January 25, 2021 Bio/Pharma/CRO

Roche’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration

Faricimab given at intervals of up to every 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks, potentially reducing the frequency of injections and overall burden of treatment Nearly half of people were treated with faricimab every 16 weeks during the first year – the first time this level of... Read more

January 19, 2021 Bio/Pharma/CRO Clinical Research/Diagn. Lab Top-10

Thermo Fisher Scientific to Acquire Point-of-Care Molecular Diagnostics Provider Mesa Biotech

Thermo Fisher Scientific to Acquire Point-of-Care Molecular Diagnostics Provider Mesa Biotech WALTHAM, Mass., Jan. 19, 2021 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it has entered into a definitive agreement to acquire Mesa Biotech, Inc., a privately held molecular diagnostic company, for approximately $450 million in cash.... Read more

December 21, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness

Faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks in both studies More than half of participants in the faricimab personalised dosing arms had extended time between treatments to 16 weeks at year one – the first... Read more

December 10, 2020 Bio/Pharma/CRO Clinical Research/Diagn.

Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020

People with muscle-invasive urothelial cancer (MIUC) who had detectable circulating tumour DNA (ctDNA) were more likely to benefit from treatment with adjuvant (after surgery) Tecentriq monotherapy, compared with those without ctDNA The goal of current treatment in people with MIUC is to provide early intervention to reduce the risk of the disease recurring or spreading... Read more

December 10, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

GE Healthcare Completes Portfolio of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) with U.S. FDA Approval of Clariscan in 5mL Glass Vials

The U.S. FDA has approved 5mL glass vial packaging for Clariscan (gadoterate meglumine), completing its packaging portfolio. Clariscan is now approved for patients aged two years and under, making the 5mL vials an efficient option for helping to minimize potential contrast wastage with pediatric patients. Clariscan has been approved in more than 70 countries globally,... Read more

December 7, 2020 Bio/Pharma/CRO PAI Top-10 Product Launch

New follow-up phase III data reinforce the long-term benefit of Roche’s Hemlibra for people with haemophilia A

Basel, 7 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra® (emicizumab).[1] These data, from adults, adolescents and children with haemophilia... Read more

December 2, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

Roche announces FDA approval of Gavreto (pralsetinib) for people with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancers

Basel, 2 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy,... Read more

November 24, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

GE Healthcare Announces U.S. FDA approval of macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) in Pre-Filled Syringes

U.S. FDA approves pre-filled syringe packaging for the macrocyclic gadolinium-based contrast agent, Clariscan™ (gadoterate meglumine). Clariscan has been approved in more than 70 countries globally, with more than seven million patient doses shipped, and now offers a wider range of packaging http://www.ge.com/news/press-releases/ge-healthcare-announces-us-fda-approval-of-macrocyclic-mri-contrast-agent Read more

November 24, 2020 Acad, Gov/Utilities Bio/Pharma/CRO

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

Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis) Roche also provides an update on the sNDA filing for Xofluza in the paediatric setting              Basel, 24 November 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food... Read more

November 23, 2020 Bio/Pharma/CRO Product Launch

Agilent Launches New NanoDis System for Nanoparticle Dissolution Testing

System addresses the pharmaceutical industry’s need for compliant, semi-automated testing of nanoparticle drug formulations SANTA CLARA, Calif., November 23, 2020  Agilent Technologies Inc. (NYSE: A) today announced the introduction of the NanoDis System for nanoparticle dissolution testing. Combining Agilent instrumentation and software to enable customers to meet 21 CFR Part 11 and other regulations through its... Read more