IPP Bureau
Lilly's phase 2 retatrutide results show the investigational molecule achieved up to 17.5% mean weight reduction
By IPP Bureau - June 28, 2023
Lilly to further investigate retatrutide for the treatment of obesity in the TRIUMPH phase 3 clinical program
GSK receives USFDA Fast Track designation for investigational vaccine against gonorrhoea
By IPP Bureau - June 28, 2023
Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing
Lonza collaborates with Vertex on cell, gene technologies manufacturing
By IPP Bureau - June 28, 2023
Under the terms of the collaboration, Vertex and Lonza will partner in the process development and scale-up for the manufacturing of the product portfolio and co-invest to build a dedicated new facility in Portsmouth, New Hampshire (US)
Wacker Biotech partners with Caeregen Therapeutics on regenerative treatment for vision loss
By IPP Bureau - June 28, 2023
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
Biotium introduces novel antibody labeling Kits for efficient labeling of IgM antibodies
By IPP Bureau - June 27, 2023
Mix-n-Stain CF Dye IgM Antibody Labeling Kits address longstanding challenges for labeling IgM antibodies by offering efficient and convenient conjugation with bright CF Dyes
Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
By IPP Bureau - June 27, 2023
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
USFDA approves Pfizer’s Litfulo for adults and adolescents with severe alopecia areata
By IPP Bureau - June 27, 2023
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
Moderna files for FDA authorization of its Covid-19 Vaccine
By IPP Bureau - June 27, 2023
Supply readiness follows months of manufacturing to ensure timely and ample supply
Ashland announces Polyplasdone Plus multifunctional disintegrant for improved pharmaceutical process
By IPP Bureau - June 26, 2023
This innovative product eliminates two manufacturing steps and simplifies equipment setup
Aurobindo's subsidiary to withdraw application for EU marketing authorization of two biosimilars
By IPP Bureau - June 26, 2023
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
Sun Pharma presents data from Phase 1 studies of GL0034
By IPP Bureau - June 26, 2023
GL0034 is a novel, investigational glucagon-like peptide 1 receptor agonist (GLP-1RA) being studied for the treatment of type 2 diabetes and obesity
Carbogen Amcis Manchester bags award for manufacturing performance
By IPP Bureau - June 25, 2023
Carbogen Amcis Manchester won the industry award in recognition of its efficiency improvement program implemented in response to increased demand for its products
Ipca Laboratories receives 8 observations from USFDA
By IPP Bureau - June 24, 2023
The company will submit its comprehensive response on these observations to the USFDA