European Commission Approves Bavencio (Avelumab) for Metastatic Merkel Cell Carcinoma
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Category: Bio/Pharma/CRO
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
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
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
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
Roche provides update on first lampalizumab phase III study for geographic atrophy, an advanced form of age-related macular degeneration
Basel, 08 September 2017 Roche provides update on first lampalizumab phase III study for geographic atrophy, an advanced form of age-related macular degeneration Spectri study did not meet its primary endpoint of reducing mean change in geographic atrophy lesion area in patients treated with lampalizumab compared with sham treatment Safety profile was in line with... Read more
Roche presents data from global phase III study showing significant clinical benefit of Alecensa (alectinib) in later-line advanced ALK-positive lung cancer
Basel, 06 September 2017 Roche presents data from global phase III study showing significant clinical benefit of Alecensa (alectinib) in later-line advanced ALK-positive lung cancer ALUR study shows 85% reduction in risk of disease worsening or death versus chemotherapy in patients with advanced ALK-positive NSCLC who had progressed on chemotherapy and crizotinib Roche (SIX: RO,... Read more
SCIEX PA 800 Plus Continues to Deliver Quality Results for Ultimate Confidence in Biologics Characterization Data
SCIEX CE Trusted By Biopharma Laboratories and Manufacturers of Therapeutic Monoclonal Antibodies worldwide September 06, 2017 Framingham, MA — SCIEX, a global leader in life science analytical technologies, announced today that the SCIEX PA 800 Plus Pharmaceutical Analysis System is now used by virtually all manufacturers of commercial therapeutic monoclonal antibodies. The SCIEX PA 800 Plus runs various methods... Read more
Shimadzu's Updated LabSolutions Analytical Data SystemAdds Supplementary Data Integrity Functionsfor the Pharmaceutical Industry
Since the spring of 2016, the U.S. Food and Drug Administration (FDA), the British Medicines and Healthcare products Regulatory Agency (MHRA), and other regulatory agencies have strengthened the monitoring of quality assurance at pharmaceutical companies. Companies must now show that nothing improper has been done when using analytical instruments. In addition, in graphs showing data... Read more
BioLife Solutions Executes Supply Agreement with Celyad for CryoStor® Use in Natural Killer Receptor based T-Cell (NKR-T) Platform Targeting Solid Tumors and Blood Cancers
Proprietary Clinical Grade Cell Freeze Media Enables Long-Term Storage and Distribution of Engineered Cell-Based Therapies BOTHELL, Wash., July 31, 2017 /PRNewswire/ — BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife” or the “Company”), today announced that it has executed a long term supply agreement with... Read more