American Pharmaceutical News In Review

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November 20, 2020

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Webinar: Characterizing Biologics: Molecules and Methods

Join us on December 8 for a live webinar where we will introduce several biophysical methods like NMR, DSC, and MALS and explain you can evaluate and understand the best methods for your biologics. We will also discuss how orthogonal methods are leveraged to qualify and validate methods, providing early confidence.

	Industry News

CollPlant Announces Antiviral Agent Program for Potential Treatment of COVID-19 Patients
CollPlant announced its development program of an antiviral agent for potential treatment of COVID-... read more »

Tezepelumab Trial Meets Primary Endpoint
Amgen and AstraZeneca announced positive topline results from the Phase 3 trial in which the ... read more »

Supernus Provides Regulatory Updates for SPN-812 and SPN-830
Supernus announced updates for SPN-812 for ADHD and SPN-830 for motor fluctuations in Parkinson’s ... read more »

Arena Pharmaceuticals Reports Topline Results from Atopic Dermatitis Trial
Arena announced topline results from the Phase 2b ADVISE clinical trial evaluating etrasimod for ... read more »

FDA Approves Liquid Biopsy NGS Companion Diagnostic Test
The FDA approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test as... read more »

Ypsomed, SCHOTT Collaborate with Lonza to Develop Patch Injector Solution
Ypsomed is advancing its patch injector into a comprehensive solution by entering into a ... read more »

	QC Corner

The Role of Chemical Development and Drug Substance Manufacturing in Early Integrated CMC Development at Emerging and Virtual Pharma
Integrated chemistry, manufacturing and controls (CMC) development views the entire effort to ... read more »

Impact of Container Closure on Drug Safety
Pharmaceutical product container closure systems (CCS) should be designed to ensure that a drug ... read more »

	Featured Announcements

Developing Inhaled Generic Medicines – Navigating Complexity and Overcoming Challenges
Webinar
The development of inhaled generic medicines presents a number of unique challenges in terms of the product formulation, device design, drug-device combination, reference product performance and the regulatory environment. read more »

	Infographic

Total Organic Carbon (TOC) Monitoring Efficiency Quiz
Take our 10-question quiz with your team to find out if you have the most efficient TOC monitoring program. read more »

	Featured Articles

Remediation Consulting – The Wrong Prescription? As we sit at home on our computers attending meetings on Teams or Zoom, each of us is dealing with this crisis in our own way. Our world is being ... read more »

Integration of PAT and Data Systems for Manufacturing Process Control and Quality Improvement: A Brief Review of Past Developments, Current Status, and Certain Future Considerations Since the publication of the FDA’s PAT Guidance in September 2004, significant progress has been made in many aspects which boosted innovation in ... read more »

	Featured Video

On-Demand Roundtable: A Quality Perspective Roundtable Discussion on the Successes and Challenges of Making Changes to Pharma Workflow
In this roundtable you’ll learn about challenges faced by pharmaceutical quality teams in their material analysis workflows, and real-world solutions,... watch »

On-Demand Webinar: A Successful Journey to Cell Therapy Manufacturing: From R&D to Lot-Release
In this webinar you'll learn about regulatory requirements for GMP ancillary materials for cell and gene therapy, closed-system manufacturing and how ... watch »

	Featured Products

Gemini HPLC Columns
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µDISS Profiler Small Volume Dissolution and Solubility Apparatus
read more »

	Featured Whitepaper

Safe and Effective Aqueous Solutions for the Pharmaceutical Industry
The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation. Virtually any ... read more »

eBook: The Benefits of Employing FTIR, RAMAN and NIR Spectroscopy in Your Lab
Many of today’s plastics are multi component systems with multiple constituents like different polymers, fillers, plasticizers and compatibilizers. read more »

	Events

Sustainability In Bacterial Endotoxin Testing
Online – 12/10/2020
Horseshoe crabs in the United States are regulated and monitored carefully. event details »

CPhI North America
Philadelphia, PA – 04/20/2021
Over the last three years, CPhI North America has brought together more than 15,000 industry professionals across the entire pharmaceutical supply ... event details »

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