American Pharmaceutical News In Review

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February 10, 2021

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Computational Methods and High Throughput Screening in the Formulation of ASDs

Join us February 24th as we discuss Amorphous Solid Dispersions (ASD) with staff from Hovione. ASD manufacturing has become an established and commercially demonstrated strategy to improve the bioavailability of poorly water-soluble drugs. However, the perceived complexity in the development of an ASD formulation has been cited as an obstacle to the use of this strategy in favor of simpler, albeit less enabling solutions.

	Industry News

Apotex Recalls Enoxaparin Sodium Injection
Apotex is voluntarily recalling two batches of Enoxaparin Sodium Injection due to a packaging error. read more »

Imfinzi Trial Does Not Meet Primary Endpoint
The KESTREL trial for AstraZeneca’s Imfinzi did not meet the primary endpoint of improving OS versus... read more »

Supernus Resubmits NDA for SPN-812 for ADHD in Pediatric Patients
Supernus has resubmitted its NDA for SPN-812 for the treatment of ADHD in pediatric patients. read more »

Hackensack Meridian Health Awarded $5.5 Million by DOD to Continue COVID-19 Plasma Work
Researchers at Hackensack Meridian Health have been awarded Department of Defense funds to continue ... read more »

FDA Approves TEPMETKO for Metastatic Non-Small Cell Lung Cancer
The FDA approved TEPMETKO for metastatic NSCLC harboring MET exon 14 skipping alterations. read more »

Surface Ophthalmics Announces First Patient Dosed in SURF-200 Trial for Acute Dry Eye
Surface Ophthalmics announced the first patient has been dosed in the trial for SURF-200 for acute ... read more »

	QC Corner

QC Corner: Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of mAbs and ADCs
Product characterization is the essential foundation for successful biological drug development. read more »

The Effect of Surge Vessels on the Residence Time Distribution of Drug Substance Continuous Processes
While most of the published work on the impact of residence time distribution (RTD) to ... read more »

	Featured Articles

Three Ways to Simplify Endotoxin Testing The race to develop and manufacture COVID-19 vaccines and treatments has put a spotlight on Bacterial Endotoxins Testing (BET) and the criticality of... 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 US Patent Office from August-... read more »

	Featured Video

On-Demand Webinar: Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection
In this webinar you’ll learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling ... watch »

On-Demand Webinar: Revolutionary approach to UV-Vis measurements using the SoloVPE® Slope Spectroscopy
In this webinar, we will review VPT and how it can be used in various applications from protein therapeutics to gene therapy. We will share real-world... watch »

	Featured Products

FTPA2000-260PH Multi-point FT-NIR Analyzer
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Diffucaps Customized Release Technology
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	Featured Whitepaper

eBook: Slope Spectroscopy Method
The SoloVPE System is an innovative instrument for the UV-VIS-NIR spectroscopy. read more »

White Paper: Optimizing the Bio-Rad NGC Chromatography System for Cryo-EM Applications for High-Resolution and Low-Volume SEC
Structural biology is the three-dimensional study of complex biological molecules, like proteins, to determine their structures at atomic resolution. read more »

	Events

IFPAC - 2021
Virtual – 02/28/2021
IFPAC - 2021 will be held February 28 - March 5, 2021 LIVE, REAL-TIME event. The goal of IFPAC remains to support, connect, and unite our Community. ... event details »

Parallel Trade 2021
Virtual – 03/22/2021
SMi present’s its 15th annual Parallel Trade virtual conference, taking place virtually on the 22nd and the 23rd March 2021. As the only parallel ... event details »

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