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

CHMP recommends EU approval for Roche’s TECENTRIQ (atezolizumab) in a specific type of metastatic lung and two types of metastatic bladder cancer

Basel, 21 July 2017 CHMP recommends EU approval for Roche’s TECENTRIQ (atezolizumab) in a specific type of metastatic lung and two types of metastatic bladder cancer TECENTRIQ as a potential treatment option for people with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) TECENTRIQ as a potential treatment option for people with... Read more

Canopy Biosciences Enters Bioprocessing Market with Launch of Host Cell Protein Detection Kits

Canopy Biosciences signs deal with Array Bridge to market kits for impurity analysis ST. LOUIS, July 13, 2017 /PRNewswire/ — Canopy BiosciencesTM, LLC, an emerging provider of gene editing and personalized medicine technologies, announced today that it will enter the bioprocessing field by marketing kits for host cell protein detection. Array Bridge, a biotech company that developed the... Read more

Sanofi to acquire Protein Sciences

– Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio – Jul 11, 2017 Paris, France – July 11, 2017 – Sanofi announced today it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States. Under the terms of the agreement, Sanofi will make an upfront payment of $650 million... Read more

Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine

Basel, 10 July 2017 Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine HAVEN 1 showed emicizumab reduced bleed rate by 87% compared with on-demand bypassing agents All 12 secondary endpoints in HAVEN 1 were positive, including an intra-patient comparison that showed emicizumab reduced bleed rate... Read more