American Pharmaceutical News In Review

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July 08, 2020

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	Industry News

SARS-CoV-2 IgG Antibody Test Receives FDA Emergency Use Authorization
Beckman Coulter announced its Access SARS-CoV-2 IgG assay has received EUA from the FDA. read more »

Heron Receives CRL for HTX-011 for Postoperative Pain
Heron received CRL from the FDA regarding its NDA for HTX-011 for postoperative pain. read more »

RevImmune Announces Phase II Trial of the T-Cell Growth Factor for COVID-19
RevImmune has launched the "ILIAD" Phase II trial for treatment of COVID-19. read more »

RedHill Receives Approval for COVID-19 Phase 2/3 Study with Opaganib in UK
RedHill announced the UK MHRA has approved the Company’s CTA application to commence a study ... read more »

Croda Announces Acquisition of Avanti Polar Lipids
Croda International has agreed to acquire Avanti Polar Lipids, a company providing lipid-based drug ... read more »

Cosentyx Gains Positive CHMP Opinion for Pediatric Psoriasis
Novartis announced the CHMP of the EMA has adopted a positive opinion for Cosentyx for moderate-to-... read more »

	Featured Articles

Data Integrity: 2020 FDA Data Integrity Observations in Review In 2020 thus far, numerous warning letters have been issued from the FDA citing data integrity ... read more »

An Interview With... Dr. Piet Christiaens, Scientific Director, Nelson Labs Europe When assessing the impact of extractables or leachables from a safety perspective, there are two ... read more »

	Featured Announcements

MycoplasmaMatters – Answers to Your Real-World Mycoplasma Testing Questions
Webinar
Regulatory requirements, lot release, in-process testing, risk mitigation, live mycoplasma ... read more »

Advanced Features and Benefits of the Steritest™ NEO System
Advanced Features and Benefits of the Steritest™ NEO System
Sterility testing is one of the most crucial steps in pharmaceutical product release. read more »

	Featured Video

On-Demand Webinar: Validation Guidance for Residual Host Cell DNA Testing of Biologics
In this webinar, you'll learn the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) ... watch »

On-Demand Webinar: Making the Switch: The Evaluation, Implementation and Validation of Bringing Rapid Mycoplasma Testing In-House to Expedite Lot Release of Recombinant Protein Product
In this webinar, you'll learn about Octapharma’s evaluation of the PCR method, as an alternative to the traditional growth-based mycoplasma testing ... watch »

	Featured Products

Eshmuno® CMX Chromatography Resin
read more »

Sterility Test Isolator
read more »

	Featured Whitepaper

From LAL to rFC Assays: A more sustainable future for endotoxin testing
Bacterial endotoxins are pyrogenic lipopolysaccharides found in the outer cell membrane of Gram-negative bacteria. Ubiquitous in the environment, endotoxins can easily enter the patient’s bloodstream ... read more »

Tabletability: Compactibility and Compressibility: What’s the difference?
The science behind compressing a block of particles or granules into a single tablet can be complicated. But compression studies can tell you everything you need to know about compressing a ... read more »

	Events

CPhI North America
Philadelphia, PA – 04/20/2021
Over the last three years, CPhI North America has brought together more than 15,000 industry professionals across the entire pharmaceutical supply ... event details »

6th Annual QC Micro Summit
Francis Marion Hotel – 09/14/2020
It’s an event that’s aimed to let you step away from the bench, learn about the big trends impacting our industry, share great ideas, and develop new ... event details »

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