News

A large prospective study of the use of Rituxan (rituximab) and a biosimilar, Novex, has yielded safety data validating the use of this agent in pediatric patients with a wide range of diseases and conditions, ranging from oncologic and hematologic to neurologic.

The agency plans to convene an advisory committee to review the application of Nuplazid to treat Alzheimer’s psychosis. The FDA also approved an indication for Opdivo, okays a third biosimilar to blockbuster cancer treatment Neupogen, and issues complete response letter for long-acting HIV therapy.

Getting boosted is now the rule, not the exception, when it comes to COVID-19 vaccination recommendations. The CDC now recommends that everyone, ages 12 and older, get a dose of an mRNA COVID-19 vaccine, either Pfizer’s or Moderna’s. For people who have gotten the two-shot Pfizer or Moderna series, the booster is their third jab. For those who got the single-dose Johnson & Johnson vaccine, it is the second.

The decades-long quest for a vaccine against HIV has been fruitless so far. Moderna hopes an HIV vaccine that uses its messenger RNA technology will break the losing streak. A phase 1 trial designed to include 56 volunteers has started.

Off-label Avastin, Eylea and Lucentis are the primary treatments for neovascular age-related macular degeneration (AMD), a leading cause of blindness. A recent review article looked at the impediments to the biosimilars for these drugs Ophthalmologists are wary about using biosimilars to Avastin (which was approved as a cancer drug) for AMD. Biosimilars to Eylea and Lucentis are not on the market yet. Manufacturers’ rebates and Medicare Part B “buy and bill” policies could make it difficult for them to compete against their brand-name “originator” products.

When managed care got started in the early ’80s, the focus was on physician and hospital services. Primary care doctors were positioned as gatekeepers, controlling referrals to specialists. Insurers came under a lot of criticism for shortening hospital stays. Now much of the managed care energy is trained on drug costs.