Patheon`s Generic Ibuprofen Receives Approval in the U.S.
Patheon' Generic Naproxen Sodium Receives Approval in the U.S.
Neuvivo, a biopharmaceutical company dedicated to ALS treatments, has initiated cGMP manufacturing of NP001 for the treatment of ALS (Lou Gehrig's Disease). The company expects to have product available by the end of the year for clinical use.
Oxcia, a pioneer in oxidative DNA damage and DNA Damage Response (DDR) with a focus on developing new safe treatments for cancer and inflammation, has contracted Patheon for upscaling and production of OXC-101 substance and tablets for the upcoming Phase 2 clinical trials. OXC-101 is Oxcia's first-in-class anticancer drug candidate, currently in phase 1 studies in patients with advanced solid cancers or blood cancers.
Evoke Pharma, a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, has initiated the commercial manufacturing of Gimoti (metoclopramide) nasal spray with its manufacturing partner, Patheon, a division of Thermo Fisher Scientific. Gimoti was approved by the U.S. FDA on June 19, 2020 for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The company plans to launch sales of Gimoti in the fourth quarter 2020 with its partner Eversana.
A small company that is all about the development of dermatology drugs has snagged a new investor and will soon start on a manufacturing facility that will catapult it into the CDMO market. Tergus Pharma says an investment from private equity investor Great Point Partners will allow it to build its first commercial manufacturing facility. The Durham, North Carolina-based company currently provides topical formulation development, in vitro permeating testing, clinical trial materials and other services.
Thermo Fisher Scientific has absorbed HighChem, the Bratislava, Slovakia-based developer and trademark-holder of the Mass Frontier mass spectrometry software used to identify the structures of small molecules.
Cantargia AB and Patheon Biologics B.V. have signed an agreement regarding future production of the antibody CAN04 (nidanilimab). CAN04 is currently in phase IIa clinical development for non-small cell lung cancer and pancreatic cancer. According to the agreement, Cantargia secures additional production capacity for future clinical trials.
Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance
Enforcement Report - Week of March 14, 2018