Vaccines
Generex Biotechnology Corporation, a leading healthcare company, has submitted a pre-IND briefing package to the FDA requesting regulatory guidance on the Phase I/II clinical trial protocol and clinical development plan for its Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine. The company aims to develop a "Complete Vaccine" that generates a
Vaccines
A groundbreaking coronavirus vaccine, mRNA-1273, developed by Moderna Inc. in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), has demonstrated robust immune responses against SARS-CoV-2 and raised no serious safety concerns in a phase 1 clinical trial. The vaccine, which uses genetic material to produce a protein
Vaccines
Preliminary results from a phase 1 trial of the investigational mRNA-1273 vaccine, designed to protect against SARS-CoV-2, have shown promising results in healthy adults. The vaccine was generally well-tolerated and prompted neutralizing antibody activity, which is essential for preventing the virus from entering human cells. The trial, supported by the
Vaccines
Novavax, Inc., a late-stage biotechnology company, has announced the enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX CoV2373. This trial is a significant step towards addressing the need for a vaccine in the fight against the global COVID-19 pandemic. The
Vaccines
Novavax, a biotechnology company, has announced the enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX-CoV2373. The trial, conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), aims to evaluate the safety and immunogenicity of the vaccine in approximately
Vaccines
Congressional leaders from the Black Caucus have issued a statement and letter to the National Institute of Health (NIH), Food and Drug Administration (FDA), and Department of Health and Human Services (HHS) Secretary Alex Azar, urging them to ensure diverse participation in COVID-19 vaccine trials. The leaders express concern that
Vaccines
The Regulatory Affairs Professionals Society releases a daily intelligence briefing, Regulatory Reconnaissance, that provides a comprehensive overview of the latest regulatory news and updates from around the world. The briefing highlights key developments in the pharmaceutical and medical device industries, including new product approvals, clinical trials, and regulatory policies. A
Vaccines
Global efforts to combat the COVID-19 pandemic have accelerated with the World Health Organization (WHO) reporting six novel coronavirus vaccines in clinical trials. Oxford University has joined the list of vaccine candidates published by the WHO, alongside Moderna Inc., Inovio Pharmaceuticals Inc., and Chinese companies Sinovac, CanSino Biological Inc., and
Vaccines
New Jersey Senators Cory Booker and Bob Menendez have urged 15 pharmaceutical companies engaged in COVID-19 related work to prioritize diversity in vaccine or trial development, citing the disproportionate impact of the pandemic on communities of color and other minority groups. The senators argue that comprehensive demographic and racial data
Pharmaceutical industry
Semafore Pharmaceuticals announced encouraging data from a Phase I dose-escalation trial of SF1126 in patients with relapsed and refractory myeloma. The novel small molecule inhibitor of PI3K and mTOR demonstrated significant suppression of the PI3K pathway in tumor cells at well-tolerated doses. The study is evaluating SF1126 administered as a
Pharmaceutical industry
Oxagen Limited, a drug discovery and development company, has announced the completion of recruitment for its double-blind, randomized, placebo-controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist. The study, initiated in mid-May 2009, involves 440 asthmatic patients with moderate persistent asthma who will be
Pharmaceutical industry
Investigators reported encouraging interim data from a Phase 2 clinical trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in patients aged 60-75 with untreated acute myeloid leukemia (AML). The study, presented at the 51st American Society of Hematology (ASH) Annual Meeting, compared CPX-351 to the conventional "7+3" therapy
