Accessibility StatementSkip Navigation NORTH CHICAGO, Ill., Sept. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the start of construction of its new active pharmaceutical ingredient (API) manufacturing plant in North Chicago, Illinois. This is a significant milestone in AbbVie's ongoing efforts to expand its U.S. manufacturing network, capabilities and capacity. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+Newsrooms &Influencers 9k+Digital MediaOutlets Continue Reading AbbVie ...

Industry Perspective - Biopharmaceutical innovation is considered a global public good [1] - The biopharmaceutical industry faces both high risk and high costs in innovation [1] Policy & Regulation - Reforms to European drug pricing are advocated [1]

Company Overview - Fortress Biotech, Inc. is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings, and dividend and royalty income [2] - The company has eight marketed prescription pharmaceutical products and multiple programs in development across various therapeutic areas including oncology, dermatology, and rare diseases [2] - Fortress leverages its significant biopharmaceutical industry expertise and network to expand and advance its portfolio of product opportunities [2] Partnerships and Collaborations - Fortress has established partnerships with leading academic research institutions and biopharmaceutical companies, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children's Hospital, Columbia University, Dana Farber Cancer Center, and Sentynl Therapeutics [2] Upcoming Events - Lindsay A. Rosenwald, M.D., Chairman, President, and CEO of Fortress, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference, with the presentation available for on-demand viewing starting September 5, 2025 [1] - The company will also participate in virtual one-on-one meetings during the conference from September 8-11, 2025 [1]

AstraZeneca CEO Pascal Soriot on Tuesday reiterated the pharmaceutical firm's commitment to the U.S. market amid reports that he is considering shifting its listing stateside. Soriot said the U.K.-listed company had many reasons to be in the U.S., adding that it was "rapidly transferring manufacturing" across the Atlantic so it could serve all U.S. patient needs domestically. "We are a global company but we are certainly, very much, present and rooted in the U.S.," Soriot said, noting that it plans to soon ...

Core Points - Hoth Therapeutics, Inc. has regained full compliance with Nasdaq's minimum bid price requirement, closing at or above $1.00 for 10 consecutive trading sessions from June 4 to June 17, 2025 [1][2] - The CEO of Hoth Therapeutics, Robb Knie, stated that regaining compliance is a significant milestone that reflects growing market confidence in the company's strategy and pipeline [3] - The company is strategically focused on delivering key milestones across multiple therapeutic areas, including inflammatory diseases, oncology, and rare diseases [3] Company Overview - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing innovative therapies for patients with unmet medical needs, targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions [4]

Core Viewpoint - Idorsia Ltd announces the appointment of Dr. Srishti Gupta as the new CEO effective July 1, 2025, succeeding André C. Muller, who will transition to an advisory role to ensure a smooth leadership change [1][3][4]. Group 1: Leadership Transition - Dr. Srishti Gupta has been a board member since 2021 and is well-positioned to lead the company due to her deep understanding of Idorsia's operations and product portfolio [1][2]. - André C. Muller, the current CEO, will retire and take on an advisory role, having successfully led the company through financial restructuring and the commercial ramp-up of QUVIVIQ in the EUCAN region [3][4]. - The leadership transition aims to maintain stability and continuity as the company focuses on advancing its product portfolio and achieving profitability by the end of 2027 [4][5]. Group 2: Dr. Srishti Gupta's Background - Dr. Gupta has over 20 years of experience in global health and biopharmaceutical innovation, with a strong background in strategy and healthcare systems [2][8]. - She previously spent 18 years at McKinsey & Company, where she held senior leadership roles in the pharmaceutical and global health practices [2][9]. - Dr. Gupta holds an MD from Harvard Medical School and multiple degrees from Harvard University and the University of Cambridge, showcasing her strong academic credentials [8][9]. Group 3: Company Outlook - The company is optimistic about the commercial success of QUVIVIQ, which is gaining traction in Europe, and is reactivating collaboration discussions for TRYVIO [5][12]. - Dr. Gupta emphasizes the need for balancing ambition with financial discipline, indicating a focus on smart investments in promising assets [5][6]. - Idorsia aims to evolve into a leading biopharmaceutical company, committed to discovering and commercializing transformative medicines [11][12].

Core Insights - Ocular Therapeutix has successfully completed enrollment for the SOL-R trial, the largest retinal TKI trial to date, with a target randomization of at least 555 subjects [1][2][6] - The SOL-1 trial, which is complementary to SOL-R, completed randomization in December 2024 and is on track for top-line readout in Q1 2026 [1][2] - Both trials are designed to support a New Drug Application (NDA) submission for AXPAXLI in wet age-related macular degeneration (wet AMD) [1][3][4] Company Overview - Ocular Therapeutix is a fully-integrated biopharmaceutical company focused on redefining the retina experience [14] - AXPAXLI, the investigational product candidate, is a bioresorbable intravitreal hydrogel incorporating axitinib, aimed at treating wet AMD and other retinal diseases [5][14] - The company is leveraging its proprietary ELUTYX technology in both AXPAXLI and its commercial product DEXTENZA [15] Clinical Trials - The SOL-R trial is a Phase 3 registrational study evaluating the safety and efficacy of AXPAXLI, involving approximately 100 sites across the U.S., Argentina, India, and Australia [6][8] - The primary endpoint of SOL-R is to demonstrate non-inferiority in mean change in best corrected visual acuity (BCVA) compared to aflibercept at Week 56, with a non-inferiority margin of -4.5 letters [8][11] - The SOL-1 trial aims to evaluate the proportion of subjects maintaining visual acuity at Week 36, with a focus on durability up to Week 52 [11][9] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.7 million in the U.S. [12][13] - Current treatments face challenges such as the need for frequent injections and high patient discontinuation rates, highlighting the need for more durable therapies [13] - AXPAXLI has the potential to significantly reduce treatment burden and improve long-term vision outcomes for patients with wet AMD [3][4]

Core Insights - Avadel Pharmaceuticals has appointed Susan Rodriguez as Chief Operating Officer to lead the company's commercial strategy and operations, particularly in relation to the launch of LUMRYZ [1][2][17] - Rodriguez brings over 30 years of experience in the life sciences industry, having held leadership roles in various biopharmaceutical companies, which positions her well to support Avadel's growth and market expansion [2][17] Company Developments - LUMRYZ, an extended-release sodium oxybate medication, was approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy [3][5][17] - The FDA also approved LUMRYZ for pediatric patients aged 7 years and older on October 16, 2024, further expanding its market potential [3][5] Clinical and Regulatory Highlights - The approval of LUMRYZ was supported by the REST-ON™ Phase 3 trial, which demonstrated significant improvements in excessive daytime sleepiness, overall patient functioning, and cataplexy attacks compared to placebo [4][5] - LUMRYZ has been granted 7 years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, providing a once-nightly dosing regimen that enhances patient care [5][6] Market Position and Strategy - The company aims to scale operations to meet increasing patient demand for LUMRYZ, particularly in the narcolepsy community, and is exploring potential label expansion to include idiopathic hypersomnia [2][17] - Rodriguez's expertise in launching innovative therapies in rare diseases is expected to be instrumental in accelerating the growth of LUMRYZ and maximizing its market impact [2][17]

Core Insights - Nxera Pharma has made significant progress since its transformation from Sosei Heptares, aiming to lead biopharmaceutical innovation in Japan and globally [2][3] - The company anticipates 2025 to be a pivotal year with key data readouts from multiple clinical trials and new studies commencing [3] Operational Highlights - Neurocrine initiated a Phase 3 program for NBI-1117568 targeting schizophrenia, supported by positive Phase 2 data [5] - Nxera assigned rights for cenerimod to Viatris, receiving an upfront payment of US$10 million, with additional milestone and royalty potential [6] - An agreement was signed with Holling Bio-Pharma for the commercialization of daridorexant in Taiwan, with a potential launch in 2026 [6] - Clinical development plans for partnered muscarinic agonists include multiple Phase 2 and Phase 3 studies scheduled for 2025 [6] Financial Highlights - Revenue for Q1 2025 totaled JPY 6,644 million (US$43.5 million), an increase of JPY 2,033 million (US$12.5 million) year-over-year, primarily due to the launch of QUVIVIQ® and an R&D milestone event [11] - R&D expenses rose to JPY 3,808 million (US$25.0 million), reflecting increased investment and the impact of a weaker Yen [11] - Operating loss improved to JPY 2,193 million (US$14.4 million) from JPY 3,076 million (US$20.7 million) in the prior year [11] - Net loss decreased to JPY 760 million (US$5.0 million) from JPY 3,281 million (US$22.1 million) in the previous year [11] - Cash and cash equivalents as of 31 March 2025 were JPY 34,465 million (US$230.0 million), an increase of JPY 2,197 million (US$24.3 million) since the beginning of the year [11] Corporate Developments - New appointments to the Board of Directors include Ms. Naoko Shimura and Ms. Nicola Rabson as External Directors [6] - Mr. Kiyoshi Kaneko was appointed Chief Commercial Officer, and Ms. Mariko Nakafuji was promoted to Chief Legal Officer [11] Pipeline and Strategy - Nxera is advancing over 30 active programs from discovery to late clinical stages, focusing on neurology, metabolic diseases, and immunology [10][12] - The company aims to address major unmet needs in rapidly growing medical areas, leveraging its NxWave™ discovery platform [10][12]

Core Insights - Innovent achieved historic milestones in 2024, with Non-IFRS net profit of RMB 331.6 million and Non-IFRS EBITDA of RMB 411.6 million, marking the first positive results in these metrics [5] - Total revenue reached RMB 9,421.9 million, a year-over-year growth of 51.8%, with product sales revenue growing by 43.6% to RMB 8,227.9 million [5] - The company aims for RMB 20 billion in product revenue by 2027 and plans to advance five pipeline assets to global MRCT Phase 3 by 2030 [2][9] Financial Performance - Non-IFRS profit and EBITDA turned positive for the first time, indicating improved financial health [5] - Gross profit margin increased to 84.9%, up by 2.1 percentage points year-over-year [5] - Selling, General and Administrative (S,G&A) expenses ratio decreased to 50.9%, down by 7.1 percentage points year-over-year [5] Product Development and Pipeline - Innovent expanded its product portfolio to 15 approved products and plans six new product launches in 2025 [5][9] - Key pipeline assets include Dovbleron®, Limertinib, and Jaypirca®, targeting oncology and chronic diseases [5] - The company is advancing multiple next-generation programs in oncology and autoimmune diseases, with promising Phase 1 results reported [9] Strategic Goals and Partnerships - Innovent is focused on becoming a premier global biopharmaceutical company, emphasizing sustainable growth and innovation [2][9] - The company has established partnerships with over 30 global healthcare companies, enhancing its research and development capabilities [10] - Innovent's commitment to ESG practices is reflected in its 'AAA' rating in MSCI ESG rankings and various community support initiatives [9][10]