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11

U.S. FDA authorizes Pfizer’s COVID booster shot for young children

The U.S. Food and Drug Administration on May 17 authorized the use of a booster shot of Pfizer and BioNTech’s COVID-19 vaccine for children aged 5 to 11, making everyone in the United States over the age of 5 eligible for a third shot.

12

Strategies to Increase Diversity in Rare Genetic Disease Trials

Diversity in all clinical research—including rare disease research—is currently under scrutiny, partly because of disparities experienced with COVID-19. Rightly so, as data show that 86 percent of genomics studies to date have involved people of European ancestry, which has limited the potential benefits of genomic research for many populations. Rebecca Sutphen, Co-Founder and Chief Medical Officer of InformedDNA, and Board-Certified Genetic Counselor Karmen Trzupek analyze strategies to increase diversity in rare genetic disease trials.

13

New Retrospective Data on African Americans with Advanced Symptomatic Sarcoidosis Treated with Acthar Gel Presented at the American Thoracic Society Annual International Conference

Global biopharmaceutical company Mallinckrodt plc announced results of a retrospective, observational medical chart review subgroup analysis assessing real-world treatment outcomes among African Americans with advanced symptomatic sarcoidosis who initiated therapy with Acthar Gel (repository corticotropin injection).

15

FDA authorizes COVID-19 boosters for kids 5-11 as cases creep up

On May 17, the U.S. FDA authorized a booster of Pfizer’s vaccine for kids ages 5 to 11 years. The action comes as major cities are announcing a rise in cases. Additionally, COVID-19 would have claimed over 110,000 more lives in 2021 if not for the Pfizer-BioNTech vaccine, according to a Pfizer-sponsored report on the first year of the U.S. vaccination program.

19

Baby formula makers ramp up U.S. supplies to tackle shortage

Top baby formula makers Reckitt Benckiser and Nestle ramped up supplies to the United States to resolve a shortage that has emptied shelves and caused panic among parents. Leading U.S. manufacturer Abbott Laboratories on May 16 announced an agreement with the Food and Drug Administration to resume production of baby formula at the company’s Michigan plant, marking a major step towards resolving the nationwide shortage.

20

AstraZeneca boosts COVID portfolio with RQ Bio deal

AstraZeneca moved to bolster the company’s COVID-19 portfolio of antibodies on May 17 with a $157 million licensing deal for experimental therapies developed by newly launched biotech RQ Bio.