When it comes to patent term extensions, a requested continued examination doesn't end until the U.S. Patent and Trademark Office (PTO) mails the notice of allowance, the U.S. Court of Appeals for the Federal Circuit said in a precedential ruling handed down Monday in Mayo Foundation for Medical Education and Research v. Iancu. Otherwise, "an unduly burdensome, fact-intensive inquiry" would be needed to determine when the PTO actually conceded the allowability of the claims, the appeals court said. On another issue, the court ruled that a continued examination isn't limited to the issues the applicant wants to see resolved. "Continued examination, both on its own terms and as interpreted by the PTO . . . simply entitles an applicant to continue examination. It is not just an opportunity to seek rehearing of a final rejection, and, as in regular examination, the PTO's regulations allow the examiner to issue a new ground of rejection," the court said.
Nitrosamine impurities are no longer just a concern with angiotensin II receptor blockers (ARBs) used to treat blood pressure. The EMA and FDA are investigating how low levels of N-nitrosodimethylamine (NDMA), a potential carcinogen, got into prescription and over-the-counter ranitidine drugs. The regulators are evaluating whether the NDMA levels in the anti-acid drugs pose a risk to patients. At this point, neither agency has pursued recalls of drugs such as Zantac (ranitidine, Sanofi SA), as they did with the ARBs containing NDMA-contaminated sartans. Meanwhile, the EMA is developing guidance for avoiding nitrosamine impurities in human drugs containing chemically synthesized active substances, and it's considering whether guidance is needed for other types of drugs. "It is of paramount importance that we learn from our experience with sartans and take a proactive approach for other classes of medicines," EMA Executive Director Guido Rasi said.
The FDA approved new warnings for the labeling of Ibrance (palbociclib, Pfizer Inc.), Kisqali (ribociclib, Novartis AG) and Verzenio (abemaciclib, Eli Lilly and Co.), advising that the CDK 4/6 inhibitors may cause rare but severe inflammation of the lungs when they're used to treat some patients with advanced breast cancers. Despite the new warning, the agency said the overall benefit of the drugs is still greater than the risks when used as prescribed, as the drugs have been shown to improve progression-free survival in adults with HR-positive, HER2-negative advanced or metastatic breast cancer that has spread to other parts of the body. The FDA is encouraging patients to notify their doctor right away if they have new or worsening symptoms involving their lungs, including shortness of breath and difficulty or discomfort with breathing.
The Institute for Clinical and Economic Review (ICER) found that additive treatments like Xarelto (rivaroxaban, Janssen Pharmaceuticals Inc.) and Vascepa (icosapent ethyl, Amarin Corp.) can provide additional benefits for patients at high risk of cardiovascular disease. Furthermore, the prices reflect those benefits, falling below the cost-effectiveness threshold, according to ICER's evidence report that assessed the comparative clinical effectiveness and value of the two drugs. ICER will review the report at the Sept. 26 public meeting of its Midwest Comparative Effectiveness Public Advisory Council.
Although the rebates drug companies paid to Medicare Part D plan sponsors substantially reduced the growth of total Part D spending from 2011 to 2015, the Health and Human Services Office of Inspector General (OIG) found the rebates didn't prevent increased overall Part D spending for brand drugs. Medicare still spent $2 billion more for brand drugs with rebates in 2015 than in 2011, the OIG said in a report requested by Congress.
The FDA is releasing 32 new draft and 15 revised draft product-specific guidances to help sponsors of generics develop bioequivalence studies, according to a notice to be published in Tuesday's Federal Register. Comments on the guidances are due by Nov. 16.