IPP Bureau

Meissa Vaccines enters into CGMP manufacturing agreement for pediatric RSV vaccine candidate for Phase 2 clinical trials
Meissa Vaccines enters into CGMP manufacturing agreement for pediatric RSV vaccine candidate for Phase 2 clinical trials

By IPP Bureau - June 29, 2023

Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials

AstraZeneca announces US$400 million investment in reforestation and biodiversity
AstraZeneca announces US$400 million investment in reforestation and biodiversity

By IPP Bureau - June 28, 2023

New reforestation projects in Brazil, India, Vietnam, Ghana and Rwanda in addition to existing projects including in Australia and Indonesia

Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide shows nearly 19% weight loss in people with obesity
Boehringer Ingelheim and Zealand Pharma Phase II trial with survodutide shows nearly 19% weight loss in people with obesity

By IPP Bureau - June 28, 2023

Survodutide has a novel mechanism of action (agonism of the dual GCG/GLP-1 receptors) that may have direct effects on energy expenditure in the liver in addition to decreasing appetite

Oncodesign Services announce access to ImaginAb’s CD8 ImmunoPET technology
Oncodesign Services announce access to ImaginAb’s CD8 ImmunoPET technology

By IPP Bureau - June 28, 2023

Oncodesign Services and ImaginAb sign a Preclinical License and Supply Agreement

Lilly's phase 2 retatrutide results show the investigational molecule achieved up to 17.5% mean weight reduction
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
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
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
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
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
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
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
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
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
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
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

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