s Best Company for Work-Life Balance

Hanna Interpreting Services, a premier language services provider, is proud to announce its recognition by Comparably as one of the best companies for work-life balance. This honor is a testament to the company’s unwavering commitment to employee well-being and its innovative approach to fostering a harmonious work environment.

Comparably’s accolade assesses factors such as employee satisfaction with work-life balance, average hours worked per day, lunch break lengths, and overall feelings of burnout. Hanna Interpreting Services' dedication to creating an environment that melds productivity with personal time has made it stand out in this evaluation.

A significant contributor to this balance is the company's hybrid working model, where employees merge the best of both worlds by working remotely for three weeks and in the office for one week every month. This flexibility allows team members to maintain their personal lives while still fostering in-person collaboration. Hanna also ranked among the top 35% of companies for diversity and in the top 40% for gender balance.

"It's a balance we've been striving to achieve, especially in these dynamic times," says President Tom Elias Hanna. "We understand the challenges presented by both remote work and the need to be in-office."

September is a monumental month for Hanna Interpreting Services. In addition to the Comparably award, the company celebrated its 13th anniversary on September 9, marking over a decade of industry leadership and commitment to bridging linguistic barriers. The month also saw the inauguration of a brand-new office space, showcasing the company’s dedication to growth and serving as a hub for innovation and team collaboration.

As Hanna Interpreting Services continues to evolve and set benchmarks in the industry, the core values remain consistent: a commitment to bridging language barriers, a dedication to employee well-being, and a vision to be the most trusted name in language services.

Founded in 2010 by mother and son duo Jennifer Hanna and Tom Elias Hanna in their garage, Hanna has grown to more than 70 employees, served 1.1 million clients to date in 250+ languages, and has sponsored countless outreach events to serve the local community.

For more information about Hanna Interpreting Services or to schedule an interview, please contact Sean Spicer, Revenue Operations Manager, at Sean.Spicer@HannaIS.com
 

Contact Information:
Sean Spicer
RevOps Manager
sean.spicer@hannais.com
(619) 963-2331


Original Source: Hanna Interpreting Services Awarded Comparably's Best Company for Work-Life Balance

With Nearly 2,000 Athletes, the 2023 JCC Maccabi Games & Access, North America’s Largest Jewish Teen Sports and Community Building Event, Leaves a Lasting...

With Nearly 2,000 Athletes, the 2023 JCC Maccabi Games & Access, North America’s Largest Jewish Teen Sports and Community Building Event, Leaves a Lasting Impact
Boys 16U Soccer Finals

The Fort Lauderdale Maccabi Soccer team won their gold medal match against the Philadelphia team.

The 2023 JCC Maccabi Games® & Access, hosted by the David Posnack Jewish Community Center (DPJCC) in Fort Lauderdale, Florida, have concluded with resounding success and heartfelt gratitude to the community that made it all possible. This week-long celebration of sports, camaraderie, and inclusivity has left a lasting impact, thanks to the dedicated efforts of our generous supporters.

Close to 2,000 Jewish teen athletes aged 12-16, representing communities worldwide, gathered in Fort Lauderdale to experience the joy of sports and the power of inclusion. The Games, presented by the JCC Association of North America, offered an unforgettable Olympic-style experience filled with competitions, opening and closing ceremonies, community service, social and cultural events, and opportunities to create Jewish connections that will last a lifetime.

One of the highlights of this year's event was the introduction of JCC Maccabi Access, brought to you by UKG and presented by the Posnack Family Foundation. This program is designed to provide athletes aged 12-18 with intellectual and developmental disabilities an inclusive Maccabi experience. This three-day program, held in conjunction with the 2023 JCC Maccabi Games®, exemplified the event's commitment to inclusivity and diversity.

Scott Ehrlich, CEO of the David Posnack Jewish Community Center, reflected on the Games, stating, "We were overjoyed to welcome Jewish athletes from all corners of the world to Broward County for the 2023 JCC Maccabi® Games & Access. Our heartfelt appreciation goes to our JCC Maccabi Team led by our Co-Chairs, Lori and Mitch Green, Debby and Dennis Eisinger, Davia and Jim Mazur, and Missy and Dan Longman. Their unwavering commitment contributed significantly to establishing an atmosphere that nurtured camaraderie, inclusiveness, and the genuine essence of the Games."

The Games' success was significantly bolstered by the support of honorary co-chairs Scott Scherr, founder of Ultimate Software, and Scot Hunter, co-founder of Emerald Multi-Family Office. Their encouragement to business owners and the backing of corporate and community partners played a pivotal role in the event's success.

Supporting Corporate Sponsors:

  • Emerald Multi-Family Office
  • Southern Glazer's Wine & Spirits
  • Official Torch Sponsor: Duty-Free America
  • Kent Security
  • Official Beverage Sponsor: Coca-Cola 
  • The Meltzer Group
  • Official Transportation: Sponsor Comcast 
  • Official Media Partner: Clear Channel Outdoor 
  • Official Produce Sponsor: ProEx International
  • Official Pun, Pass, and Kick Sponsor: Miami Dolphins
  • Official Basketball Sponsor: Miami HEAT
  • Official Baseball Sponsor: Miami Marlins
  • Official Cleaning Company Sponsor: AK Building Services
  • Official Swimming Sponsor: Blavatnik Family Foundation 
  • Northland Investments
  • Official V-VIP Dinner Sponsor: Aroma Market & Catering
  • Custom Outfitters LLC
  • FP&L
  • Greenspoon Marder
  • Manne Foundation for Homeless Prevention
  • Official Mitzvah Sponsor: Children's Services Council of Broward County

The 2023 JCC Maccabi Games® & Access were not just about competition; they were also about giving back to the community. The JCC Cares Mitzvah Projects showcased the spirit of service, assembling over 1,000 Rosh Hashanah food baskets for Goodman JFS Seniors and Holocaust Survivors, donating over 2,500 pairs of new sneakers to students, in partnership with Children's Services Council of Broward County, and repurposing 340 medals for the "We Finish Together" organization, spreading kindness to ill children and adults in hospitals.

Among the highlights:

  • Approximately 10,000 spectators attended the Opening Ceremony at FLA Live Arena.
  • 1,620 visiting athletes.
  • 21 Access participants.
  • 375 Coaches & Chaperones.
  • 850 Community Volunteers.
  • 600 Host Families.
  • 215 Local Athletes & Access participants representing Team Fort Lauderdale.
  • 64 delegations, including international representation from Israel, Ukraine, Argentina, South Africa, Mexico, Canada, Great Britain, and 53 cities throughout the USA.
  • 100 Local businesses and individuals generously supporting.
  • 110,000 bottles of Dasani water, Powerade, and soda provided by Coca-Cola.
  • 47,000 pounds of ice used.
  • 20,000 meals served.
  • 300 athletes and coaches wrapped tefillin daily.

As the Games came to a close, the resounding message was one of unity, inclusivity, and the power of community. The 2023 JCC Maccabi Games® & Access will be remembered not only for the athletic achievements but also for the lasting friendships, cultural exchanges, and shared experiences that will continue to enrich the lives of all those who participated.

For more information about the 2023 JCC Maccabi Games® & Access and how you can support future events, please visit dpjcc.org.

Contact Information:
Rixys Alfonso
Corporate Sponsorship Consultant
rixys@causemomarketing.com
305-558-8877

Scott Ehrlich
Chief Executive Officer
sehrlich@dpjcc.org
954-434-0499, ext. 313
Related Images
Boys 16U Soccer Finals
Boys 16U Soccer Finals

The Fort Lauderdale Maccabi Soccer team won their gold medal match against the Philadelphia team.

Ukrainian team with Stanley
Ukrainian team with Stanley

The Ukranian team, sponsored by the David Posnack JCC, poses with Stanley C. Panther at opening ceremonies of the JCC Maccabi Games & Access.

JCC Access Games Athlete & Coaches
JCC Access Games Athlete & Coaches

Nico poses with his coaches during a skill competition at the Maccabi Access games.



Original Source: With Nearly 2,000 Athletes, the 2023 JCC Maccabi Games & Access, North America's Largest Jewish Teen Sports and Community Building Event, Leaves a Lasting Impact
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