The World Health Organization (WHO) announced that the Burundi government launched an Ebola vaccine campaign for health and front-line staff working near the border with the Democratic Republic of Congo, which is experiencing an outbreak of the Zairian strain of the virus. Following WHO's recommendation, Burundi is using the experimental rVSV-ZEBOV vaccine, developed at Canada's National Microbiology Laboratory and then licensed to Newlink Genetics Corp., which in turn licensed it to Merck & Co. Inc. in a $500 million deal in 2014. Although further research is required before the vaccine can be licensed, it has been shown to be effective and safe during Ebola outbreaks in West Africa, according to WHO. Burundi is using the vaccine under a protocol that allows expanded access and compassionate use during Ebola outbreaks related to the Zaire strain. "No cases of Ebola have been reported in Burundi, but preparation remains crucial," WHO said. (See BioWorld, Nov. 25, 2014.)
As part of its proposed Physician Fee Schedule revisions for next year, the U.S. Centers for Medicare & Medicaid Services (CMS) plans to implement an expansion of the 2010 Physician Payment Sunshine Act, which was rolled into the Affordable Care Act. Passed last year as part of a sweeping bill addressing the opioid epidemic, the expansion requires drug companies to report payments made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives, as well as to doctors. The payment categories that have to be reported also would be expanded to include debt forgiveness, long-term loans of covered devices or medical supplies, and acquisitions of companies in which a covered recipient has an ownership interest. (See BioWorld, Aug. 1, 2013.)
The U.S. Court of Appeals for the Federal Circuit upheld a lower court's decision that claims 1 and 2 of Sanofi SA's '170 patent on prostate cancer drug Jevtana (cabazitaxel) would not have been obvious over docetaxel, which has been determined to be the lead compound and the closest prior art. However, the Federal Circuit said the trial court was wrong when it concluded that a case or controversy still existed with respect to cabazitaxel use claims in Sanofi's '592 patent. While Sanofi's infringement suit on both patents was pending against Fresenius Kabi USA LLC and other generic companies that had filed abbreviated new drug applications referencing Jevtana, the Patent Trial and Appeal Board (PTAB) instituted an inter partes review of the '592 patent. Soon after the district court trial began, PTAB determined that most of the claims in that patent were unpatentable as obvious and denied Sanofi's motion to amend them. While Sanofi appealed the board's denial of its motion to amend some of the claims, it filed a statutory disclaimer of the other claims. Saying that a case or controversy still existed, the district court went on to declare the disclaimed claims as invalid. In vacating that decision, the Federal Circuit said the lower court lacked the authority to do that. "Sanofi's disclaimer mooted any infringement-based dispute concerning those claims," the appeals court said.