Johns Hopkins Drug Commercialization Expert Looks at Controversy over Alzheimer’s Treatment

Johns Hopkins Carey Business School Senior Lecturer Supriya Munshaw – an expert in the commercialization of early-stage technologies, especially in the life science and medical device industries – offers her insights into the FDA’s rationale for approving the Alzheimer’s drug aducanumab, the price set by Biogen, the future of FDA leadership, and other related topics, in this Q&A.

Rutgers Pediatric Infectious Disease Expert Available to Discuss Pfizer’s Vaccine Approved by FDA for Children

Pediatric infectious disease expert David Cennimo is available to discuss the Food and Drug Administration approving Pfizer’s COVID-19 vaccine for emergency use on kids ages 12 to 15. “The Pfizer vaccine had a great track record of safety and success since…

Most dollars spent on top-selling orphan drugs don’t go to treat people with rare diseases

Pharmaceutical companies get special protection from the FDA for orphan drugs aimed at rare diseases, but a study shows high spending for common diseases for some such drugs. Just 21% of the total dollars spent in 2018 on 15 top-selling partial orphan drugs went to the treatment of rare diseases, while more than 70% went to the treatment of common diseases.

Seattle Cancer Care Alliance Selected as an Authorized Treatment Center for BreyanziTM/Liso-Cel CAR T-Cell Treatment

Seattle Cancer Care Alliance (SCCA), the only NCCN-designated cancer center in Washington State, has been selected as an authorized treatment center for the new chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel, also known as liso-cel and by the brand name BreyanziTM. Liso-cel was approved by the U.S. Food and Drug Administration (FDA) on February 5, 2021.

UCLA, UCSF gain FDA approval for prostate cancer imaging technique

The University of California’s two nationally ranked medical centers, UCSF and UCLA, and their nuclear medicine teams have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body to which the tumors have migrated.

Rutgers Vaccine Expert Available to Discuss Moderna’s FDA Submission

Rutgers’ principal investigator for the Moderna phase 3 coronavirus vaccine clinical trial at Rutgers New Jersey Medical School is available to discuss the drugmaker’s submission of its vaccine to the U.S. Food and Drug Administration for regulatory approval. “It is…

Alzheimer’s Association should reveal financial conflict of interest in urging FDA to approve Biogen drug, says Dr. Leslie Norins, CEO of Alzheimer’s Germ Quest

Biogen tried, and failed, to win FDA committee approval for its anti-amyloid Alzheimer’s drug. The Alzheimer’s Association supported the application but did not reveal significant monies received from the firm.

Redesigning Hand Sanitizer and Donating 7,000 Gallons to Fight Covid-19

Notice how hand sanitizer has made a comeback? It was running out, but this charitable initiative helped revive it by tapping into ethyl alcohol and FDA approval.