Johnson & Johnson gears up for 60,000-person COVID vaccine trial, the industry's biggest yet CDC director warns of major public health complications if public doesn't take flu and COVID-19 seriously Trump administration revokes FDA authority over lab-developed tests, including some COVID-19 diagnostics Pfizer, BioNTech share clinical data linking favored COVID-19 vaccine to improved tolerability Survey finds nearly half of Americans having insurance coverage troubles Outsmarting COVID-19 and other viruses by analyzing RNA in single cells Brigham and Women's taps mental health startup to use AI to track providers' stress Healthcare roundup: Morehouse, UnitedHealth team on sickle cell study Biopharma roundup: Pfizer, BioNTech on track for October vaccine review; HHS axes need for FDA approval on COVID-19 tests Virtual trial specialist and Big Pharma-backed Science 37 nabs $40M funding round Featured Story | By Eric Sagonowsky With several COVID-19 vaccines already in phase 3 trials and investigators aiming to enroll tens of thousands of participants, Johnson & Johnson is prepping the largest study so far. The pharma giant aims to enroll a whopping 60,000 participants—twice as many as rivals Moderna and Pfizer—in a phase 3 trial set to begin next month. read more |
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Top Stories By Robert King The Centers for Disease Control and Prevention is scrambling to ensure confidence in and enough supplies of a flu vaccine as fall and winter approaches and COVID-19 is still spreading in the U.S. read more By Conor Hale The Trump administration has revoked the FDA’s authority over lab-developed tests, including requirements that diagnostics made for COVID-19 go through the agency’s emergency review and authorization process. read more By Nick Paul Taylor Pfizer and BioNTech have published clinical data on the COVID-19 vaccine they advanced into phase 3. The early clinical data link the phase 3 candidate to a far lower rate of adverse events than another prospect, explaining Pfizer and BioNTech’s decision to move it into late-stage testing. read more By Robert King Nearly half of Americans in a new survey reported either being uninsured or underinsured, an issue that could worsen as the COVID-19 pandemic continues to wreak havoc on the economy. read more By Arlene Weintraub Scientists at Rutgers University have developed a technique that uses light to detect changes in RNA at the single-cell level. The method could be used to track the evolution of SARS-CoV-2 and perhaps help solve mysteries such as why some people are super-spreaders of the virus and others are not. read more By Heather Landi Brigham and Women's Hospital has tapped mental health startup Rose to help support clinicians' mental health during the COVID-19 pandemic. Rose uses artificial intelligence and natural language processing to detect early warning signs of mental health conditions including anxiety, depression and trauma. read more By Healthcare Staff Follow along with the latest COVID-19 news straight from the Fierce Healthcare team. read more By Eric Sagonowsky, Angus Liu, Kyle Blankenship, Conor Hale, Fraiser Kansteiner Pfizer and BioNTech are on track to seek vaccine review in October. HHS said some COVID-19 tests don't need FDA approval. The agency's Peter Marks said he would resign if politics push a shot through review, plus two lawmakers called for more financial transparency from vaccine maker Moderna. read more By Ben Adams Novartis, Amgen, Sanofi, PPD and Google’s VC arm are just a few of the big names backing California’s “siteless” trial expert Science 37’s $40 million funding round. read more |
