Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person

             Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We’re hopeful that reducing the burden of influenza may he lp to mitigate the strain on our healthcare system amid the COVID-19 pandemic.” Post-exposure prophylaxis with single-dose Xofluza was evaluated in the phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine.1 BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members 12 years of age an...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news

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Conclusions: A high serum CRP level on the initial day of TDM is an independent predictor of increasing vancomycin concentration-to-dose ratio in patients receiving intravenous vancomycin treatment, even if eGFR remains unchanged.
Source: Therapeutic Drug Monitoring - Category: Drugs & Pharmacology Tags: Original Article Source Type: research
This study evaluated the effects of the CYP2D6*10 and CYP2D6*5 genotypes on the steady-state plasma concentrations of VEN and ODV in Japanese patients. Methods: This study included 75 Japanese patients with depression who were treated with VEN. Steady-state plasma concentrations of VEN and ODV were measured using liquid chromatography. Polymerase chain reaction was used to determine CYP2D6 genotypes. A stepwise multiple regression analysis was performed to analyze the relationship between independent variables (sex, age, smoking habit, and number of mutated alleles, CYP2D6*10 and CYP2D6*5), subject-dependent variabl...
Source: Therapeutic Drug Monitoring - Category: Drugs & Pharmacology Tags: Original Article Source Type: research
Conclusions: After establishing an liquid chromatography with tandem mass spectrometry detection method for therapeutic drug monitoring of CAB, our analyses involving a single patient undergoing hemodialysis indicated that higher than expected doses of CAB were required to achieve reasonable plasma concentrations. Our study demonstrates the usefulness of therapeutic drug monitoring for the evaluation of “new” drugs in patients with renal impairment.
Source: Therapeutic Drug Monitoring - Category: Drugs & Pharmacology Tags: Short Communication Source Type: research
ConclusionsTrabectedin, in combination with PLD, may have clinical benefits in Japanese patients with relapsed advanced ovarian cancer. The recommended dosage of trabectedin for further study in this population is 1.1  mg/m2 once every 21  days.Clinical trial registration number: JapicCTI-163164
Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
This study aimed to evaluate the correlation between clinicopathologic features and serum zinc levels in patients who underwent gastrectomy for gastric cancer.MethodsThe study enrolled 617 patients who underwent gastrectomy for gastric cancer at the Kochi Medical School. Clinical data were obtained to investigate associations between clinicopathological features, including nutritional indicators and serum zinc levels. Serum zinc deficiency was defined as serum zinc level  
Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
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Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
AbstractBackgroundThe prognosis of patients with recurrence of uterine cervical cancer after definitive radiotherapy and the efficacy of local salvage therapy for recurrence were evaluated.MethodsWe retrospectively reviewed 110 patients who were treated with definitive radiotherapy/chemoradiotherapy for uterine cervical cancer between 2008 and 2017 at our institution. Local salvage therapy was defined as any surgery or radiotherapy described in the medical record as intended for local control or cure.ResultsWe identified 25 patients who developed recurrence after definitive radiotherapy/chemoradiotherapy. The median follow...
Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
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Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
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Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
ConclusionsThere was no difference in OS between irinotecan and paclitaxel no in OS prolongation of S-1 combination therapy in second-line chemotherapy.
Source: International Journal of Clinical Oncology - Category: Cancer & Oncology Source Type: research
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