Press Releases

Press Releases

ProQR Therapeutics N.V., a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe orphan diseases such as cystic fibrosis (CF) and Leber's congenital amaurosis Type 10 (LCA10), today announced that it received Fast Track designation from the Food and Drug Administration (FDA)…

Press Releases

Cerulean Pharma Inc., a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Cerulean’s lead nanoparticle-drug conjugate, CRLX101, in combination with paclitaxel, for the treatment of platinum-resistant ovarian carcinoma, fallopian tube or primary peritoneal cancer. “We appreciate the…

Press Releases

Depomed, Inc. announced the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) declined to institute the Inter Partes Review (IPR) petition filed by Rosellini Scientific, LLC with respect to U.S. Patent No. 7,994,364 (the "'364 Patent") with respect to all patent claims subject…

Press Releases

AMAG Pharmaceuticals, Inc. today announced that William Heiden, chief executive officer (CEO), has been named to the Board of Directors of the Pharmaceutical Research and Manufacturers of America (PhRMA). "The focus of our work at AMAG has been, and continues to be, on improving the lives of patients,” said Mr.…

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CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients.  This expands the use of Berinert into all age groups, making it the first and…

Press Releases

The Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the European Medicines Agency (EMA). The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and…

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Synergy Pharmaceuticals Inc. today announced it has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC). Additionally, the company is providing an update on the ongoing irritable bowel syndrome with constipation (IBS-C) program. “We are pleased with…

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Guardant Health, the leader in comprehensive liquid biopsies, announced a strategic collaboration with OncoMed Pharmaceuticals, a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics. Using Guardant Health's digital sequencing technology, the companies have developed a custom blood test that looks for specific biomarkers relevant to OncoMed's ongoing Phase…

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Provectus Biopharmaceuticals, Inc., a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or “The Company”), today announced that it has formed an Australian subsidiary, Provectus Biopharmaceuticals Australia Pty Ltd. In addition, the Company is opening a Sydney office in New South Wales. Peter Culpepper, Interim CEO, stated, “The creation of an…

Press Releases

Yisheng Biopharma Co., Ltd., a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of biological vaccines and pharmaceutical products, and the United States Army Medical Research Institute of Infectious Diseases  ("USAMRIID") today announced preliminary positive animal results of a virus-like particle (VLP)-based vaccine in combination with PIKA adjuvant, …