To air challenging issues related to patient and market access to new anticancer agents, the Biotherapy Development Association—an international group focused on developing targeted cancer therapies ...using biological agents—convened a meeting on 29 November 2007 in Brussels, Belgium. The meeting provided a forum for representatives of pharmaceutical companies and academia to interact with European regulatory and postregulatory agencies. The goal was to increase all parties' understanding of their counterparts' roles in the development, licensure, and appraisal of new agents for cancer treatment, events guided by an understanding that cancer patients should have rapid and equitable access to life-prolonging treatments. Among the outcomes of the meeting were a greater understanding of the barriers facing drug developers in an evolving postregulatory world, clarity about what regulatory and postregulatory bodies expect to see in dossiers of new anticancer agents as they contemplate licensure and reimbursement, and several sets of recommendations to optimize patients' access to innovative, safe, effective, and fairly priced cancer treatments.
The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear.
We randomly assigned 16,492 patients ...with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke.
A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval CI, 0.89 to 1.12; P=0.99 for superiority; P<0.001 for noninferiority); the results were similar in the "on-treatment" analysis (hazard ratio, 1.03; 95% CI, 0.91 to 1.17). The major secondary end point of a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group (12.8% and 12.4%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio, 1.02; 95% CI, 0.94 to 1.11; P=0.66). More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure (3.5% vs. 2.8%; hazard ratio, 1.27; 95% CI, 1.07 to 1.51; P=0.007). Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups (acute pancreatitis, 0.3% in the saxagliptin group and 0.2% in the placebo group; chronic pancreatitis, <0.1% and 0.1% in the two groups, respectively).
DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events, though the rate of hospitalization for heart failure was increased. Although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes. (Funded by AstraZeneca and Bristol-Myers Squibb; SAVOR-TIMI 53 ClinicalTrials.gov number, NCT01107886.).
We search for lepton-flavor-violating τ^{-}→e^{-}α and τ^{-}→μ^{-}α decays, where α is an invisible spin-0 boson. The search uses electron-positron collisions at 10.58 GeV center-of-mass energy with ...an integrated luminosity of 62.8 fb^{-1}, produced by the SuperKEKB collider and collected with the Belle II detector. We search for an excess in the lepton-energy spectrum of the known τ^{-}→e^{-}νover ¯_{e}ν_{τ} and τ^{-}→μ^{-}νover ¯_{μ}ν_{τ} decays. We report 95% confidence-level upper limits on the branching-fraction ratio B(τ^{-}→e^{-}α)/B(τ^{-}→e^{-}νover ¯_{e}ν_{τ}) in the range (1.1-9.7)×10^{-3} and on B(τ^{-}→μ^{-}α)/B(τ^{-}→μ^{-}νover ¯_{μ}ν_{τ}) in the range (0.7-12.2)×10^{-3} for α masses between 0 and 1.6 GeV/c^{2}. These results provide the most stringent bounds on invisible boson production from τ decays.
The Belle II experiment at the Super B factory SuperKEKB, an asymmetric e+e− collider located in Tsukuba, Japan, is tailored to perform precision B physics measurements. The centre of mass energy of ...the collisions is equal to the rest mass of the ϒ(4S) resonance of mϒ(4S) = 10.58 GeV. A high vertex resolution is essential for measuring the decay vertices of B mesons. Typical momenta of the decay products are ranging from a few tens of MeV to a few GeV and multiple scattering has a significant impact on the vertex resolution. The VerteX Detector (VXD) for Belle II is therefore designed to have as little material as possible inside the acceptance region. Especially the innermost two layers, populated by the PiXel Detector (PXD), have to be ultra-thin. The PXD is based on DEpleted P-channel Field Effect Transistors (DEPFETs) with a thickness of only 75 μm. Spatial resolution and hit efficiency of production detector modules were studied in beam tests performed at the DESY test beam facility. The spatial resolution was investigated as a function of the incidence angle and improvements due to charge sharing are demonstrated. The measured module performance is compatible with the requirements for Belle II.
The L_{μ}-L_{τ} extension of the standard model predicts the existence of a lepton-flavor-universality-violating Z^{'} boson that couples only to the heavier lepton families. We search for such a ...Z^{'} through its invisible decay in the process e^{+}e^{-}→μ^{+}μ^{-}Z^{'}. We use a sample of electron-positron collisions at a center-of-mass energy of 10.58 GeV collected by the Belle II experiment in 2019-2020, corresponding to an integrated luminosity of 79.7 fb^{-1}. We find no excess over the expected standard-model background. We set 90%-confidence-level upper limits on the cross section for this process as well as on the coupling of the model, which ranges from 3×10^{-3} at low Z^{'} masses to 1 at Z^{'} masses of 8 GeV/c^{2}.
The Belle II Physics Book Kou, E; Bishara, F; Brod, J ...
Progress of theoretical and experimental physics,
02/2020, Letnik:
2020, Številka:
2
Journal Article
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The Belle II Theory Interface Platform (B2TiP) was created as a physics prospects working group of the Belle II collaboration in June 2014. It offered a platform where theorists and experimentalists ...could work together to elucidate the potential impacts of the Belle II program, which includes a wide scope of physics topics: B physics, charm, τ, quarkonium physics, electroweak precision measurements, and dark sector searches.
We present the first measurement of the ratio of branching fractions of inclusive semileptonic $B$-meson decays, $R(X_{e/\mu}) = \mathcal{B}(B\to X \, e \, \nu) / \mathcal{B}(B\to X \, \mu \, \nu)$, ...a precision test of electron-muon universality, using data corresponding to $189\,\mathrm{fb}^{-1}$ from electron-positron collisions collected with the Belle II detector. In events where the partner $B$ meson is fully reconstructed, we use fits to the lepton momentum spectra above $1.3\,\mathrm{GeV}/c$ to obtain $R(X_{e/\mu}) = 1.007 \pm 0.009~(\mathrm{stat}) \pm 0.019~(\mathrm{syst})$, which is the most precise lepton-universality test of its kind and agrees with the standard-model expectation.
We report the first search for a nonstandard-model resonance decaying into τ pairs in e^{+}e^{-}→μ^{+}μ^{-}τ^{+}τ^{-} events in the 3.6-10 GeV/c^{2} mass range. We use a 62.8 fb^{-1} sample of ...e^{+}e^{-} collisions collected at a center-of-mass energy of 10.58 GeV by the Belle II experiment at the SuperKEKB collider. The analysis probes three different models predicting a spin-1 particle coupling only to the heavier lepton families, a Higgs-like spin-0 particle that couples preferentially to charged leptons (leptophilic scalar), and an axionlike particle, respectively. We observe no evidence for a signal and set exclusion limits at 90% confidence level on the product of cross section and branching fraction into τ pairs, ranging from 0.7 to 24 fb, and on the couplings of these processes. We obtain world-leading constraints on the couplings for the leptophilic scalar model for masses above 6.5 GeV/c^{2} and for the axionlike particle model over the entire mass range.
BACKGROUND Small cell lung cancer (SCLC) represents about 20% of primary lung tumours and the costs associated with the management of SCLC can be significant. The main objective of this study was to ...obtain information on current patterns of care and associated resource use and costs for patients with SCLC from initial diagnosis and treatment phase, throughout disease progression and terminal care. METHODS A 4 year retrospective patient chart analysis (1994–7) was conducted on a consecutive series of 109 patients diagnosed with SCLC in two Newcastle hospitals. For this consecutive series of patients all details about care received including tests and procedures, treatment, and medication from diagnosis till death were recorded. Pathways of care and forms were designed to enable resource use to be captured for different disease phases. Unit costs were determined from a variety of sources including the Newcastle Hospitals NHS Trust Finance Department and the British National Formulary. RESULTS The average total cost per patient calculated for the full cohort of 109 patients was £11556. Initial treatment was the most resource use intensive constituting 48.2% of the total cost. The major cost element throughout all disease phases was hospitalisation. Twenty eight percent of the total costs of care occur after recurrence of the disease until death, of which 73% are generated by terminal care. CONCLUSION The results of this retrospective medical chart analysis show that the costs of care of SCLC are considerable, although the variability between patients in terms of the type and quantity of resource use is very high. Analyses such as this provide a useful insight into resources used in actual clinical practice.
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