American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

February 19, 2020

Newsletter Sponsor

Video: How do you know your cleaning process is effective?

TOC analysis should be deployed in cleaning validation applications to assess the overall effectiveness of a cleaning process, rather than solely looking at a single API. Techniques such as HPLC may not identify degradants, detergents, or other excipients that can affect purity or safety of a drug product. Learn how to obtain reliable TOC measurements and confidently release equipment back into production.

	Industry News

FDA Approves Three Drugs for Nonprescription Use
The FDA approved three drugs for nonprescription, or OTC, use through a process called a ... read more »

Regulus Therapeutics Reinitiates RGLS4326 Study for ADPKD Treatment
Regulus has initiated dosing of the second cohort of its Phase 1 multiple ascending dose clinical ... read more »

Brickell Biotech Announces Settlement with Bodor Labs
Brickell Biotech and its subsidiary announced the company and Bodor Laboratories and Dr. Nicholas S.... read more »

LumiThera to Expand Research into Diabetic Retinopathy for Valeda® Light Delivery System
LumiThera has initiated further studies with the University of Wisconsin-Milwaukee to establish the ... read more »

MediciNova Receives Notice of Allowance for MN-001, MN-002 Patent for NASH Treatment
MediciNova has received a Notice of Allowance from the Japan Patent Office for a pending application... read more »

EyePoint, Vision Center Network of America Sign Purchase Agreement for DEXYCU
EyePoint and VCNA have entered into a purchase agreement for DEXYCU 9% for its surgery centers ... read more »

	Featured Articles

Novel Small Molecule Drug Discovery Platform Harnesses Immune System to Defeat Cancers, Viral Infections and Inflammatory Diseases More than 300 million patients worldwide are infected with hepatitis B virus (HBV). Each year, more ... read more »

Studying Phase Transitions in Pharmaceuticals Many pharmaceutical materials are developed in solid form for practical reasons, such as storage ... read more »

	Featured Announcements

In Vitro Test Methodologies for Characterizing Bioavailability Enhancing Formulations
Webinar
A large and increasing fraction of orally administered small molecules in pharma company pipelines ... read more »

	Featured Video

On-Demand Webinar: TOC and Conductivity Analysis: Back to Basics
In this webinar, you'll learn about regulations for USP <643> Total Organic Carbon, USP <645> Conductivity and regulatory expectations for cleaning validation, ... read more »

On-Demand Webinar: Burkholderia cepacia Contamination of Pharmaceutical Products: A problem that does not go away
In this webinar, you'll learn about the recent USP chapter, <60>, guidance for Bcc isolation, selective media, growth promotion, and suitability studies.... read more »

	Featured Products

Pegasus 4D GCxGC-TOFMS
read more »

VITEK MS MALDI-TOF Mass Spectrometer for Microorganism Identification
read more »

	Featured Whitepaper

eBook: Implementing Microbial Analysis Technologies for World-Class Production
This eBook covers microbial testing, analysis, and monitoring technologies and strategies to ensure world-class pharmaceutical production. Article cover topics such as data integrity issues, ... read more »

Performance of Single-use Virus Filtration at Biopharmaceutical Manufacturing Scale
Commercial manufacturing of biologics such as monoclonal antibodies (mAbs) and recombinant proteins requires robust, reliable processes which cost-efficiently deliver high yields of a safe and ... read more »

	Events

IFPAC® - 2020
North Bethesda, MD – 02/23/2020
Process Analytical Technology is one of the most exciting and important advanced technology areas meeting both the current challenges, as well as the ... event details »

BIO Digital
Digital – 06/08/2020
For 2020, the BIO International Convention will transition to a new, virtual event format, BIO Digital. This virtual gathering of the global biotech ... event details »

This information is being brought to you because you are a subscriber to
American Pharmaceutical Review. To ensure delivery to your inbox,
please add newsletters@americanpharmaceuticalreview.com to your address book.

Manage your Subscription | Unsubscribe | Contact American Pharmaceutical Review

American Pharmaceutical Review
395 Oyster Point Blvd, Suite 300
South San Francisco, CA 94080 USA