A compilation of recently released news briefs that pertain to the clinical trials industry.
Eli Lilly and Company is implementing new leadership and strategic direction in oncology R&D, combining the Lilly Research Laboratories (LRL) oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The new organization, named Loxo Oncology at Lilly, will be led jointly by Josh Bilenker, MD, Jacob Van Naarden, and Nisha Nanda, PhD, and will report into Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of LRL. David Hyman, MD, will join the leadership team as chief medical officer of the new organization, beginning in January. He currently serves as chief of the early drug development service at Memorial Sloan Kettering Cancer Center.
The new organization will be responsible for discovery research across therapeutic modalities, clinical development, and regulatory affairs for oncology. As new medicines approach U.S. regulatory approval, program responsibility will transition to Lilly’s Oncology Business Unit, led by Anne White.
Novartis AG and The Medicines Company have entered into a definitive agreement in which Novartis will acquire The Medicines Company for $85 per share in an all-cash transaction, implying a fully diluted equity value of $9.7 billion. The transaction was unanimously approved by the boards of both companies and completion is expected in the first quarter of 2020.
Based in Parsippany, NJ, The Medicines Company focuses on treatments for cardiovascular disease, specifically halting the progression of atherosclerosis and the cardiovascular risk created by high levels of LDL-C, or bad cholesterol.
UsAgainstAlzheimer’s has created a new online biomarkers repository to track research into Alzheimer’s disease biomarkers and diagnostics. Many potential biomarkers are being studied for use in a number of contexts, such as patient stratification, target engagement, as surrogate endpoints, and for use in clinical practice as diagnostic tools for early detection and diagnosis of disease.
Alkermes plc will acquire Rodin Therapeutics, Inc., a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics for synaptopathies. This transaction builds on Alkermes’ experience in CNS diseases and expands Alkermes’ CNS development efforts into a wide range of neurodegenerative disorders.
Vertex Pharmaceuticals and Molecular Templates, Inc. have entered into a strategic research collaboration to discover and develop novel targeted conditioning regimens that may enhance the hematopoietic stem cell transplant process, including transplants conducted as part of treatment with ex vivo CRISPR/Cas9 gene editing therapies.
PPD, Inc. has expanded its early development research services, broadening the CRO’s capabilities to provide increased access to patients and special populations at PPD-owned clinical research units (CRUs). Enhancing its ability to conduct complex Phase I and Phase Ib research in neurology, PPD has added a 52-bed CRU in Orlando, Fla. In addition, the company’s Las Vegas CRU, a hospital-adjacent, 24-bed unit specializing in endocrinology and metabolic trials, has expanded its portfolio to include the conduct of Japanese ethno-bridging studies.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.