IPP Bureau
US FDA to review Amylyx new drug application for AMX0035
By IPP Bureau - February 19, 2022
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
Arrowhead Pharmaceuticals initiates study of ARO-C3
By IPP Bureau - February 19, 2022
AROC3-1001 is a phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3
Abbott recalls powder formula manufactured at Sturgis, Mich., plant
By IPP Bureau - February 19, 2022
Recall does not include any metabolic deficiency nutrition formulas
ValGenesis selected for validating French pharma firm
By IPP Bureau - February 18, 2022
With ValGenesis VLMS, change control driven validation activities are reduced from weeks to mere hours, and the company gains faster access to detailed metrics that help reduce costs and cycle time
USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
By IPP Bureau - February 18, 2022
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
USFDA clears Kairos Pharma’s IND to treat prostrate cancer
By IPP Bureau - February 18, 2022
Phase 2 clinical trial to begin in 2022 with participation by Cedars Sinai Medical Center, University of Utah, and City of Hope
ITM receives investment of EUR 25 mn from Grand Pharma
By IPP Bureau - February 18, 2022
Equity investment follows recent EUR 520 m licensing agreement providing Grand Pharma (GP) access to three of ITM’s targeted radionuclide therapeutic and diagnostic candidates for Greater China
Interactive App from rXperius to provide pharma industry with patient insights
By IPP Bureau - February 18, 2022
The insights collected by the app will support the pharmaceutical industry’s efforts to further improve patients’ lives by providing actionable data on patients’ individual experiences
Top five pharma looks to LifeSphere IDMP for regulatory readiness
By IPP Bureau - February 18, 2022
ArisGlobal's industry-leading regulatory software chosen by top pharmaceutical company for IDMP preparation and global readiness
Modis and ValGenesis partner to bring Best-in-Class validation processes to Italian pharma
By IPP Bureau - February 18, 2022
The partnership will help digitize and automate existing tasks traditionally managed on paper, significantly reducing costs and lead times while increasing compliance
Health Canada authorizes Novavax Covid-19 vaccine
By IPP Bureau - February 18, 2022
Nuvaxovid is the first protein-based Covid-19 vaccine authorized for use in Canada
Sandoz launches generic lenalidomide in 19 countries across Europe
By IPP Bureau - February 18, 2022
Lenalidomide Sandoz is indicated for use in several critical haematology-oncology conditions, per latest ESMO guidelines
Quotient Sciences integrates drug substance into Translational Pharmaceutics Platform
By IPP Bureau - February 18, 2022
The newly enhanced drug development platform will help empower innovators with the fastest development timelines
Ribon Therapeutics appoints Prakash Raman as President and CEO
By IPP Bureau - February 18, 2022
Dr. Raman has succeeded Victoria Richon
Evonik invests in start-up to improve patient recovery after open-chest surgery
By IPP Bureau - February 18, 2022
Evonik invests in start-up to improve patient recovery after open-chest surgery
