American Pharmaceutical News In Review

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December 14, 2021

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	Industry News

Nuvation Bio Announces FDA Clearance of Investigational NDA for NUV-422 for the Treatment of Advanced Breast Cancer
Nuvation Bio Inc. announced that the FDA has cleared its investigational new drug (IND) application ... read more »

Saol Therapeutics Announces FDA Approval of LYVISPAH™ (baclofen) Oral Granules and the Divesture of its Plasma-derived Hyperimmune Portfolio
LYVISPAH™ (lye-vis'-pah) is indicated for the treatment of spasticity resulting from multiple ... read more »

Pfizer and BioNTech Provide Update on Omicron Variant
Pfizer Inc. and BioNTech SE announced results from an initial laboratory study demonstrating that ... read more »

Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potenc
Teligent Pharma, Inc. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, ... read more »

	Infographic

5 Reasons to Switch to Multi-Column Chromatography
5 Reasons to Switch to Multi-Column Chromatography
Multi-column chromatography (MCC) technologies can transform existing batch processes and provide many advantages such as up to 80% reduction in ... read more »

	Featured Articles

Pharmaceutical P.I.N. Points Patent Innovation News The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in June-July ... read more »

Clarifying and Meeting the Requirements of 21 CFR Part 11 and Data Integrity for Dissolution Testing Since the release of the latest FDA guidance documents on 21 CFR part 11 and data integrity, there has been much confusion regarding what is required ... read more »

	Featured Video

On-Demand Webinar: The Modern Microbiologist’s No-Nonsense Guide to Quality Control
In this webinar, you’ll learn the essentials of Growth Promotion Testing, why Environmental Monitoring should be a part of your QC program, and a year... watch »

On-Demand Webinar: Microbial Identification in a Manufacturing Environment
In this webinar we will discuss how recent technological developments allow for rapid micro testing and rapid micro identification, focusing on the ... watch »

	Featured Products

Versynta Small Batch Machine Portfolio
read more »

	Featured Whitepaper

White Paper: Implementation of the Slope Spectroscopy Method
Protein concentration is an important part of monoclonal antibody production. Traditionally, a UV-Visible spectroscopy method is used to measure protein concentration in this setting, but it has some ... read more »

	Events

DCAT Sharp Sourcing
Online – 01/26/2022
This 90-minute webinar brings together a panel of industry experts to offer valuable and practical insights into what companies need to consider and ... event details »

Microscopy & Microanalysis 2022
Portland, OR – 07/31/2022
Portland provides an ideal summer backdrop for what promises to be another stellar M&M meeting! The Pacific Northwest region is a vacationer's dream, ... event details »

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