American Pharmaceutical News In Review

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August 05, 2019

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New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis

Over-the-counter (OTC) medication is used by almost every individual from teething infants to our oldest citizens. The high utilization rate of these medications makes managing the quality of OTC products a crucial part of the pharmaceutical manufacturing process.

	Industry News

Agilent Companion Diagnostic Gains Expanded FDA Approval
Agilent announced the FDA has approved the company’s PD-L1 IHC 22C3 pharmDx assay for expanded use. read more »

FDA Issues Draft Guidance Regarding Clinical Trial Design for Newborns
The FDA has issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ... read more »

Verzenio Demonstrates Significant Improvement in Overall Survival in Breast Cancer Trial
Eli Lilly and Company announced Verzenio (abemaciclib) demonstrated a statistically significant ... read more »

NIIMBL, FDA Sign New Agreement to Support Biopharmaceutical Manufacturing
The NIIMBL announced that the University of Delaware, on behalf of NIIMBL, has entered into a CRADA ... read more »

Biohaven Enrolls First Patient in Verdiperstat Phase 3 Clinical Trial
Biohaven announced it has enrolled the first patient in a Phase 3 clinical trial to evaluate the ... read more »

Sangamo Announces Executive VP, General Counsel Appointment
Sangamo Therapeutics announced the appointment of Gary H. Loeb as Executive Vice President and ... read more »

	Featured Articles

Insider Insight: How Pharma Can Embrace Transparency and Turn Pricing Reform into an Advantage Recent regulations designed to alter drug manufacturers’ relationships with PBMs may be just the tip... read more »

An Interview with Catalent One of the major technical challenges is the delivery of poorlysoluble drugs. read more »

	Featured Video

Watch Video: Sievers Complete Pharma Solution
Watch Video: Sievers Complete Pharma Solution read more »

B&W Tek- Celebrating 20 Years of Excellence!
B&W Tek is excited to celebrate 20 years of providing innovative solutions to a variety of different industries worldwide, including the ... read more »

	Featured Products

HyClone CCM5 Cell Culture Media
read more »

Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
read more »

	Featured Whitepaper

cGMP Radiosynthesis for Early Phase Clinical Trials: A Unique Challenge and Development of a Standard Process
Radiolabeled drugs are used in human ADME and bioavailability studies. read more »

Preventing Sticking and Picking Through Tablet Design
Sticking and picking are two common problems encountered in tablet manufacturing. read more »

	Events

CPhI Korea
South Korea – 08/21/2019
CPhI Korea provides a dynamic meeting place for a wide range of industry suppliers to engage with purchasers and decision makers from the ... event details »

5th Annual QC Micro Summit
Charleston, SC – 09/24/2019
We’ve revamped our QC Micro Summit to expand on our thought leader speaker lineup and scientific program to allow you to keep pace with new industry ... event details »

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