American Pharmaceutical News In Review

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February 19, 2021

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Lonza expands solid state services to meet accelerated timelines for increasingly complex molecules

Lonza’s Solid Form Services expands with a dedicated team working to select, characterize, and develop lead forms and polymorphs, supporting both drug substance and drug product development.

	Industry News

RedHill Biopharma Announces First Patient Dosed in COVID-19 Outpatient Study
RedHill Biopharma announced the first patient was dosed in its U.S. study of orally-administered RHB... read more »

FDA Grants Sotorasib Priority Review Designation for Advanced, Metastatic NSCLC
Amgen announced the FDA has granted Priority Review for sotorasib for KRAS G12C-mutated locally ... read more »

PTC Therapeutics Initiates Second Stage of FITE19 Trial Evaluating PTC299 for COVID-19
PTC Therapeutics announced the initiation of the second stage of the FITE19 clinical trial to assess... read more »

Verrica Announces FDA Filing Acceptance for VP-102 for Molluscum Contagiosum
Verrica announced its resubmitted NDA for VP-102, a proprietary topical therapy for the treatment of... read more »

Astellas Expands Top Management
Astellas announced the expansion of its top management to include two new positions. read more »

Logan Announces New Transdermal Diffusion Cell Drive Consoles
Logan has announced a new addition to their transdermal diffusion cell testers family – the Logan “E... read more »

	QC Corner

Comparative Assessment of Spray Drying and Hot Melt Extrusion as Amorphous Solid Dispersion Manufacturing Processes
Part I provided an overview of the historical perspective of the genesis and application of spray ... read more »

QC Corner: The Intersection of Development and Manufacturing
QC Corner: The Intersection of Development and Manufacturing read more »

	Featured Articles

Still Moving Forwards: Recent Advances with Rapid Microbiological Methods Rapid microbiological methods continue to advance, with novel technologies appearing on the marketplace albeit more orientated towards general ... read more »

IDMP – Transforming Medicine Management with Global Data Standards The coronavirus response highlighted the need for global data standards in medicine, giving renewed impetus to work on IDMP (Identification of ... read more »

	Featured Video

Watch Video: G-Con Manufacturing, Inc. Facility Tour
Since 2009, G-CON has lead the cleanroom industry, fulfilling pharmaceutical and biopharmaceutical needs and embracing new trends. G-CON designs, ... watch »

On-Demand Webinar: Platform Purification Approaches for the Production of Complex Biologics
In this webinar we will discuss the attributes of Thermo Scientific POROS Ion Exchange and Hydrophobic Interaction chromatography resins, addressing ... watch »

	Featured Products

Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
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Gemini HPLC Columns
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	Featured Whitepaper

eBook: Lipid Technologies: Helping to Develop the Next Generation of Pharmaceuticals
The FDA recently issued guidance intended to curtail the use of medically important antibiotics in agricultural applications. read more »

Safe and Effective Aqueous Solutions for the Pharmaceutical Industry
The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation. Virtually any ... 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 »

Reactive-to-Proactive Process Monitoring in Pharmaceutical Waters
Online – 03/17/2021
In pharmaceutical water process monitoring, there is a need to change operating philosophy from reactive to proactive. event details »

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