LONDON, England and DURBAN, South Africa, July 18, 2016 /PRNewswire/ --ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. Results show statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively. ARIA was a non-inferiority study with a pre-specified analysis for superiority. Both non-inferiority and superiority endpoints were met, with superiority being driven by lower rates of both virological failures and discontinuations due to adverse events (AEs) in the dolutegravir/abacavir/lamivudine group.
Genentech Provides Update on Phase III Study of Gazyva® in People With Previously Untreated Diffuse Large B-Cell Lymphoma
SOUTH SAN FRANCISCO, Calif.--(EON: Enhanced Online News)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III GOYA study evaluating Gazyva® (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint of significantly reducing the risk of disease worsening or death (progression-free survival; PFS) compared to Rituxan® (rituximab) plus CHOP chemotherapy (R-CHOP). Adverse events with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies. Data from the GOYA study will be presented at an upcoming medical meeting.
obidiag Secures 15 Million Euros from EIB to Accelerate the Launch of Its Novodiag® Platform and Suite of in Vitro Diagnostic Tests
PORI, Finland--(BUSINESS WIRE)--Mobidiag Oy, a Finnish molecular diagnostics company, today announced that it has signed a 15 million euro loan with the European Investment Bank Group. As part of the InnovFin initiative, the loan will allow Mobidiag to finalize and scale up Novodiag® products manufacturing, assay validation and commercialization over the next 3 years. The operation is supported by ‘InnovFin – EU Finance for Innovators’, with the financial backing of the European Union under Horizon 2020 Financial Instruments.
Dr. Reddy's Laboratories Announces the Launch of Omeprazole and Sodium bicarbonate Capsules in the U.S. Market
HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has launched Omeprazole and Sodium bicarbonate capsules, 20mg/1100mg and 40mg/1100mg, a therapeutic equivalent generic version of ZEGERID® (omeprazole/sodium bicarbonate) capsules in the United States market, having been approved by the U.S. Food & Drug Administration (USFDA).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its pharmaceutical sales subsidiary in Mexico, Eisai Laboratorios, S. de R.L. de C.V. (Location: Mexico City, “Eisai Mexico”) has received approval for the antiobesity agent VENESPRI(R) (lorcaserin hydrochloride, U.S. brand name: BELVIQ(R), “lorcaserin”) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes) by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), the Mexico regulatory authority. Mexico marks the first country in Latin America where lorcaserin is approved. Lorcaserin will be marketed in Mexico under the brand name VENESPRI.
ZUG, Switzerland--(BUSINESS WIRE)--The Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the European Medicines Agency (EMA). The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen (Nasdaq: BIIB). Earlier this year, the European Commission approved BENEPALI® (etanercept), a biosimilar referencing Enbrel®2, and FLIXABI® (infliximab), a biosimilar referencing Remicade®3.
Merck Receives European Medicines Agency Acceptance for Review of Marketing Authorization Application for Cladribine Tablets
Darmstadt, Germany, July 18, 2016 – Merck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the investigational product Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS).
Tagrisso demonstrated superior progression-free survival compared to standard platinum-based chemotherapy, with a safety profile consistent with previous trials First randomised trial to evaluate the clinical benefit of an EGFR T790M medicine, and data are consistent with those supporting Tagrisso approvals This announcement contains inside information AstraZeneca today announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomised trial assessed the efficacy and safety of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials. In addition to PFS, the objective response rate (ORR), disease control rate (DCR) and duration of response (DoR) also achieved clinically meaningful improvement versus chemotherapy. A full evaluation of AURA3 data, including an analysis of overall survival (OS), is ongoing, and results will be presented at an upcoming medical meeting.