The FDA has cleared a new auricular neurostimulation device (Drug Relief, DyAnsys, Inc.), to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics. The device is available for providers to prescribe for use during opioid detoxification. The wearable device sends electrical…
The FDA has approved the use of daratumumab (Darzalex, Genmab) in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The supplemental biologics license application…
It seems as if reports of the ACA’s demise have been greatly exaggerated. The Wall Street Journal reports today that after years of pulling out of the Obamacare marketplaces, health insurance plans have started to re-enter. That’s in part because the health plans are starting to make money because…
In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Scott Gottlieb, MD, wants to speed approval times for rivals to promising new first-to-market medicines, Reuters reports. The FDA chief has made a commitment to speeding up approvals of cheap generic medicines,…
The FDA has approved pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. The indication is approved under the FDA’s accelerated approval regulations…
Flushing the bladder with gemcitabine—a common chemotherapy drug—immediately after surgery significantly reduces the chances of bladder cancer returning, according to a major study led by Edward M. Messing, MD, and an international clinical trials network (SWOG) funded by the National Cancer Institute…
The FDA has approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and is BRAF V600E mutation-positive. Both drugs are Novartis products.…
A new discovery shows that opioids used to treat pain, such as morphine and oxycodone, produce their effects by binding to receptors inside neurons, contrary to conventional wisdom that they acted only on the same surface receptors as endogenous opioids, which are produced naturally in the brain. However,…
The FDA has permitted marketing of Hemospray (Wilson-Cook Medical, Inc.), a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. “The device provides an additional nonsurgical option for treating upper and lower GI bleeding in certain patients and may help…
If there’s one thing I’m a sucker for it’s a good spit quote, so I perked up when reading this: “The marketplace has been happy to respond to this fascination with genetic navel gazing, offering consumers a growing number of genetic screening tests that allows them to spit into a tube and learn…
The FDA has approved erenumab-aooe (Aimovig, Amgen, Inc.) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Erenumab is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin…
The FDA has approved an expanded indication for fingolimod (Gilenya, Novartis) to treat relapsing multiple sclerosis (MS) in children and adolescents 10 years of age and older. This is the first FDA approval of a drug to treat MS in pediatric patients. “For the first time, we have an FDA-approved…
The FDA has approved lofexidine hydrochloride (Lucemyra, US WorldMeds LLC) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While lofexidine may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for…
Days after President Donald Trump delivered a speech on prescription drug prices that was notably light on criticism of the pharmaceutical industry, his health secretary on Monday struck a far more aggressive tone, warning that the administration would be “turning on the pressure” on drug makers,…
The FDA has approved Retacrit (epoetin alfa-epbx, Hospira, Inc.) as a biosimilar to Epogen (epoetin alfa, Amgen, Inc.) and Procrit (epoetin alfa, Janssen) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with human immunodeficiency virus infection.…
