Pharmaceutical Technology ePT Weekly
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PharmTech
September 5, 2019
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In this issue:

Valo Therapeutics Acquires Technology from Helsinki University

Gerresheimer Announces Pre-Fillable Syringe Product Line Expansion

EMA Recommends New Measures to Avoid Potentially Fatal Dosing Errors with Methotrexate


Top Stories

FDA Expands Scope of API Impurity Investigation

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
/ read more /


Drug Pricing and Politics

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.
/ read more /

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Industry News

EC Approves Tecentriq Combination Therapy for Metastatic Triple-Negative Breast Cancer

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.
/ read more /


New Trial Results Demonstrate Potential of Entresto in Reversing HFrEF damage

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.
/ read more /


More Industry News
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Supplier News

Valo Therapeutics Acquires Technology from Helsinki University

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.
/ read more /


Real-World Data Demonstrates Efficacy of OAC in Patients with NVAF

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.
/ read more /


More Supplier News
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Bio/Pharma News

Gerresheimer Announces Pre-Fillable Syringe Product Line Expansion

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.
/ read more /


Alvotech, Prestige Biopharma Form New
Manufacturing Partnership

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.
/ read more /


More Bio/Pharma News
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Regulatory News

EC Approves Tecentriq Combination Therapy for Metastatic Triple-Negative Breast Cancer

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.
/ read more /


 

EMA Recommends New Measures to Avoid
Potentially Fatal Dosing Errors with Methotrexate

EMA issued its recommendations surrounding the dosing of methotrexate in the treatment of inflammatory diseases, such as rheumatoid arthritis, psoriasis, and Crohn’s disease.
/ read more /


More Regulatory News

FEATURED TOPICS

PACKAGING

Smarter Packaging Comes to the Pharma Market

Active and intelligent packaging technologies benefit brand owners, caregivers, and patients.
/ read more /

MANUFACTURING

Gene Therapy Production Must Pass
Regulatory Hurdles

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.
/ read more /

SCALE UP

A Systematic Approach to Tech Transfer and 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.
/ read more /

FORMULATION

Rising to the Challenge of Biologic Drug Formulation

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
/ read more /


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
Tuesday, September 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Protecting Oxygen-Sensitive Formulations Throughout the Product Lifecycle
Tuesday, September 24, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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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"
Wednesday, September 11, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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ON DEMAND WEBCASTS

Method Development for Moisture Analysis in Lyophilized Products
On Demand
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Innovative Approaches to Tailoring Particle Size Distribution
On Demand
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Events

5th Annual Bio/Pharmaceutical Product Launch Summit

September 10–11, 2019

PDA/FDA Joint Regulatory Conference

September 16–18, 2019

PDA Data Integrity Workshop

September 18–20, 2019

more events

eBOOKS

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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