BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld. "I'm not going to call it the gold standard." Some of the reasons for denying biopsies a gold sticker are obvious. Biopsies are invasive, which makes them risky, expensive and loathed by patients and doctors alike. "In the real world, doctors don't always do biopsies – many say they very rarely do biopsies unless other data points in several directions and they need that for clarity," Gail Cawkwell told BioWorld.
CLEVELAND Patents took center stage on the final morning of Cleveland Clinic's Medical Innovation Summit, with two experts shedding some light on the issues surrounding patentability particularly in light of recent legal cases and a hearing before a subcommittee of the Senate Judiciary Committee.
SAN FRANCISCO Investor sentiment around Biogen Inc.'s plan to soon seek approval for aducanumab in Alzheimer's disease yielded a clear bold reaction in its rising share price Tuesday. But a more nuanced reading was floated during a CNS panel at the BIO Investor Forum the day after, where a focus on new modalities and a call for open-mindedness carried the conversation. "It almost doesn't matter what investors think," said Ellen Lubman, a panelist and chief business officer of Impel Neuropharma Inc. "The reality is that if truly there's a percentage of people getting a benefit from the drug... that's the reason we're all in this business."
SAN FRANCISCO At what BIO CEO and President Jim Greenwood called a "Dickensian moment in the history of biotechnology arguably the best of times and the worst of times" for U.S. industry players, new rules piloted by the Committee on Foreign Investment in the U.S. (CFIUS) have made things even more challenging. Confusion about CFIUS has led to a decline in Chinese venture capital investment in U.S. biotech and, at some firms, even a pause in cross-border investment as they wait for the dust to clear, experts said.
CLEVELAND What are some of the biggest challenges related to using artificial intelligence (AI) in health care? A panel of experts tackled that question during a session Tuesday during the 2019 Medical Innovations Summit, while also discussing what their organizations have done in that space to advance patient care.
CLEVELAND Monday featured a big announcement during the 2019 Medical Innovation Summit, with the Cleveland Clinic and American Well revealing that they are partnering to create a joint venture (JV) focused on telehealth.
WASHINGTON – In case any question remained about who shoulders the blame for the serious lack of viable innovation in the infectious disease specialty, a panel at the Infectious Disease Society of America's IDWeek 2019 came with a surprisingly accusatory subtitle: "How ID Killed Antibiotic Development." Observing what Vivo Capital Managing Partner Chen Yu called "an existential crisis for the specialty," the session served as a call for action for infectious disease (ID) doctors to take control of prescribing, put patient care ahead of cost management, and advocate for both faster changes to clinical guidelines and legislative improvements to better position the industry.
WASHINGTON – Hot on the heels of July's FDA approval of Recarbrio (imipenem, cilastatin and relebactam) in complicated urinary tract infections (cUTIs), Merck & Co. Inc. rolled out pivotal phase III data at the Infectious Disease Society of America's IDWeek 2019 that could support expanding its label to another high-need group, people with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). Shionogi & Co. Ltd., which is advancing its investigational antibiotic, cefiderocol, in the same indications, also shared new phase III data supporting its use in the high-risk population.