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 – The list is out, and a dual-acting osteoporosis drug and a device for expanding the use of minimally invasive mitral valve surgery have come out on top.

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.

There’s a yin and yang to neoantigens, Alberto Bardelli told the audience at the 2019 annual conference of the European Society of Medical Oncology (ESMO) in Barcelona, Spain, last month.

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.

WASHINGTON – A little more than a year after first reporting phase IIb results showing oral TORC1 inhibitor RTB-101 reduced the number of respiratory tract infections (RTIs) in older adults, Restorbio Inc. is illuminating what may be the mechanism behind its efficacy: the up-regulation of innate antiviral immunity. The data, presented at the Infectious Disease Society of America's IDWeek 2019, put the company on track to move into two phase III data readouts next year. 

BOSTON – Panelists at Biopharm America debated strategies for early stage financing as they weighed the importance of a prestigious board, the wisdom of small deals by startups with pharma firms, and the likelihood (or not) that angel investors will help make the case with other backers yet to come.