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Drug manufacturer planned to shred cGMP documents ahead of inspection
europeanpharmaceuticalreview
July 22, 2019
An Indian pharmaceutical company was planning to shred quality control records ahead of an FDA inspection, found officials.
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Sickle cell drug wins Priority Review by the FDA
europeanpharmaceuticalreview
July 22, 2019
The US Food and Drug Administration (FDA) has given an investigational sickle cell medicine, crizanlizumab (SEG101), Priority Review.
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Merck’s Recarbrio gets FDA approval for treatment of infections
pharmaceutical-technology
July 19, 2019
The US Food and Drug Administration (FDA) has approved Merck’s Recarbrio injection for the treatment of complicated urinary tract infections (cUTI) and intra-abdominal infections (cIAI).
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Another Study Casts Doubt on Safety of Herbal Drug Kratom
drugs
July 19, 2019
The herbal supplement kratom regularly causes serious side effects and doesn't appear safe for use, a new study argues.
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U.S. Drug OD Deaths Fall for First Time in Three Decades
drugs
July 18, 2019
For the first time in three decades, drug overdose deaths in the United States fell last year, preliminary federal government data suggest.
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Top five generic drug makers
europeanpharmaceuticalreview
July 17, 2019
Top five generic drug makers.
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Catalent Breaks Ground in Indiana
contractpharma
July 16, 2019
$112 million drug product manufacturing facility will increase fill/finish capacity by 79,000 sq. ft.
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Amgen wins patent block on Sanofi drug rival
drugs
July 16, 2019
Amgen has successfully blocked the manufacture, sales and marketing of its Sanofi drug rival in Germany.
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FDA grants Orphan Drug Designation to Imfinzi for SCLC
europeanpharmaceuticalreview
July 16, 2019
The FDA has announced Orphan Drug Designation for Imfinzi (durvalumab) to treat small cell lung cancer in combination with other therapies.
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Increase Seen in Foster Care Entries Due to Parental Drug Use
drugs
July 16, 2019
The number of foster care entries attributable to parental drug use increased considerably from 2000 to 2017...