AbbVie submitted a New Drug Application to the U.S. Food and Drug Administration for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

The U.S. Centers for Diseases Control and Prevention (CDC) on May 19 said reports of heart inflammation linked to the Pfizer/BioNTech COVID-19 vaccine have been much lower in 5- to 11-year-old boys than in adolescents and young men, representing only a slightly elevated rate than normal.

Novavax shared positive initial results from the Phase I/II clinical study of the company’s proposed combination vaccine for COVID-19.

Silverback Therapeutics is halting the company’s clinical oncology programs and letting go of about 27% of its workforce as part of a restructuring initiative that would leave Silverback with more cash reserves. 

The world’s first “human challenge” trial in which volunteers were deliberately exposed to the coronavirus has found that symptoms had no effect on how likely an infected person is to pass the disease on to others.

Sanofi

Sanofi and partner Swedish Orphan Biovitrum shared positive topline results from their ongoing Phase III trial on a candidate drug for patients diagnosed with severe hemophilia A. 

FDA

After Karyopharm Therapeutics Inc. submitted Phase III data from the Massachusetts-based pharmaceutical company’s SIENDO study on selinexor, the U.S. Food and Drug Administration said it was unlikely to support a supplemental New Drug Application approval for the drug.

Atara Biotherapeutics, an immunology-focused biopharmaceutical company based in San Francisco, announced a fatal serious adverse event (SAE) with a patient in a clinical trial at Memorial Sloan Kettering Cancer Center.

According to the U.S. Food and Drug Administration’s Adverse Events Reporting System (FAERS), three more deaths have been reported potentially associated with the Alzheimer’s drug Aduhelm since Biogen indicated during November 2021 that the company was investigating the death of a 75-year-old woman who died from a brain abnormality.

Legend Biotech’s clinical trial of the company’s candidate drug for relapsed or refractory T-cell lymphoma was placed on hold effective February 11 after some issues were raised on the first patient dosed.