Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
Amgen announced the FDA has approved RIABNI, a biosimilar to Rituxan.
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Samsung Bioepis announced the FDA has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab).
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Wednesday, April 16, 2014
Patheon , the pharmaceutical services business owned by DPx Holdings, recently received FDA approval for its Bourgoin, France site to begin manufacturing and selling drugs to the U.S. market. The Bourgoin site specializes in development and ...
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Wednesday, August 05, 2020
Quest announced the FDA has granted EUA for a new laboratory technique that speeds the process of extracting viral RNA from specimens to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients.
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JanOne has received confirmation from the FDA for the IND sponsorship transfer covering its sodium nitrite tablets previously held by Soin Neuroscience.
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The FDA awarded 15 new clinical trial research grants totaling more than $22 million to boost development of products for patients with rare diseases.
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The FDA has awarded a cooperative agreement grant to the NABP to establish an information-sharing system for drug compounding activities that are primarily overseen by states.
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Wednesday, September 23, 2015
The FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels.
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Tuesday, February 11, 2025
bioMérieux announced that its BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid has obtained clearance from the U.S. Food and Drug Administration (FDA). This midplex molecular panel tests for 11 of the most common bacteria, viruses, and parasites ...
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The FDA continues to advance new policies, modernize our programs and advance opportunities for developing more targeted therapies.
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Wednesday, March 06, 2019
It is hard for me to write this note to share with you the news that I’ll be leaving my job as the Commissioner of Food and Drugs in the next month.
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As part of its ongoing implementation of the Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan, the U.S. Food and Drug Administration is announcing several actions to protect public health related ...
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In response to scammers on the internet selling unproven medical products, the FDA has taken a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19.
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Friday, February 28, 2020
The FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.
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Eagle Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has denied Eagle’s request for seven years of orphan drug exclusivity in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid...
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