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The FDA cited over-the-counter (OTC) drug manufacturer Eosera for failing to conduct process validations and other lapses at its Fort Worth, Texas facility. Read More
Teva Pharmaceuticals will be front and center in the first bellwether trial over an alleged industrywide generic drug price fixing conspiracy, a federal judge for the U.S. District Court for the Eastern District of Pennsylvania has ruled. Read More
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-7 on Wednesday to support approval of Mallinckrodt’s terlipressin for treatment of hepatorenal syndrome type 1 (HRS-1), a life threatening kidney condition in patients with advanced liver disease. Read More
The House Energy and Commerce Committee approved five measures that would address orphan drugs, generic drugs, drug safety and drug manufacturing during a virtual markup yesterday, sending them to the full House. Read More
Roche has signed a $1.7 billion agreement with Blueprint Medicines to develop and commercialize Blueprint’s pralesetinib for treatment of patients with RET-altered cancers. Read More
The FDA said yesterday that it has reviewed more than 230 clinical trials of potential COVID-19 treatments so far through its Coronavirus Treatment Acceleration Program (CTAP). Read More