COVID-19 vaccines
The Oxford-AstraZeneca vaccine, which is currently in phase two trials, has demonstrated safety and an immune response similar to younger groups among all adults, including those over 70. This has raised hopes that the vaccine can protect age groups most at risk from COVID-19. The trial results suggest that the
Vaccines
The National Institutes of Health (NIH) and Moderna, Inc. have announced that their joint Phase 3 trial of the mRNA-1273 vaccine candidate has produced promising results, with an interim analysis suggesting that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The data, reviewed by an independent
Vaccines
Bhubaneswar, Nov 16 -- Hyderabad-based vaccines and pharmaceutical company Biological E Ltd (BE) has initiated clinical trials for its Covid-19 subunit vaccine candidate in the country after receiving approval from the Drugs Controller General of India (DGCI). The vaccine candidate is developed in collaboration with Dynavax Technologies Corporation and Baylor
Vaccines
PDS Biotechnology Corporation has announced the opening of its VERSATILE-002 Phase 2 clinical trial for the treatment of head and neck cancer that has returned or spread. In collaboration with Merck, the trial will evaluate the efficacy and safety of combining PDS0101, a Versamune-based immunotherapy targeting human papillomavirus (HPV)-associated
Vaccines
The Regulatory Affairs Professionals Society releases its daily regulatory news and intelligence briefing, Regulatory Reconnaissance, which covers key developments in the regulatory affairs space. The briefing summarizes various news stories related to the pharmaceutical and medical device industries, including trials, approvals, and updates on the COVID-19 pandemic. Notable news includes
Vaccines
Inovio Pharmaceuticals' development of its COVID-19 vaccine candidate, INO-4800, has hit a roadblock as the U.S. Food and Drug Administration (FDA) has put the Phase II/III trial on partial clinical hold, citing additional questions about the vaccine and its delivery device, the Cellectra 2000. This move comes
Vaccines
INOVIO Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has put its planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800 on partial clinical hold, citing additional questions about the company's delivery device, CELLECTRA 2000. Despite this setback, INOVIO is actively
Vaccines
With the US surpassing 200,000 deaths due to COVID-19, a group of pediatric infectious disease specialists is urging the acceleration of vaccine trials for children. The specialists warn that the current pace of vaccine development for adults is not translating to progress in pediatric trials, leaving children "stuck
Vaccines
In a sudden move, the U.S. Centers for Disease Control and Prevention (CDC) removed new guidelines from its website suggesting that the new coronavirus can be transmitted by tiny droplets over a distance greater than six feet. The updated guidelines, which were posted on Friday but removed on Monday,
Vaccines
Pfizer, in partnership with German biotechnology company BioNTech, aims to expand its Phase 3 clinical trial for its COVID-19 vaccine, with plans to enroll 44,000 participants and include a more diverse population. This move is seen as a step towards ensuring the vaccine's safety and efficacy in
Vaccines
Pfizer Inc and BioNTech SE have proposed to the US Food and Drug Administration (FDA) to expand their Phase 3 pivotal COVID-19 vaccine trial to approximately 44,000 participants, increasing the diversity of the trial population. The initial target of 30,000 participants is expected to be reached by next
Vaccines
British drugmaker AstraZeneca has kicked off Phase 3 trials of its experimental coronavirus vaccine in the United States, making it the third company to initiate late-stage trials of a vaccine aimed at preventing COVID-19. AstraZeneca's vaccine, developed in partnership with Oxford University, has received backing from the US
