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.
Wednesday, September 23, 2015
The FDA has approved trifluridine/tipiracil for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- , and irinotecan-based chemotherapy, an anti-VEGF biologic product, and ...
read more
Thursday, August 16, 2018
Grifols has received approval from the FDA to relocate existing immunodiagnostic manufacturing operations to a new Consolidated Manufacturing Facility in Emeryville, California.
read more
Wednesday, March 13, 2019
The U.S. Food and Drug Administration (FDA) approved a new generic of Diovan (valsartan).
read more
Friday, November 06, 2015
The U.S. Food and Drug Administration has approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older.
read more
SynCo Bio Partners, a contract manufacturer of biopharmaceuticals, has announced that one of its customers, PaxVax, has received FDA approval for Vaxchora™, a single-dose oral, live attenuated cholera vaccine, indicated for use in adults 18 to 64 ...
read more
Amgen announced the FDA has approved RIABNI, a biosimilar to Rituxan.
read more
Samsung Bioepis announced the FDA has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab).
read more
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 ...
read more
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.
read more
JanOne has received confirmation from the FDA for the IND sponsorship transfer covering its sodium nitrite tablets previously held by Soin Neuroscience.
read more
The FDA awarded 15 new clinical trial research grants totaling more than $22 million to boost development of products for patients with rare diseases.
read more
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.
read more
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.
read more
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 ...
read more
The FDA continues to advance new policies, modernize our programs and advance opportunities for developing more targeted therapies.
read more