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Top Stories
While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
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The multitude of health reform measures emerging on Capitol Hill has accelerated lobbying action across the board, along with campaign donations to candidates from all sides.
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Industry News
Roche revealed that the European Commission has approved the combination of Tecentriq (atezolizumab) with Abraxane for the treatment of adult patients with PD-L1-positive, metastatic triple-negative breast cancer.
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Novartis revealed results from two new clinical trials indicating that Entresto (sacubitril/valsartan) significantly improves measures of cardiac structure and function in heart failure with reduced ejection fraction.
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Supplier News
Valo Therapeutics has acquired a technology from Helsinki University that is expected to broaden its approach and expand the capability of its cancer vaccines platform, PeptiCRAd.
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Findings from a real-world data analysis have been released from the Bristol-Myers Squibb-Pfizer Alliance, demonstrating that Eliquis is associated with lower rate of major bleeding compared with vitamin K antagonist, dabigatran or rivaroxaban.
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Bio/Pharma News
Gerresheimer has announced it will be expanding its ClearJect product line of pre-fillable syringes with a new 2.25-mL cyclic olefin polymer (COP) staked in needle (SIN) syringe.
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Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.
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Regulatory News
Roche revealed that the European Commission has approved the combination of Tecentriq (atezolizumab) with Abraxane for the treatment of adult patients with PD-L1-positive, metastatic triple-negative breast cancer.
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EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
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PACKAGING
Active and intelligent packaging technologies benefit brand owners, caregivers, and patients.
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SCALE UP
Only careful planning can prevent problems that stem from differences between a sponsor's and a CDMO's equipment, practices, and culture. This article highlights best practices and case studies.
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FORMULATION
As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
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UPCOMING WEBCASTS
The Evolution of Cellulose in Tableting Technology
Wednesday, September 25, 2019 at 10am EDT | 3pm BST | 4pm CEST
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The Product Development Superhighway: Leveraging End-to-End Solutions for Market Success
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Protecting Oxygen-Sensitive Formulations Throughout the Product Lifecycle
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From Basics to Best Practices: Exploring Bioassays and Binding Assays
Thursday, September 19, 2019 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Considerations in Primary Packaging Component Selection for Parenteral Drug Delivery
Tuesday, September 17, 2019 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST
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Identifying and Solving Scale-up Challenges in the Synthesis and Formulation of Small-Molecule APIs
Thursday, September 12, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Implantable Systems and Microparticle Depots: Meeting the Formulation and Manufacturing Challenges of Long-Acting Drug Delivery"
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eBOOKS
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Biologics and Sterile Drug Manufacturing 2019
The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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