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Makers of connected medical devices should brace themselves for more FDA enforcement — warning letters, inspections, demands for information and untitled letters — as the digital health space unfolds and evolves, says a former Justice Department prosecutor. Read More
Bluebird Bio is pulling out all the regulatory stops for its investigational sickle cell disease (SCD) gene therapy lovotibeglogene autotemcel (lovo-cel), submitting a BLA with a request for priority review in addition to the four expedited approval designations the FDA had already granted the drug. Read More
The FDA has deemed Avanos Medical’s Feb. 22 recall of certain Ballard Access closed suction ventilation devices as Class I, the most serious type of recall, as using these devices may cause serious injury or death. Read More
The latest devicemaker to follow an important FDA pathway for technological innovation in devices is French company UroMems, which has snagged a Safer Technologies Program (STeP) designation for its UroActive Smart Continence Therapy device. Read More
The European Medicines Agency (EMA) has become the first regulator to accept the International Council for Harmonization (ICH) S12 guideline, laying out the council’s recommendations for how to conduct nonclinical biodistribution (BD) studies when developing gene therapy products. Read More
More than half of the best-selling brand-name drugs covered by Medicare may not provide significant added therapeutic benefits despite comprising a large portion of the federal agency’s spending, according to results of a study published in JAMA Network this week. Read More
Over the past week, the FDA issued a correction of a docket, an authorization and two revocations of diagnostic devices and a request for comments on rapid response surveys. In addition, the agency announced a public workshop. Read More
mRNA developer Moderna and computer giant IBM have announced an agreement under which Moderna will explore next-generation technologies, including quantum computing and artificial intelligence (AI), to accelerate mRNA research and science. Read More
GenBioPro, the only U.S. maker of the generic version of the abortion pill mifepristone, has sued the FDA, HHS and DOJ in an effort to protect the company from regulatory action that could withdraw or limit FDA approval of its drug based on recent court rulings. Read More
The FDA’s latest proposed trial design for evaluating the effectiveness of opioids as chronic pain treatments was met with backlash from pain management and anesthesiology experts who contend the protocol is flawed on multiple fronts. Read More
Genentech has won full approval for its first-in-class combination therapy aimed at providing curative treatment for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma in the U.S. Read More
Before the passage of the Orphan Drug Act (ODA) in 1983, the logistical challenges and financial downsides of developing a drug for a very small population affected by a rare disease meant few drugs on the horizon. Read More