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 regulatory support and DMF file management 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 announced today that it has
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.
Pacific-Link Consulting today announced the establishment of Pacific-Link Consulting KK (PLC-KK), an affiliated kabushiki kaisha based in Tokyo, Japan. The Board of Directors of PLC-KK have appointed Sarina Tanimoto, MD PhD MBA as the Managing Director for the newly formed company in Tokyo. Dr. Tanimoto will manage the Japanese based business and brings more than