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Pharma Manufacturing

Opportunities in Pharma RFID and Smart Packaging

After two deaths, FDA hits the brakes on leukemia treatment study

The FDA has placed a partial hold on a phase 1 study into the study of a…

India's Glenmark to launch US spin-off

Generic drugmaker Glenmark Pharmaceuticals plans to spin off its…

Biotech CEO takes aim at Pentagon for not funding PTSD drug

The head of a small biotech firm had sharp words for the Pentagon over its…

External Partnerships, Redefined

Why building the right manufacturing partnerships is fundamental to…

Norvartis invests $115M more in biotech AveXis to double manufacturing

The expansion is expected to add 200 jobs in North Carolina, helping the…

FDA issues six observations for Lupin plant

The U.S. FDA has issued six observations after the inspection of Lupin's…

FDA issues first warning letter under DSCA for opioid distribution

McKesson Corp is back in the spotlight for opioid-related violations —…

FDA warns of blood pressure med shortage

FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock released…

Former pharma exec accused of giving a lap dance as part of an opioid kickback scheme

A former sales executive from Insys Therapeutics reportedly once gave a…

Vertex fires COO for "personal behavior"

Vertex fired its chief operating officer/interim chief financial officer…

Puerto Rico Pharma: Battered but Unbroken

One year after Hurricane Maria, Puerto Rico's pharma industry is standing…

Top Pharma Manufacturing Predictions for 2019

From new tech to innovative business models and shifting regulations,…

Top 5 Drugs With the Biggest Growth Potential in 2019

In the coming year, several drugs that treat a range of diseases will far…

Boehringer cuts nearly 300 jobs in France

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Roche R&D exec leaves pharma for biotech, joins Voyager Therapeutics

Voyager Therapeutics appoints Omar Khwaja as its chief medical officer,…

Weighing and Dispensing: Do it Right

The weighroom is the entry point to manufacturing and a transition point…

CAPA and Root Cause Analysis

Recent FDA Warning Letters have cited insufficient corrective and…

Annual Product Reviews: How to Conduct an Effective Annual Product Quality Review

More than just a regulatory requirement, an APR helps the manufacturer to…

USP Updates <61> and <62> for Microbial Testing of Non-Steriles

Significant changes include more clarity on enumberation and specified…

Serialization and the Drug Quality & Security Act

The supply chain for genuine pharmaceuticals has grown longer, and every…