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Objective: In the double-blind, phase III, placebo-controlled RUBY randomized clinical trial, dostarlimab plus carboplatin-paclitaxel significantly increased survival among patients with primary advanced or recurrent endometrial cancer (EC). We conducted a cost-effectiveness analysis of dostarlimab in combination with chemotherapy in these patients stratified by mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) subgroups from the perspective of a United States payer. Materials and methods: A Markov model with three states was employed to simulate patients who were administered either dostarlimab in combination with chemotherapy or chemotherapy based on the RUBY trial. Quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER) were calculated with a willingness-to-pay (WTP) threshold of $150,000 per QALY. Both univariate and probabilistic sensitivity analyses were carried out to explore the robustness of the model. Results: In dMMR EC, the combination of dostarlimab and chemotherapy achieved an additional 5.48 QALYs at an incremental cost of $330,747 compared to chemotherapy alone, resulting in an ICER of $60,349.30 per QALY. In pMMR EC, there were 1.51 additional QALYs gained at an extra cost of $265,148, yielding an ICER of $175,788.47 per QALY. With a 15.2% discount on dostarlimab, the ICER decreased to $150,000 per QALY in the pMMR EC. The univariate sensitivity analysis revealed that the cost of dostarlimab, utility of progression-free survival (PFS), and progressive disease (PD) had the most significant impacts on the outcomes. Probabilistic sensitivity analysis revealed that dostarlimab had a 100% likelihood of being considered cost-effective for patients at a WTP threshold of $150,000 per QALY for dMMR EC, whereas this likelihood was only 0.5% for pMMR EC. Conclusion: Dostarlimab in combination with chemotherapy was cost-effective for primary advanced or recurrent dMMR EC from the perspective of a United States payer at a WTP threshold of $150,000 per QALY, but not for pMMR EC. Lowering the prices of dostarlimab could potentially enhance the cost-effectiveness of treatment for pMMR EC. [ABSTRACT FROM AUTHOR]

Mechanisms on regulatory coherence or good regulatory practices have emerged as one of the unique features of preferential trade agreements (PTAs) in the age of mega-regionalism. Led by the United States, for instance, the Trans-Pacific Partnership (‘TPP’), now known as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (‘CPTPP’) introduces a standalone chapter that focuses on the domestic rule-making process. Such design is unique for it goes beyond traditional output-oriented proxies by including a set of input-oriented elements that apply to the rulemaking process of each party, before a regulatory action is taken. These elements, like transparency, public consultation, regulatory impact assessment, inter-agency coordination and review, are in large part modelled on the American Administrative Procedure Act (‘APA’) and several executive orders with a view to ‘rationalising’ the administrative lawmaking process and to responding to the concerns about a regulatory state. For years, the US has been exporting this APA-style regulatory philosophy elsewhere: from the Organisation of Economic Co-operation and Development (‘OECD’) and the Asia-Pacific Economic Cooperation (‘APEC’) to trade negotiations to which it is a party, including the above-mentioned TPP and the Transatlantic Trade and Investment Partnership (‘TTIP’). Notwithstanding these efforts, however, there are hurdles for regulatory coherence to be further diffused as a new global norm since it goes beyond trade to involve complicated economic, social and political endowments of different trading partners. The role of another two major players, namely China and the European Union, is hence of particular significance in this context. This article seeks to sketch out the contour of the emerging regulatory coherence by mapping the trajectory of its historical development and offering a comprehensive survey of how China, European Union, and the United States have managed it across different contexts. [ABSTRACT FROM AUTHOR]

Among other provisions of the Trans-Pacific Partnership (TPP) Agreement, a new clause on encryption technology ('Encryption Clause') is particularly noteworthy. By tracing the history of decades-long encryption control, this article underscores how this clause implicates international order. Modern encryption technology was conceived and developed during World Wars. Painted by such a war-time legacy, encryption has been treated as a 'dual-use' technology and has been subject to export control since the end of World War II via the Coordinating Committee for the Control of Multinational Trade (COCOM) and, later, the Wassenaar Arrangement. With the collapse of the Soviet Union, the Western bloc became divided on encryption policies. The US was most concerned with national security and once attempted to introduce the mandatory key escrow scheme to provide a level playing field for its high-tech industry. Resistance to the US's hard line approach towards encryption at home and abroad led the nation to relax its export controls, thereby ending Crypto War 1.0. With the rise of emerging economies, however, Crypto War 2.0 is now resurfacing, and through the Encryption Clause, the US seeks to remove trade barriers that are hostile towards products employing foreign cryptography. Yet, underlying intellectual property right (IPR)(issues and the role of intelligence units in the formation of technical standards may once again move trade negotiations into the shadows. [ABSTRACT FROM AUTHOR]

Background: Acute pharyngitis accounts for an estimated 15 million patient visits in the United States. However, there is no proven effective and safe treatment. Although Chinese herbal medicine is widely used in the treatment of acute pharyngitis, there is a lack of evidence-based data. Despite several clinical trials conducted in this setting, no randomized placebo-controlled trial has been performed to date. This trial aims to investigate the efficacy and safety of Qi-Wei-Qing-Yan aerosol (QWQYA), a Chinese herbal prescription, compared with a placebo aerosol in the treatment of acute pharyngitis with lung-stomach excess-heat syndrome.Methods/design: This is a prospective, multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial. A total of 420 adult patients, of either sex, with acute pharyngitis will be enrolled from seven study sites across China. All patients will be randomly allocated to one of three parallel treatment groups: (1) QWQYA with the current propellant, (2) QWQYA with a previous propellant, and (3) the placebo aerosol with the current propellant. The study medication will be administered into the pharyngeal region in three sprays thrice daily for 5 consecutive days. The primary outcome measures are time to complete resolution of sore throat and relief rate of sore throat. Secondary outcome measures include resolution rate of sore throat, time to relief of sore throat, intensity of sore throat, and change of traditional Chinese medicine syndrome score and clinical signs score from baseline to post-treatment, as well as the occurrence of any adverse events.Discussion: This will be the first clinical trial to investigate the efficacy and safety of QWQYA in the treatment of acute pharyngitis in an adult population in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it establish the basis for the efficacy and safety of QWQYA in treating acute pharyngitis, but it might also provide evidence to support the use of Chinese herbal medicine in treating acute pharyngitis and thus support an alternative treatment option for management of acute pharyngitis.Trial Registration: Chinese Clinical Trial Registry ChiCTR-IPR-15005991. [ABSTRACT FROM AUTHOR]

The article discusses the court case, K-V Pharmaceutical Company v. U.S. Food and Drug Administration, from the U.S. District Court for the District of Columbia, which deals with compounding rules under the federal Food, Drug and Cosmetic Act (FDCA). The Court reviewed allegations by the pharmaceutical firm that the agency had adopted a policy to not enforce provisions of the FDCA against compounding pharmacies. The Court ruled in favor of the agency.

The manipulation of the US dollar and other countries' currencies has been a longstanding American prerogative, thus American politicians and scholars are accustomed to labeling countries that fight against American policies on the US dollar as "currency manipulators." The substance of America's accusation of currency manipulation against China is that when America starts to control dollars in order to transfer its domestic economic problems abroad, China is expected to do nothing and simply live with an unstable RMB exchange rate. Obviously, there is a great difference between China and Japan. China will never allow itself to become "the second Japan" that swallows bitter pills like the Plaza Accord. [ABSTRACT FROM AUTHOR]

The article presents a study which compares the prevalence of potentially inappropriate medication (PIM) use among older adults in the U.S. between 1996 and 2007. The study employs the 2007 Medical Expenditure Panel Survey (MEPS), while the subjects were the community-dwelling adults who are 65 years or older. It reveals the decline on the number of of community-dwelling older adults who received at least one of the 33 PIMs, from 6.9 million in 1996 to 5.4 million in 2007.

The 2009 swine-origin Influenza A virus subtype H1N1 (S-OIV) is generally believed to be a mixture of human, bird and swine viruses, resulting from multiple reassortments. The evolutionary origin of the S-OIV is of high interest but still remains obscure. In order to understand the evolution of the new virus, we performed sequence homology, segment stability and segment linkage analysis, as well as analysis of the host and geographic distribution of the evolutionarily related viruses. Stability analysis demonstrated that segment 6 (NA) was the most unstable one, followed by segment 4 (HA), while the other 6 segments were relatively stable. Host and geographic distribution analysis indicated that all 8 segments of the new virus were closely related to those of swine influenza viruses circulating either in North America or in Eurasia. Segment linkage analysis showed that segments 1 (PB2), 2 (PB1), 3 (PA), 4 (HA), 5 (NP), and 8 (NS) are in linkage disequilibrium exclusively with North American swine influenza viruses, and segments 6 (NA) and 7 (M) are evolutionarily linked solely with Eurasian swine influenza viruses. Two North American swine strains and 2 Eurasian swine strains were identified as possible ancestors of S-OIV 2009. Based on the most recent linkage analysis with the updated influenza sequences, South Dakota avian strains were found to be the closest known relatives of S-OIV 2009. [ABSTRACT FROM AUTHOR]

The authors report the results of a study investigating the efficacy of the cultural adaptation of a voluntary counseling and testing (VCT) program aimed at increasing the use of condoms and decreasing rates of sexually transmitted diseases (STDs). Study participants were a group of female sex workers (FSWs) in Guangxi, China. The intervention was modeled after a U.S. Centers for Disease Control and Prevention Project called RESPECT. FSWs were either assigned to received the VCT intervention or to a control group that received STD testing and treatment. Outcome measures were knowledge and perceptions about HIV/STDs, condom use and history of STDs. The VCT intervention group scored higher in HIV/STD knowledge and consistent condom use and had a substantially lower infection rate.

Prostate-specific promoters are frequently employed in gene-mediated molecular imaging and therapeutic vectors to diagnose and treat castration-resistant prostate cancer (CRPC) that emerges from hormone ablation therapy. Many of the conventional prostate-specific promoters rely on the androgen axis to drive gene expression. However, considering the cancer heterogeneity and varying androgen receptor status, we herein evaluated the utility of prostate-specific enhancing sequence (PSES), an androgen-independent promoter in CRPC. The PSES is a fused enhancer derived from the prostate-specific antigen (PSA) and prostate-specific membrane antigen gene regulatory region. We augmented the activity of PSES by the two-step transcriptional amplification (TSTA) system to drive the expression of imaging reporter genes for either bioluminescent or positron emission tomography (PET) imaging. The engineered PSES--TSTA system exhibits greatly elevated transcriptional activity, androgen independency, and strong prostate specificity, verified in cell culture and preclinical animal experimentations. These advantageous features of PSES--TSTA elicit superior gene expression capability for CRPC in comparison with the androgen-dependent PSA promoter--driven system. In preclinical settings, we showed robust PET imaging capacity of PSES--TSTA in a castrated prostate xenograft model. Moreover, intravenous administrated PSES--TSTA bioluminescent vector correctly identified tibial bone marrow metastases in 9 of 9 animals, whereas NaF- and FDG-PET was unable to detect the lesions. Taken together, this study showed the promising utility of a potent, androgen-independent, and prostate cancer--specific expression system in directing gene-based molecular imaging in CRPC, even in the context of androgen deprivation therapy. [ABSTRACT FROM AUTHOR]

In light of the "false or misleading" standard resulting from the recent legal ruling, it can be concluded that a true claim is one that is both factually and analytically true. Factual truth could be based on the accuracy of the information and the sufficiency of the information. Analytical truth could be based on the scientific foundation for the claim and whether the information within the claim is presented in a balanced way. Regarding the assessment of whether a truthful claim is misleading, the evaluator could consider the relevance, consistency, and context of the information. Standards are important in medication use and medication regulation. Health care professionals who must decide whether a claim is truthful and not misleading will rely on guidance from FDA in determining how to evaluate promotional claims. As the court suggested in the case reviewed here, FDA could take the lead and provide guidance "in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information." Existing FDA regulations provide a foundation for such guidance. The next step for the agency would be to expand existing guidance to specifically describe how an off-label claim can be identified as either false or misleading.