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.
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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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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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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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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Samsung Bioepis announced the FDA has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab).
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Amgen announced the FDA has approved RIABNI, a biosimilar to Rituxan.
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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 ...
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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.
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Wednesday, March 13, 2019
The U.S. Food and Drug Administration (FDA) approved a new generic of Diovan (valsartan).
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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.
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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 ...
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Janssen Pharmaceuticals has announced that the FDA approved under priority review the New Drug Application (NDA) for the three-month long-acting atypical antipsychotic INVEGA TRINZA™.
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Wednesday, April 06, 2016
The U.S. Food and Drug Administration has approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
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Wednesday, February 17, 2016
Impax Laboratories has announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine ...
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Thursday, December 17, 2020
GBT has received FDA approval for the commercial sale of the Optiray® Imaging Bulk Package in the United States.
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