American Pharmaceutical News In Review

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June 17, 2019

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Infographic - Microbial Testing: Five Myths Vs. Reality

When it comes to microbial testing for pharmaceutical products, it can be difficult to sort through the various guidelines to determine which are necessary and which are not. Many common questions are answered in this informative "myths vs reality" infographic.

	Industry News

Ampio Announces FDA Regulatory and Clinical Update
Ampio announced it received FDA approval of the Company's special protocol assessment (SPA) of a ... read more »

Blueprint Medicines Submits NDA for Avapritinib
Blueprint Medicines has submitted a NDA to the FDA for avapritinib for the treatment of adult ... read more »

Reistone Announces First Patient Dosed in Two Phase II Studies of SHR0302
Reistone Biopharma announced dosing of the first patient in their Phase II global clinical trials of... read more »

CD20xCD3 Bispecific REGN1979 Shows Positive Results for R/R B-cell Non-Hodgkin Lymphoma
Regeneron announced positive early-stage data for REGN1979 in patients with relapsed or refractory (... read more »

Sun Pharma Announces Data Showing Potential of ILUMYA™ to Improve Psoriatic Arthritis Symptoms
Sun Pharmaceutical announced interim results from a Phase 2 study of interleukin-23 (IL-23) ... read more »

FDA Approves KANJINTI
The FDA has approved KANJINTI™ for all approved indications of the reference product, Herceptin® for... read more »

	Featured Articles

Low-Frequency Raman Mapping and Multivariate Image Analysis for Complex Drug Products Confocal Raman mapping provides a robust means of characterization that can non-destructively ... read more »

Raw Materials and Functional Excipients Roundtable The contribution of functional excipients has greatly increased over the last decade. The key ... read more »

	Featured Video

On-Demand Webinar: Using Single-Use Technology to Enable Single- Pass TFF
In this webinar, you'll learn what Single-Pass TFF is and how it works, Single-Pass Tangential Flow Filtration (SPTFF), and versatility in ... read more »

Watch Video: Interview with Frederic Kahn from Hovione
Watch Video: Hovione Interview with Frederic Kahn read more »

	Featured Products

Diffucaps Customized Release Technology
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Soluplus
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	Featured Whitepaper

HPLC-DAD Analysis of Nucleotides Using a Fully Inert Flowpath
Phosphorylated compounds such as nucleotides are known to interact with stainless steel components leading to recovery issues in HPLC and LC/MS. read more »

Detection of Pyrogens Pyromat 2019008029
A pyrogen is, by definition, a substance that produces a rise in temperature in a human or animal. read more »

	Events

CPhI China
Shanghai, China – 06/18/2019
CPhI & P-MEC China 2019 is your gateway to successfully growing your business at the 2nd largest pharma market in the world. Whether you are looking ... event details »

Clinical Operations in Oncology Trials East Coast 2019
Cambridge, MA – 07/10/2019
The Clinical Operations in Oncology Trials (CTO) meeting returned to Boston for its 6th year with over 150 attendees from biopharmaceutical, medical ... event details »

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