Administrative Assistant

8/19/2026 - federal Court dismisses manufacturers' broader challenges to HRSA's STD entity certification process, leaving process intact. On August 14, 2026, the United States District Court for the District of Columbia issued a dispositive Memorandum Opinion ("Opinion") in the litigation brought by Amgen, Eli Lilly, Genentech, and UCB against HRSA. The litigation challenges HRSA's certification and recertification of entities that qualify for the 340B Program under Section 340B(a)(4)(K) of the Public Health Service Act ("Act") based on their receipt of sexually transmitted disease funding through a state or local government under Section 318 of the Act ("STD covered entities"). The Opinion avoided tackling the most impactful issues raised by the litigation, including whether: * STD covered entities qualifying for the 340B program solely based on receipt of in-kind funding are eligible; * STD covered entities may provide 340B drugs for conditions not directly related to the treatment of STDs; * STD covered entities must be primarily devoted to the treatment of STDs to qualify for the 340B program; and * HRSA's process for certifying and recertifying STD covered entities is unlawful. The Opinion solely invalided certain registrations tied to Sagebrush Health Services of its contracted partners on the basis that a "sub-sub-recipient" is ineligible to be registered by HRSA as an STD covered entity. The cases brought by the four drug manufacturers challenged HRSA's certifications and recertifications of STD covered entities: * that render services unrelated to the treatment of STDs; * that provide 340B drugs to patients for conditions not directly related to the treatment of STDs; * that receive their Section 318 funds from a subgrantee other than a unit of state or local government ("sub-sub grantees"); * that receive in-kind funding (rather than dollars) from a unit of state or local government; and * on the basis that HRSA failed to follow statutory requirements in the development of its STD entity certifications and recertifications. Community Care Resources of Florida ("CCRF"), a non-profit STD entity in Florida, intervened in support of HRSA as an intervenor-defendant in the litigation to represent the interests of STD entities in the case, and Powers represented CCRF. The manufacturers moved for summary judgment in their favor on each of its claims, and the government and CCRF cross-moved for summary judgment to dismiss each of the claims. CCRF did not defend the sub-sub grantee claim described above. Chief Judge James E. Boasberg issued the Opinion. The Opinion focused on the sub-sub grantee issue and declined to review the manufacturers' other theories regarding STD covered entity certifications and recertifications. Instead, the Court limited its analysis to the Sagebrush registrations identified in the manufacturers' complaints, concluding that invalidating those clinics' certifications provided the manufacturers with the appropriate relief and made it unnecessary to address their broader challenges to HRSA's certification process. The Opinion will largely be seen as a victory for HRSA and STD covered entities because of what it did not do. STD covered entities feared that the Court might interpret the 340B statute in such a way as to preclude eligibility for entities that solely receive "in-kind" funds from state or local governments, or that it might limit 340B drug utilization to drugs that specifically treat STDs (which also could have had significant impacts on Ryan White HIV/AIDS Clinics), or that it might limit eligibility to entities that primarily focus on the treatment of STDs. Perhaps most worrisome, the Court could have ruled that HRSA's entire STD covered entity certification and recertification process is invalid and declared all STD covered entity registrations void. All of those disruptive outcomes were avoided in the Opinion. As a result, the Opinion, unless appealed and set aside, will result in the decertification of the Sagebrush Health Services registrations at issue in the suit. HRSA would likely also decertify other sub-sub grantee STD covered entities. Therefore, Rwc-340b believe the suit will not impact any other STD covered entities. Finally, it is notable that the Court dismissed other manufacturer claims "without prejudice," which signals that manufacturers may bring similar claims against HRSA in the future. Powers will continue to monitor developments regarding this litigation. Please contact Powers' drug pricing team, or your lead Powers attorney, if you have any questions.

UCB, a global biopharmaceutical company, has been named a winner of the 2026 Metro Atlanta Top Workplaces Award by Axios. The recognition, based on confidential employee feedback, comes as UCB expands its Georgia presence through a $2 billion investment in a new biomanufacturing campus in Gwinnett County. The facility is expected to create more than 330 permanent, highly skilled jobs and generate an estimated $5 billion in economic impact. UCB has maintained its US headquarters in metro Atlanta for over 30 years and currently employs more than 400 people in Georgia. The award was given to fewer than 60 organisations with 159-499 employees across metro Atlanta, based on surveys administered by third-party firm Energage.

Axios names UCB a winner of the Metro Atlanta Top Workplaces 2026 award. Aug 16, 2026, 8:05 AM ET Recognition reflects employee feedback and comes as UCB expands its Georgia footprint through a $2 billion investment in a new biomanufacturing campus expected to create more than 330 jobs. ATLANTA, Aug. 16, 2026 /PRNewswire/ - UCB, a global biopharmaceutical company with its U.S. headquarters in metro Atlanta, has been named a winner of the 2026 Metro Atlanta Top Workplaces Award by Axios. As UCB expands its presence in Georgia, the Top Workplaces award reinforces the company's long-term investment in the state, its growing life sciences offering, and its overall culture that attracts, develops, and retains the talent needed to support innovation and a reliable medicine supply for U.S. patients. UCB has maintained its U.S. headquarters in metro Atlanta for more than 30 years and employs more than 400 people in Georgia. Earlier this year, UCB announced a $2 billion investment in a new biomanufacturing campus in Gwinnett County expected to create an additional 330+ permanent, highly-skilled jobs and generate an estimated $5 billion in economic impact. "This recognition is especially meaningful because it reflects the voices and experiences of our people," said Taco van Tiel, Head of UCB, U.S. "As UCB continues to invest in Georgia, including through our planned U.S. biologics manufacturing site, our ability to attract and support top talent will be central to delivering on our purpose for patients. We are proud to be part of the metro Atlanta community and to continue building a workplace where employees feel empowered to contribute, grow, and make an impact." EMPLOYEE FEEDBACK DRIVES TOP WORKPLACE RECOGNITION Awarded to fewer than 60 organizations with 159-499 employees across metro Atlanta, the recognition is based solely on employee feedback collected through a confidential third-party survey administered by Energage. UCB was previously a recipient of this award in 2021. "Creating an environment where talented people can do their best work is fundamental to our success at UCB. This recognition reflects the culture our employees have helped build, one rooted in collaboration, growth, and a shared commitment to improving the lives of people living with severe diseases," said Michele Ehler, Head of U.S. Talent, UCB, "We always strive to create a workplace where employees feel valued and empowered to make a difference, and we remain focused on investing in them as we grow and advance our mission in the years ahead." UCB remains focused on creating an environment where employees can thrive, develop their careers, and contribute to meaningful work. By continuing to invest in its people and culture, UCB is building the foundation needed to support future growth and deliver its commitment to patients. UCB'S GROWING PRESENCE IN GEORGIA Georgia plays a central role in UCB's long-term growth strategy in the United States. In addition to serving as the home of the company's U.S. headquarters, the state will become home to UCB's first U.S. biomanufacturing campus. FOR FURTHER INFORMATION: U.S. Communications Erica Puntel T 404.938.5359 email [email protected] About UCB in the U.S. UCB has maintained a significant U.S. presence for decades, including its U.S. headquarters and eight offices across six communities in California, Georgia, Massachusetts, North Carolina, Washington, and Washington, D.C. With nearly 2,000 U.S. employees focused on research, development, and commercial operations across the country, UCB is adding a U.S. biomanufacturing campus in Georgia, which will create 330+ new, highly skilled jobs. UCB has increased its U.S. workforce by more than 70% since 2017, with over 25% of U.S. employees dedicated to R&D. Over the last decade, UCB has made significant investments in U.S. companies through acquisitions and partnerships and has achieved 15 FDA approvals, advancing innovation, supporting high-quality jobs, and delivering meaningful progress for patients. About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9 000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). Forward looking statements This document contains forward-looking statements, including, without limitation, statements containing the words "potential", "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of UCB's information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in laws and/or rules pertaining to tax and duties or the administration of such laws and/or rules, and hiring, retention and compliance of employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. SOURCE UCB NOTE: This content is not written by or endorsed by "WOWK", its advertisers, or Nexstar Media Inc.