Loxo Oncology granted Bayer development and global commercialization rights to cancer candidates LOXO-101, or larotrectinib, for adult and pediatric patients with unresectable or metastatic solid tumors with NTRK-fusion proteins, and LOXO-195, which is in Phase I/II trial for patients with cancers that have acquired resistance to initial tropomyosin receptor kinase treatment. The deal gives Loxo $400 million upfront and $1.2 billion in milestones, plus royalties.
The FDA approved a formulation of Otsuka Pharmaceutical's mental health drug Abilify that contains a tracking device developed by Proteus Digital Health. The device is activated by stomach juices and sends a signal to a wearable patch, which transmits data to a smartphone application, in an effort to help with medication regimen compliance.
Juno Therapeutics presented a report at the Society for Immunotherapy of Cancer conference last week discussing its findings on the deaths of five patients with advanced acute lymphoblastic leukemia that occurred during the clinical trial for the company's chimeric antigen receptor T-cell therapy candidate. The report indicated that the deceased patients, who already had higher-than-average levels of the inflammatory cytokine IL-15 before infusion, experienced even higher IL-15 numbers after the treatment, causing severe brain swelling and death.
The medical device industry's strategy to ensure cybersecurity of its products involves collaboration with regulatory agencies, health care providers, industry partners and other stakeholders to address security loopholes while raising the standards of security for all stakeholders, writes AdvaMed President and CEO Scott Whitaker. In addition to following cybersecurity regulations, the medical device industry has also established an information sharing and analysis organization and has adopted its own cybersecurity principles to help manufacturers develop cybersecurity programs based on FDA guidance and other best available information, he writes.
AstraZeneca's Fasenra, or benralizumab, was approved by the FDA as an add-on maintenance treatment for severe eosinophilic asthma in patients at least 12 years old. The company intends to market the drug in the next several weeks.
President Donald Trump announced Monday that he is nominating Alex Azar, a former Eli Lilly and Co. executive and HHS deputy secretary during President George W. Bush's administration, to serve as the next HHS secretary. The nomination was praised by Republican lawmakers, as well as industry trade groups AHIP and PhRMA, but several Democrats and health policy experts questioned Azar's ties to the pharmaceutical sector and raised concerns on whether he can fairly implement measures to lower pharmaceutical profits.
Immersive experiences can recreate almost any environment or workplace, and artificial intelligence can help find the best candidates from thousands of job applicants. With respondents to Aon's 2017 Global Risk Management Survey citing "disruptive technologies/innovation" such as virtual reality and AI as an "emerging risk" -- one predicted to be in the top 10 list of risks in just a few years -- it becomes clearer that forward thinking about how best to use these technologies is a growing priority for business leaders. How are VR and AI helping transform our world of work? Read more.
Aon Global Risk Consulting, the risk consulting business of Aon, in collaboration with the Wharton School of the University of Pennsylvania, has released its fifth edition of the Aon Risk Maturity Index Insight Report, or RMI. Report findings reinforce previous RMI research, which reveals a direct relationship between strong risk management practices and superior operating performance for organizations. New this year, the report uncovered a relationship between improved Directors and Officers premiums and risk maturity. Download the report.
Aon provides Life Sciences companies with end-to-end risk solutions, supporting organizations from the initial discovery phase to final product launch. The practice provides solutions across the Life Sciences for pharmaceutical manufacturers; generic and OTC pharmaceutical companies; biotechnology and biopharmaceutical companies; genomic and proteomic companies; drug delivery system; diagnostic substance companies; and medical device and equipment manufacturers.
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