Regulatory
The advisory committee voted 14 to 2 that the benefits of the drug did not outweigh the risks to support approval. The FDA is not obligated to follow the recommendation, but typically do.
The letter outlines multiple failures, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils.
Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, announced that its subsidiary Pergamum AB was granted a patent in the US for the pharmaceutical formulation of the product candidate PXL01.
The ISO 13485 audit is an essential qualification for medical device manufacturers, showing HRA Pharma’s commitment to the highest quality standard.
Second Orphan Drug Designation granted by the European Commission for leriglitazone, in addition to X-linked adrenoleukodystrophy (X-ALD)
In its announcement, Solid Biosciences said a patient in its second cohort who was dosed in October experienced a serious adverse event that was deemed related to the drug.
In Phase 2b development for the treatment of life-threatening fungal infections
Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration has approved QLETLI® for all eligible indications of the reference product, Humira®, in China.
Bridge Therapeutics Inc. announced that it has received feedback from the Food and Drug Administration from a Pre-Investigational New Drug meeting for the development of BT-219, a therapy to treat Opioid Dependence.
Reston Hospital Center Nationally Recognized With An ‘A’ Hospital Safety Grade by The Leapfrog Group
Reston Hospital Center was awarded an ‘A’ Leapfrog Hospital Safety Grade for fall 2019, a national distinction recognizing Reston’s achievements in protecting patients from harm and providing safer health care..
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