Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

Flavour spectrum of the Puff family of disposable e-cigarettes

BackgroundIn January 2020, the US Food and Drug Administration prohibited the sale of flavours (except for menthol and tobacco) in prefilled pod devices such as JUUL to decrease youth vaping. Excluded from the prohibition were disposable devices.ObjectivesTo determine the scope and scale of flavours marketed by Puff Bar, a leading disposable brand, and related products.MethodsDisposable e-cigarette flavours were identified via online searches encompassing vendor websites, wholesale distributors, manufacturers (eg, made-in-china.com), and social media channel, Instagram, between June and August 2020.ResultsThe ‘Puff’ brand name and iconic cloud logo appear on a variety of products of differing sizes and nicotine e-liquid volumes. Among Puff Bar and its copycats (Puff-a-Likes), 139 flavours were identified. Fruit flavours predominated comprising 82.2% of the flavour varieties (fruit 50%, fruit and menthol/mint 23.6%, and fruity drinks 8.6%). A prevalent new flavour category which combines fruit with menthol/mint (Ice) was offered in 33 varieties such as Lychee Ice, Lush Ice and Banana Ice. Disposable e-cigarette brands are undertaking measures to escape tobacco regulation (eg, non-tobacco-sourced nicotine) and flavour limitations via post-market flavour additions to unflavoured nicotine e-liquid.ConclusionsThe proliferation of flavoured disposable e-cigarette products, many of which are designed to emulate popular pod devices, illustrates that narrowly limited flavour regulations covering only a single category are destined to fail. To be effective in youth protection, flavour regulations need to apply to all recreational nicotine-containing products and need to include measures to counter post-market flavour addition.

Forensic Linguistics function in Evidentiary and Investigative Contexts

the main aim of this paper is to provide insights into the vital role of FL in Evidentiary and Investigative Contexts. the paper contains many segments; Authorship analysis and attribution, Plagiarism Detection, Speaker identification, and voice comparison, Language as evidence in civil cases (Trademark, Brand name Law, Defamation).

Clinical and laboratory testing of oral anticoagulation therapy vitamin k antagonists at the emergency department of Hanoi Heart Hospital

Background: The most commonly used oral anticoagulant is acenocoumarol with the brand name is Sintrom and recently, warfarin with the brand name is Coumadin has begun to be used. Anticoagulation with vitamin K antagonists faces two main obstacles: the narrow therapeutic range and the effectiveness of the drug varies by many factors. Objective: " Current status of coagulation disorders in the treatment of anticoagulants with vitamin K antagonists. Understanding some factors affecting the goal of anticoagulant treatment". Method: Cross-sectional, retrospective, descriptive analysis of drug use and influencing factors of patients diagnosed with coagulopathy admitted to the emergency department at Hanoi Heart Hospital from April 2020 to August 2021. Results: There were 675 patients admitted to the hospital with blood clotting disorders. The average age is 60,17±10,13, the youngest is 30, the oldest is 90; 63 patients, accounting for 9.42%, need to be hospitalized for inpatient treatment; There are 108 patients, accounting for 16%, with bleeding and 18 patients, accounting for 2.7%, with thromboembolism or valve obstruction. Conclusion: Coagulation disorders during treatment with vitamin K antagonist anticoagulants is a common condition in the emergency department. However, the complication rate is not high. There are many factors that affect the patient's treatment goals and the drug use is a fairly common factor.

International scientific publications of Thu Dau Mot University through statistics from 2015 to 2020

International scientific publication is one of the activities that help improve the quality of scientific research and develop the brand name of the university. This paper presents some key features of Thu Dau Mot University’s international scientific publications through statistics from 2015 to 2020 based on the following criteria: the number of publications in international journals (included ISI, Scopus and non-ISI, Scopus), field of science, gender and research collaboration. In addition, this paper will discuss some initial identifications: (1) the number of international scientific publications has grown rapidly and steadily over the years; (2) the number of international scientific publications is concentrated in the natural science, engineering and technology; (3) social science and education’s contribution in international scientific publications has been limited;(4) there is a significant difference in the number of international scientific publications between male and female scholars; (5) Research collaboration has an important role in the international scientific publications of Thu Dau Mot University.

Accentuating cardiovascular events in Sibutramine-treated patients

Sibutramine has been used as an anti-obesity drug, sold under the brand name of Meridia, among others. However, it was banned in various countries after a statistically impactful finding that it increases the risk of cardiovascular events even in patients who were not at a predisposed risk. Despite these findings, Sibutramine is still prescribed in Pakistan, in spite of the high prevalence of cardiovascular diseases in our population. In this letter, we have summarized the long-known, and recent findings regarding Sibutramine and have also provided the statistics to empower our reasoning. We believe that this letter will prove to be a valuable asset in spreading awareness regarding Sibutramine within the medical community in Pakistan. Continuous...

Touring activities of Ukrderzhtsirk as a domain’s “health” indicator

The purpose of the article is to identify and analyze the effectiveness of the Ukrainian state circus arts system’s touring activities from the early 1990s. Methodology. The study analyses archival information on the Ukrderzhtsirk’s work. The historical-factographic method helps to record the results of the circus touring activities development. Comparative analysis allows detecting the specifics of the phenomenon, revealing its organizational and creative trends, and evaluating them. Scientific novelty. For the first time, the main trends of the Ukrainian state circus touring activities held since the early 1990s were revealed and characterized. Conclusions. The touring activities’ effectiveness is characterized by declining trends – something that corresponds to the general dynamics of the “post-Soiuzgostsirk” organizational and creative process. Probably one of the decline factors was that of the head organization’s inability to provide the circus system with a properly centralized management. Ukrderzhtsirk has some achievements, in particular, its own brand-name founding, business contacts establishing, organizing of abroad tours for Ukrainian programs. However, the state circus product’s export faces its decline, while the sector of import is not prospective as a foreign product is too expensive. Obviously the current organizational and creative approaches to foreign economic activities performing are in need to be revised. Keywords: Ukrainian circus arts, Soviet circus, touring, Ukrderzhtsirk, Soiuzgostsirk, circus arts enterprise, circus arts product.

Future Sales Estimation using Patents

We propose a model to improve estimation accuracy of the future sales volume, focusing on pharmaceutical products, from their patents. Our approach is based on an analysis of patents obtained in the early development stages of the products. The development of pharmaceuticals often takes a long time (up to several decades in some cases), and the costs are huge, even exceeding one billion USD for just one product. Therefore, it is strongly desirable to estimate future sales volume at an early stage. One piece of information potentially useful for the estimation is the brand, i.e., the name of the developing company. Our model learns the sales volume and words used in multiple patent specifications and also focuses on the extent to which “seasonal” words are used. Experiments showed that our model much improved the accurately of the sales volume estimation compared with the case of just estimating from its brand name.

Efficacy, Safety, Cost, and Clinical Outcomes After the Switch to Generic Rosuvastatin Compared with Consistent Brand-Name Atorvastatin Treatment.

Background: The efficacy, safety, and clinical outcomes for patients switch to generic rosuvastatin, compared with patients taking other brand-name atorvastatin, is unclear. Method: We retrospectively collected electronic medical records from January 1, 2013, to December 31, 2020, of patients who switched medication, because of hospital policy, from brand-name to generic rosuvastatin after March 14, 2018. we only considered patients who had taken the medication at least 1 year prior to and 1 year after that date. We also collected records of patients who consistently used brand-name atorvastatin during the same period. The efficacy of lipid control, potential adverse effects, clinical outcomes of major cardiovascular events (MACE), and medical expenses were compared between the 2 groups. Propensity score matching (PSM) was conducted to balance potential cofounders. Result: After 1:1 PSM, 592 patients were enrolled in the rosuvastatin and atorvastatin groups, and no significant difference was observed in their total cholesterol (TC) level difference (−4.38 ± 23.0 vs. −3.72 ± 26.95 mg/dL, P = 0.702), low-density lipoprotein (LDL-C) (−2.38 ± 19.89 vs. −2.42 ± 23.63 mg/dL, P = 0.976), or glycated hemoglobin (−0.05% ± 0.7% vs. −0.08% ± 0.76%, P = 0.543). No significant differences were noted in their cumulative MACE (2.70% vs. 3.89%, log-rank P = 0.265) after the switch date, and each person in the generic group had a 16% average reduction in their medical expenses. Conclusion: Switching to generic rosuvastatin led to comparable lipid-lowering efficacy, safety, and clinical outcomes and fewer medical expenses compared with consistently using brand-name atorvastatin.