American Pharmaceutical News In Review

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March 05, 2021

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Sign Up Now: Development Strategies for Expediting Time-to-Market of Spray Dried Amorphous Solid Dispersions

A roadmap of the spray drying development process will be presented, with all the main step to bring a new formulation to the market. A focus will be given to the importance of lab-scale familiarization and supporting studies through the development process and how computational, statistical tools combined with prior knowledge can be capitalized to reduce risk while maximizing time and resources.

	Industry News

Chimerix Announces Topline Results from Randomized COVID-19 Clinical Trial
Chimerix, worldwide licensee of Cantex's DSTAT investigational product, has reported promising ... read more »

U.S. Government to Purchase Etesevimab, Bamlanivimab Antibody Therapy
Junshi announced the U.S. government has agreed to purchase a minimum of 100,000 doses of etesevimab... read more »

ViaCyte, Gore to Develop Technologies that Enhance Delivery of Therapies for Diabetes
Two companies have signed an expanded joint development agreement covering the development and use ... read more »

SCYNEXIS Announces Positive Results of Oral Ibrexafungerp to Treat Severe Fungal Infections
SCYNEXIS announced positive results from the third interim efficacy analysis of the ongoing open-... read more »

FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A
The FDA approved Nulibry for injection to reduce the risk of death due to Molybdenum Cofactor ... read more »

Clearside Biomedical Completes Dosing in First Cohort Trial of CLS-AX for Wet AMD
Clearside Biomedical announced completion of dosing in the first cohort of OASIS, its ongoing Phase ... read more »

	QC Corner

Recent Advances to Help Cope with the Complexity of MS-Based Glycan Analysis
In a post-translational modification reaction called glycosylation, living organisms attach ... 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 Articles

Process Steps from Cell-Line Preparation to Manufacture of Personalized Medicines Compliance with Good Manufacturing Practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorization. Likewise... read more »

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 U.S. Patent Office in September-... read more »

	Featured Video

On-Demand Webinar: Solid Form Analysis – In-depth Understanding of API’s Behavior
In this webinar you’ll learn how to evaluate stability of a formulation early in the drug product development process, what impact can distribution of... watch »

On-Demand Webinar: Sustainability In Bacterial Endotoxin Testing – A Holistic Approach to Conservation and Recombinant Technology
In this webinar you’ll learn about the current conservation/sustainability status of the horseshoe crab population in the US, new developments in ... watch »

	Featured Products

VITEK MS MALDI-TOF Mass Spectrometer for Microorganism Identification
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Crodasol HS HP
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	Featured Whitepaper

White Paper: Validation Guidance for Residual Host Cell DNA Testing of Biologics
Assurance of product safety and quality are top of mind for all biotherapeutic manufacturers read more »

ebook: Lipid Excipients to Unlock Oral Bioavailability Issues
Oral dosage forms favor good patient acceptance and compliance in great part because they are easy to take. However, achieving sufficient bioavailability by the oral route can be challenging due to ... read more »

	Events

Scalable In-line Concentration Measurement for Biologic Process Development and GMP Manufacturing
Online – 03/16/2021
Process analytical technology (PAT) has been widely adopted in the biopharmaceutical industry. event details »

Commercializing Continuous Processing in Pharma 2021
Virtual – 03/23/2021
The 5th Commercializing Continuous Processing in Pharma 2021 will reunite the growing CCP community to discuss how to accelerate adoption of ... event details »

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