News Notes

December 1, 2019

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2019, Volume 28, Issue 12

A compilation of recently released news briefs that pertain to the clinical trials industry.

Lilly Revamps Its Cancer R&D Unit

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 makes major acquisition

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.

AD biomarkers repository launched

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 to buy Rodin Therapeutics

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 strikes stem cell pact

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 bolsters its early development

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.

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