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CDER’s Office of New Drugs (OND) Director Peter Stein is a nationally recognized leader in pharmaceutical research and development. Before joining the FDA in 2016 as OND deputy director he was a vice president at Merck Research Laboratories and formerly a vice president at Janssen. Read More
The White House said Thursday that it will ask the U.S. Supreme Court to step in to defend the FDA’s 22-year-old decision to approve the abortion drug mifepristone after an appeals court denied the Justice Department’s request to allow full access to the drug on Wednesday. Read More
Bluebird Bio’s lovotibeglogene autotemcel (lovo-cel) and Vertex Pharmaceuticals’ exagamglogene autotemcel (exa-cel) gene therapies for severe sickle cell disease (SCD) would probably be cost-effective if priced around $2 million, according to a draft review by the Institute for Clinical Evaluation and Research (ICER). Read More
Arbutus Biopharma — which has been going after makers of the two messenger RNA (mRNA)-based COVID-19 vaccine makers alleging patent infringement — suffered a loss this week when a U.S. appeals court affirmed a decision to cancel its patent related to Moderna’s vaccine. Read More
Multiple devices and digital behavioral interventions have been approved or are in the works to help patients suffering from opioid use disorder (OUD), says FDA Commissioner Robert Califf, but obstacles such as a high failure rate and proof of efficacy stand in the way of wider adoption. Read More
The drug candidate is being evaluated in a phase 1 study in patients with advanced metastatic or progressive solid tumors who are either resistant to or can’t tolerate the standard therapy. Read More
The FDA offers expanded advice for sponsors on risk-based monitoring of clinical trials in a new final guidance that updates the agency’s previous guidance on the topic issued in 2013. Read More
While Congress may have ended the “national emergency related to the COVID-19 pandemic” with a joint resolution President Biden signed into law on Monday, the public health emergency (PHE) declared by HHS Secretary Xavier Becerra will remain in effect another month. Read More
Right now, the dual orexin receptor antagonist class of chronic insomnia medications is a scheduled class under the Controlled Substances Act. Read More
As two dueling lawsuits over the FDA-approved medical abortion drug mifepristone appear headed to the U.S. Supreme Court, hundreds of drugmakers say Friday’s ruling in the Texas case is an overstep that could weaken the federal agency and hamper future drug development. Read More