American Pharmaceutical News In Review

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June 09, 2021

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Challenges and Best Practices for Extractables and Leachables in Ophthalmic Drug Products

Prior to 2018, ophthalmic drug products (ODPs) and parenteral drug products (PDPs) were both treated the same way when undergoing Extractables and Leachables (E&L) testing. However, ODPs differ significantly from PDPs in terms of route of administration, toxicological end-points and the nature of their container closure system.

	Industry News

FDA Approves Novartis Cosentyx for Children with Plaque Psoriasis
Novartis, a leader in immuno-dermatology and rheumatology, announced that the U.S.FDA has approved ... read more »

MorphoSys to Acquire Constellation Pharmaceuticals
MorphoSys and Constellation Pharmaceuticals announced that they have entered into a definitive ... read more »

EC Approval for Opdivo Plus Yervoy as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) ... read more »

	Featured Announcements

Webinar: Troubleshooting Drug Production with Vibrational Spectroscopy
Register
Are you considering developing a new drug? Join us on June 30th, 2021 at 10 a.m. PT, 1 p.m. ET for our How Vibrational Spectroscopy Helps to Accelerate New Drug Development and to Troubleshoot Drug Production webinar, sponsored by Bruker. In this ... read more »

	Infographic

Reasons to Upgrade to Windows® 10 for Your Lab
With the end of support for Windows® 7 more than a year ago, it's definitely time to upgrade to Window® 10. Many labs are still running various ... read more »

	Featured Articles

Exosomes - The Good, Bad, Ugly and Current State Exosomes are small membrane sacs or vesicles produced by cells. From a pharmaceutical scientist view, exosomes are endogenous lipid nanoparticles (... read more »

Characterization of DNA Impurities in Cell Therapies T cells play important roles in adaptive immunity by serving as sentinels against foreign pathogens. T cells that have been engineered to recognize ... read more »

	Featured Video

On-Demand Webinar: Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices
This webinar will address how to deal with “Risk Assessment for Potential Elemental Impurities” on Drug Products and Medical Devices. The USP, in ... watch »

On-Demand Webinar: A Novel At-Line Pharmaceutical-Grade Mycoplasma Testing Solution: Sample to Results in Less than One-Hour
In this webinar you’ll learn about how this “lab in a pouch” technology works, primary validation data, and biopharmaceutical company evaluation data. watch »

	Featured Whitepaper

ebook: Aseptic Processing Trends and Technologies
eBook offers a variety of strategies to optimize you aseptic fill finish small batch manufacturing to take advantage of the growing market for small-batch biopharmaceuticals. read more »

	Events

SMi’s 4th Annual Conference Pharmaceutical Microbiology West Coast
Virtual – 06/17/2021
SPONSORED BY: Associates of Cape Cod, bioMérieux, Bioscience International, Microcoat, Millipore Sigma and Mettler Toledo Co-chairs Jim Polarine, ... event details »

Virtual DCAT Week 2021
Online – 07/12/2021
DCAT Week is the premier business event for the Bio/Pharmaceutical development and manufacturing industry. The DCAT Board of Directors has decided to ... event details »

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