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Roche settles US patent lawsuit against Biogen over blockbuster arthritis drug

Swiss pharmaceutical company Roche has settled a patent lawsuit against U.S. biotech firm Biogen over its biosimilar version of Roche's blockbuster rheumatoid arthritis drug Actemra, according to a filing on Monday in Massachusetts federal court. Roche and its subsidiaries Genentech and Chugai Pharmaceutical jointly told the court without providing further details that they, Biogen and its manufacturer Bio-Thera had agreed to settle the case.
United States Blake Brittain David Bario Drug Administration Chugai Pharmaceutical Will Dunham
Source: aol.com

FDA Expands Entrectinib Indication in Pediatric Patients With NTRK+ Solid Tumors

The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.
Entrectinib Rozlytrek Ntrk Gene Fusion Pediatric Cancer

Baystreet.ca - The Fight Against Pancreatic Cancer Just Gained a New Ally with $200M VC Firm

VANCOUVER – USA News Group – A new cancer-focused venture capital firm is making headlines, having debuted with $200 million in funding from prominent individuals and institutions such as MIT, Memorial Sloan Kettering Cancer Center and The ...
United States British Columbia Matt Coffey Vinod Balachandran Julie Fleshman Steve Jobs

Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials a...
Glasgow City United Kingdom West Midlands United Kingdom General United States Daiichi Sankyo
Source: bmj.com

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Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorpora...
Glasgow City United Kingdom West Midlands United Kingdom General United States Daiichi Sankyo
Source: bmj.com

BioNTech Expands Late-Stage Clinical Oncology Portfolio with Initiation of further Phase 2 Trial with mRNA-based Individualized Neoantigen Specific Immunotherapy in New Cancer Indication

Initiation of Phase 2 builds on data from a Phase 1 clinical trial evaluating the safety and tolerability of autogene cevumeran in combination with the anti-PD-L1 immune checkpoint inhibitor...
United States Fosun Pharma American Society Of Clinical Oncology Exchange Commission Roche Group Asia Pacific

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