An FDA advisory panel voted on Tuesday to recommend emergency use authorization of a reduced dose of Pfizer/BioNTech's COVID-19 vaccine for children ages 5 to 11. The FDA could make a decision within days, and the CDC's vaccination advisers are scheduled to meet on Nov. 2 to discuss vaccination of younger children.
The CDC said in updated guidelines that certain people with weakened immune systems who have received three doses of an mRNA COVID-19 vaccine may be candidates for a fourth dose at least six months after receiving the third shot. The statement applies to moderately to severely immunocompromised adults, including those with untreated or advanced HIV, people who are undergoing treatment for tumors or blood cancers, those who have received certain transplants, and patients who take high doses of immunosuppressants.
As of Tuesday, the CDC said over 415 million COVID-19 vaccine doses have been administered in the US -- and almost 190.8 million Americans are now fully vaccinated. The agency also said that an estimated 13.8 million people have gotten a booster dose of the COVID-19 vaccines from either Pfizer/BioNTech, Moderna or Johnson & Johnson.
Precigen has received FDA clearance for its investigational new drug application for PRGN-3007, a chimeric antigen receptor T-cell therapy, to treat advanced hematologic cancers or solid tumors in breast cancers expressing receptor tyrosine kinase-like orphan receptor 1. Researchers used the company's UltraCAR-T therapeutic platform to develop the treatment.
Aduhelm was recently approved as a new drug for Alzheimer's disease, but while it was initially supposed to be for anyone with dementia, the FDA has now specified it for those with mild cognitive impairment. Some physicians question the narrower recommendation and if appropriate patients will be given the drug.
The Biden administration is working to repeal a rule issued during the Trump administration that accelerates Medicare coverage for some medical devices for Medicare beneficiaries, in a move supported by BIO. "The Medicare population is not homogenous and what existing clinical evidence may show to be 'appropriate' for a subset of patients for a given device or treatment may not be judged as 'appropriate' for the entirety of the vast array of all Medicare beneficiaries," BIO said.
Merck's new web series "Uncovering TNBC" features three Black women diagnosed with triple-negative breast cancer who discuss health disparities facing them and other Black women. Merck makes the only immuno-oncology therapy for triple-negative breast cancer and hopes to raise awareness about the aggressive cancer.
Mammoth Biosciences has announced an almost $700 million research and development deal with Vertex Pharmaceuticals that will focus on producing in vivo gene therapies that target two unnamed diseases using ultra-small CRISPR systems by Mammoth, Cas14 and Caso. The deal makes Mammoth eligible for an upfront payment of $41 million from Vertex, as well as approximately $650 million in milestones aside from tiered royalties.
The Avenio Tumor Tissue Comprehensive Genomic Profiling Kit, jointly developed by Roche and Foundation Medicine, has been launched to help labs broaden access for in-house oncology research. The kit uses a FoundationOne platform-based gene panel.
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Dole's Dole Diversified division has teamed with G-Berries, a new subsidiary of Italian berry supplier Molari Berries & Breeding, on a project to develop new fruit varieties in Mexico. "We define our approach as contemporary and tailor-made breeding," said G-Berries Managing Partner Luca Molari.
Archer-Daniels-Midland plans to use more than half of the corn feedstock it now puts into ethanol for cars to make sustainable jet fuel in partnership with Gevo. ADM is betting that electric vehicles and changed driving habits will reduce demand for auto fuel while airlines press for more available and more affordable low-emissions fuel.
Sanath, a determined father, used his software engineering skills to identify a potential 36 drugs to treat a rare genetic disease for his son. Sanath also founded a nonprofit, the Open Treatments Foundation, to further treatments for other rare genetic diseases. Watch now.
Vincenzo Piscopo, the president and CEO of the United Spinal Association, shares his own journey with a spinal cord injury. "Our organization needs to give people with disabilities opportunities to work and share their skillset, and stigmas are not allowed," Piscopo says. Watch now.
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at firstname.lastname@example.org.