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, February 03, 2016
Dr. Reddy's Laboratories has announced that the U.S. Food and Drug Administration (FDA) has approved ZEMBRACE™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with ...
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Friday, November 20, 2015
The U.S. Food and Drug Administration has approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose.
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Tuesday, October 06, 2020
Ajinomoto Bio-Pharma Services announced the FDA has approved the first commercial drug manufactured using the company's AJIPHASE production process.
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Wednesday, April 08, 2020
The FDA approved the first generic of Proventil HFA Metered Dose Inhaler, 90 mcg/Inhalation, for treatment or prevention of bronchospasm.
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Wednesday, August 12, 2020
The FDA approved the first liquid biopsy companion diagnostic that also uses NGS technology to identify patients with specific types of mutations of the EGFR gene.
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Wednesday, August 19, 2015
The FDA has approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
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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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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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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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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, 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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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, March 13, 2019
The U.S. Food and Drug Administration (FDA) approved a new generic of Diovan (valsartan).
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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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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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