J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval Roche, AC Immune's tau-blocking drug flops in Alzheimer's as biotech's shares halved FDA to set high bar for emergency COVID-19 vaccine approvals Silverback Therapeutics nets $85M top-up to push lead ADC through phase 1 4th time's the charm: Longitude Capital raises $585M in its largest-ever fund Childhood cancer-focused Day One snags Gilead alum Bender for CEO FDA launches digital health-focused center of excellence New insights into the coronavirus spike protein could inspire vaccine development Featured Story | By Nick Paul Taylor Johnson & Johnson has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year. read more |
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| | In our recent 90 Second Insight video, WCG ThreeWire's Molly Hair, Director of Site Engagement and Management, discusses how study staffing shortages due to COVID-19 are affecting clinical research in oncology. Visit wcgclinical.com to see how our Site Support and Augmentation Services can get your oncology trial back on track. |
Top Stories By Ben Adams Blocking tau appears to be just as fruitless as clearing amyloid buildup when it comes to helping Alzheimer’s disease patients. read more By Nick Paul Taylor The FDA is set to take a tough line on the evidence required to support emergency use authorization (EUA) of COVID-19 vaccines, according to The Washington Post. The reported requirements suggest a company is unlikely to have the data needed to support an EUA before the election in six weeks. read more By Amirah Al Idrus After banking $78.5 million in March, Silverback Therapeutics is back for more. The company is picking up another $85 million to advance its lead program through the clinic and to develop its earlier-stage pipeline. Unlike other antibody-drug conjugates designed to kill cancer cells, Silverback is working on treatments that ramp up the immune response to cancer. read more By Amy Sokolow The co-founders and co-managing directors of Menlo Park, Greenwich Village and Boston-based healthcare venture capital firm Longitude Capital invest in areas they hope will increase life expectancy and quality of life for patients suffering from cancer, neurodegenerative diseases, orphan diseases, aging and more. read more By Amirah Al Idrus Day One Biopharmaceuticals emerged in May to develop new drugs specifically for children with cancer. Now, as it ramps up its work, the company is making a flurry of new hires and new board appointments, including a new CEO: Jeremy Bender, Ph.D., who previously led corporate development at Gilead Sciences. read more By Conor Hale The FDA has launched a new center of excellence to oversee digital health products such as smartphone apps, wearable devices and software-based treatments. read more By Angus Liu A team led by scientists at the University of California, San Diego focused its COVID-19 research on glycans, which are sugar molecules that shield the virus's spike protein. The researchers revealed an essential role of N-glycans at two sites on SARS-CoV-2 they say offers a novel pathway for vaccine development. read more Resources Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. 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