PLC’s clinical and regulatory support, including a successful FDA Fast Track designation status for naloxone nasal spray for Adapt Pharmaceuticals resulted in NARCAN®’s approval by the FDA. NARCAN is a needle-free, intranasal spray that can be used to treat opioid drug overdose. NARCAN® (naloxone hydrochloride) Nasal Spray approved by U.S. food and drug administration November
Pacific Link Consulting’s work managing DMF files, as well as regulatory and clinical support culminated in Aegis being awarded the US Patent for the formula of delivery method of their Intravail® formulation. Aegis is Awarded US Patent for Formulation and Non-invasive Delivery of Peptide Drugs SAN DIEGO, CA August 15, 2018/NASDAQ — Aegis Therapeutics LLC
Pacific Link Consulting is proud to have supported Concentric Analgesics Breakthrough Therapy designation for CA-008, a post-surgical non-opioid pain management therapeutic option . PLC compiled and filed the request with the FDA for Fast track approval. FDA Grants Breakthrough Therapy Designation for Concentric Analgesics’ CA-008 in Post-Surgical Pain September 11, 2018 Concentric Analgesics, Inc.,
The Pacific Link Consulting Team has a combined total of 50 + years of experience in the Regulatory Services field, Clinical Trial planning and execution, tracking and filing as well as robust experience developing new products for the US, European and Japanese markets. Clinical Trials Regulatory Services Product Development
PLC, and our London based Partner Sirius Regulatory Consulting, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Jennerex’s product JX-594 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. JX-594 is a novel Oncolytic Virus based on genetic modifications to a Vaccinia virus strain.