News Wire

Two cancer trials involving atezolizumab (Tecentriq, Genentech) have been placed on partial clinical hold by the FDA as the regulatory agency continues to examine potential dangers of checkpoint inhibitors following deaths associated with pembrolizumab (Keytruda, Merck) earlier this summer, according…
Immune-cell–based therapies opening a new frontier for cancer treatment carry unique, potentially lethal side effects that provide a new challenge for oncologists. A team led by clinicians at The University of Texas MD Anderson Cancer Center is addressing that issue by proposing guidelines for systematically…
Primary care physicians (PCPs) spend more than six hours entering data into electronic health records (EHRs) during a typical day, which usually lasts 11.4 hours, according to a study by the University of Wisconsin and the American Medical Association (AMA). AMA officials were quick to point out that…
With the United States in the grip of an opioid epidemic, many insurers limit access to pain medications that carry a lower risk of addiction or dependence, according to an investigation by ProPublica and The New York Times. But insurers often provide comparatively easy access to generic opioid medications.…
Patients with hard-to-treat chronic lymphocytic leukemia (CLL) lived longer without disease progression when treated with a combination of venetoclax (Venclexta, AbbVie/Genentech) and rituximab (Rituxan, Biogen/Genentech) than when treated with a combination of bendamustine and rituximab, a new study…
The FDA has approved secnidazole (Solosec, Symbiomix Therapeutics) 2 g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Secnidazole is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that…
Lanreotide injection (Somatuline Depot, Ipsen Biopharmaceuticals, Inc.) 120 mg has received FDA approval for a new indication: the treatment of carcinoid syndrome. When used, it reduces the frequency of short-acting somatostatin analog rescue therapy. The medication, a somatostatin analog, is also approved…
Reversing an earlier decision to exit the Virginia ACA marketplace, Anthem announced that it will sell insurance in 68 counties and cities in the state next year. The decision means that all counties in the country will be covered, Reuters reports. “Earlier this week, a spokesperson for Virginia’s…
It’s not just that insurers make it easier for people to obtain addictive opioids than more expensive, but non-addictive counterparts, it’s also that they’ve erected hurdles to addiction treatment, according to a jointly reported article by the New York Times and Pro Publica. HHS is looking into…
The FDA has approved Mvasi (bevacizumab-awwb, Amgen/Allergan) as a biosimilar to Avastin (bevacizumab, Genentech) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. Mvasi is approved for the treatment of adult patients with…
An FDA advisory panel has voted 11-0 that the safety and efficacy of GlaxoSmithKline’s (GSK) Shingrix shingles vaccine warrants approval for its use in adults 50 years of age and older. Panel members said they were “very impressed” by efficacy data from Shingrix clinical trials, and that it represents…
The FDA has approved a supplemental new drug application expanding the indication for eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) to include treatment of partial-onset seizures (POS) in children and adolescents 4 to 17 years of age. Eslicarbazepine is also approved in the U.S. for the…
Privigen (immune globulin intravenous [human], 10% liquid, CSL Behring) has received FDA approval for an additional indication: the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. CIDP is a rare autoimmune disorder that affects the…
The FDA has permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application (Pear Therapeutics) is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana, and stimulant SUDs. The application is not intended to be…
The FDA has granted accelerated approval to copanlisib (Aliqopa, Bayer Healthcare Pharmaceuticals) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often comes back even…

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