September 27, 2017 Bio/Pharma/CRO Chromatography Lab Top-10 Product Launch

Shimadzu’s New Nexera FV Ultra High Performance Liquid Chromatograph Dramatically Reduces the Time Spent Conducting Dissolution Tests for the Development and Quality Control of Pharmaceuticals

Evaluation of the dissolution of drug products is important in the development and quality control of pharmaceuticals. Especially for generic pharmaceuticals, a dissolution test must be performed to validate their bioequivalence and whether it has been changed by the content and dosage form. Ultraviolet spectrophotometers are mainly used to measure the dissolution amount. However, a... Read more

September 27, 2017 Bio/Pharma/CRO Clinical Research/Diagn.

First patient enrolled into phase I clinical trial of Oncolytic Virus HF10 against pancreatic cancer in Japan

First patient enrolled into phase I clinical trial of Oncolytic Virus HF10 against pancreatic cancer in Japan Kusatsu/Shiga, Japan — September 27, 2017 — Takara Bio Inc. (Takara Bio), today announced that the first patient with pancreatic cancer has been enrolled into Oncolytic Virus HF10(TBI-1401) phase I clinical trial in Japan on September　26, 2017. This... Read more

September 22, 2017 Acad, Gov/Utilities Bio/Pharma/CRO Chromatography Clinical Research/Diagn. Lab Top-10 PR/Corporate

Agilent Technologies Receives Expanded FDA Approval for the Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Gastric or Gastroesophageal Junction (GEJ) Cancer

Patients with gastric or GEJ adenocarcinoma whose tumors express PD-L1 can now be identified for potential treatment with KEYTRUDA® (pembrolizumab) using PD-L1 IHC 22C3 pharmDx SANTA CLARA, Calif., September 22, 2017 Agilent Technologies Inc. (NYSE: A) today announced its Dako PD-L1 IHC 22C3 pharmDx assay has an expanded label approved by U.S. Food and Drug... Read more

September 22, 2017 Bio/Pharma/CRO Licensing, IP, and Legal

Roche receives EU approval of TECENTRIQ® (atezolizumab) in a specific type of metastatic lung cancer and two types of metastatic bladder cancer

Basel, 22 September 2017 Roche receives EU approval of TECENTRIQ® (atezolizumab) in a specific type of metastatic lung cancer and two types of metastatic bladder cancer TECENTRIQ provides a new treatment option for people with previously treated locally advanced or metastatic non-small cell cancer (NSCLC) TECENTRIQ is a new treatment option for people with metastatic... Read more

September 22, 2017 Bio/Pharma/CRO Licensing, IP, and Legal

Roche receives EU approval of Gazyvaro for people with previously untreated advanced follicular lymphoma

Basel, 22 September 2017 Roche receives EU approval of Gazyvaro for people with previously untreated advanced follicular lymphoma Approval is based on phase III GALLIUM study results, which showed superior progression-free survival for Gazyva/Gazyvaro compared to MabThera/Rituxan Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Gazyvaro® (obinutuzumab) in combination... Read more

September 18, 2017 Bio/Pharma/CRO PR/Corporate

Phase III data showed that Venclexta/Venclyxto plus MabThera/Rituxan helped people with previously treated chronic lymphocytic leukaemia live longer without their disease worsening compared to bendamustine plus MabThera/Rituxan

Basel, 18 September 2017 Phase III data showed that Venclexta/Venclyxto plus MabThera/Rituxan helped people with previously treated chronic lymphocytic leukaemia live longer without their disease worsening compared to bendamustine plus MabThera/Rituxan Data from pivotal phase III study will be submitted to health authorities and presented at an upcoming medical meeting Roche (SIX: RO, ROG; OTCQX:... Read more

September 18, 2017 Bio/Pharma/CRO PR/Corporate

Phase III data showed that Venclexta/Venclyxto plus MabThera/Rituxan helped people with previously treated chronic lymphocytic leukaemia live longer without their disease worsening compared to bendamustine plus MabThera/Rituxan

Basel, 18 September 2017 Phase III data showed that Venclexta/Venclyxto plus MabThera/Rituxan helped people with previously treated chronic lymphocytic leukaemia live longer without their disease worsening compared to bendamustine plus MabThera/Rituxan Data from pivotal phase III study will be submitted to health authorities and presented at an upcoming medical meeting Roche (SIX: RO, ROG; OTCQX:... Read more

September 13, 2017 Acad, Gov/Utilities Bio/Pharma/CRO Lab Top-10

Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay

Assay Detects Genetic Anomalies and Helps Move Inquiries from Cause to Care Faster SANTA CLARA, Calif., September 13, 2017 Agilent Technologies Inc. (NYSE: A) has announced that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the GenetiSure Dx Postnatal Assay: its first comparative genomic hybridization (CGH) assay for diagnostic... Read more

September 11, 2017 Bio/Pharma/CRO

Roche announces phase III study results of Zelboraf for adjuvant treatment of BRAF V600 mutation-positive melanoma

Basel, 11 September 2017 Roche announces phase III study results of Zelboraf for adjuvant treatment of BRAF V600 mutation-positive melanoma Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf® (vemurafenib) in the adjuvant (after surgery) treatment of people... Read more