What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine

ScienceNews: February 27, 2021. On February 27, the FDA authorized Johnson & Johnson’s COVID-19 vaccine for use in the U.S. The other two authorized vaccines are made by Pfizer and Moderna. None are FDA approved. All show effectiveness, but there are too few serious COVID-19 cases in any of the studies to conclude how well it prevents hospitalizations or deaths.

Read More »

J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel

Medscape Medical News: February 26, 2021. An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine, but several researchers expressed concerns to the panel about the lower standards of EUAs, including NCHR’s president Dr. Diana Zuckerman.

Read More »

Who Will Be the Next F.D.A. Chief?

The New York Times: February 20, 2021. One month into his presidency, President Biden still has not named a candidate to head the Food and Drug Administration, a critical position at a time when new vaccines and coronavirus treatments are under the agency’s review. This has spurred a public lobbying campaign by supporters of the two apparent front-runners, Dr. Joshua Sharfstein, a former high-ranking F.D.A. official and Dr. Janet Woodcock, the acting commissioner.

Read More »

FDA blasts Merck’s Keytruda data for new breast cancer indication

Stat News, February 5, 2021. The cancer drug Keytruda is a medical and financial juggernaut, but it may not win FDA approval for early-stage triple negative breast cancer. FDA medical reviewers agreed there is a need for new treatments, but Keytruda did not impress them with its small benefit of “questionable clinical meaningfulness” and serious safety issues. NCHR’s Dr. Zuckerman said “This is one of the most negative reviews I’ve ever seen.”

Read More »

Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL

Cancer Therapy Advisor, February 8, 2021. Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field, including Dr. Diana Zuckerman of the National Center for Health Research and their Cancer Prevention and Treatment Fund.

Read More »