Petitioners seeking the use of “march-in” rights to obtain lower pricing on Astellas’s prostate cancer drug Xtandi (enzalutamide) may not have been successful in their appeal, but did obtain HHS…
Consistent open communication and complete public transparency is the only way to counteract scientific misinformation, which is a considerable threat to public health today, said Kimberlee Trzeciak, deputy chairman of…
When questioned by senators in a hearing Thursday about why Americans pay exponentially more for many brand name drugs than residents of other countries, pharmaceutical company CEOs repeatedly pointed to…
The FDA has issued a draft guidance on how and when applicants and manufacturers should provide information on interruptions or discontinuations of drugs, biological products and active pharmaceutical ingredients to…
This edition of interesting device approvals and clearances includes a pulsed field ablation system, a transesophageal echocardiography ultrasound transducer, a digital cytology system that combines deep-learning-based AI, and a deep…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has proposed waiving certain requirements for biosimilars on “solid” evidence of quality comparability. Source: Drug Industry Daily
Vanda Pharmaceuticals is once again suing HHS and the FDA, claiming that the agencies are using regulatory process to accomplish an “end run” around the timetable required by law in…
The FDA’s Office of Clinical Pharmacology (OCP) conducted more than 5,600 reviews of investigational new drug (IND) submissions in 2023, helping determine correct dosing for 55 new drugs and biological…
The Federal Trade Commission (FTC) has waded into the march-in rights fracas, supporting the obscure Bayh-Dole Act as a tool to moderate drug pricing and control patent thickets on drugs…
Rather than trying to predict which medical devices could be in short supply during a national emergency, the FDA should focus on identifying those that are “mission critical” to patient…