In clinical trials, 33% of patients treated with Radicava showed a lower rate of decline in the loss of physical function, compared with those on a placebo.
As it named a new president, Diplomat reported Q2 results that showed increased revenue, but highlighted the margin pressure it’s seeing as the result of DIR fees.
Vyxeos combines two commonly used chemotherapies into a single formulation to treat patients with certain types of high-risk acute myeloid leukemia.
The single-tablet hepatitis C regimen is now approved for use in patients with hepatitis C that are co-infected with HIV.
The company’s pharmaceutical distribution services segment saw revenue of $37 billion, a 4.7% increase over the same quarter last year, with the AmerisourceBergen Drug Corp. seeing a revenue increase of 4.5% due largely to organic sales growth.
The bill contains the reauthorizations of the Food and Drug Administration’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.
The drug received priority review and breakthrough therapy designations, as well as orphan drug designation for this indication.
The Food and Drug Administration approved Nityt on Aug. 1 to treat the rare disease hereditary tyrosinemia Type 1, or HT-1, in combination with dietary restriction of tyrosine and phenylalanine.