Target $27
Friday, July 12, 2019
AstraZeneca Imfinzi gets US Orphan Drug Designation for small cell lung cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC).
SCLC constitutes about 15% of all lung cancer diagnoses. It is the most aggressive type of lung cancer with only 6% of patients alive after five years. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
In June 2019, the Phase III CASPIAN trial met its primary endpoint with Imfinzi by showing a statistically-significant and clinically-meaningful improvement in overall survival for patients with extensive-stage SCLC. These patients were treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy vs. chemotherapy alone. Results will be shared at a forthcoming medical meeting. Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.
Gilead, Renown Institute in NASH Collaboration
Gilead Sciences, Inc. (Nasdaq: GILD) and the Renown Institute for Health Innovation (IHI) today announced a strategic collaboration to collect and analyze genetic and electronic health data that can enhance the understanding of nonalcoholic steatohepatitis (NASH) and potentially inform development of treatment options for the disease.
Under the terms of the collaboration and license agreement, Gilead will provide funding to Renown IHI to sequence and analyze the DNA of 15,000 individuals living with NASH or nonalcoholic fatty liver disease (NAFLD) as well as a control cohort of 40,000 individuals in Nevada.
‘Combining the sequencing of protein coding DNA, with extensive electronic health record data will enable a deep analysis of the roles of genetics and environment in NASH incidence and progression,’ said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. ‘The analysis of these large datasets in collaboration with Renown IHI could help identify genetic variants that impact the risk of developing NASH and thereby advance the discovery and development of new treatments for this disease.’
Renown Health is Nevada’s most comprehensive and integrated healthcare network and maintains electronic health records for 1.02 million registered patients. In 2016, Renown Health and the Desert Research Instituteestablished the Healthy Nevada Project (HNP), the nation’s first community-based population health study. In 2017 HNP began a partnership with Helix to leverage its population health services, Exome+ sequencing, and consumer engagement tools. The HNP is now an ongoing collaboration between Renown IHI, the Desert Research Institute, a global leader in environmental data and applied research, and Helix, a personal genomics company. HNP combines genetic, environmental, social and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The HNP currently has 40,000 participants.
Glenmark, Torrent Pharma in licensing pact
Glenmark Pharmaceuticals Limited and Torrent Pharmaceuticals Limited have announced the signing up of a licensing agreement for co-marketing diabetes drug Remogliflozin Etabonate in India. In terms of the agreement, Glenmark will get an upfront payment, licence fees and royalties for the non-exclusive sub-licence rights from Torrent.
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