IPP Bureau

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

Industry needs to establish a self-regulatory body to maintain the quality of the pharma products, says Dr  Mandaviya
Industry needs to establish a self-regulatory body to maintain the quality of the pharma products, says Dr Mandaviya

By IPP Bureau - June 25, 2023

Carbogen Amcis Manchester bags award for  manufacturing performance
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

Natural Capsules announces strategic investment by Somerset Indus Capital Partners
Natural Capsules announces strategic investment by Somerset Indus Capital Partners

By IPP Bureau - June 24, 2023

Ipca Laboratories receives 8 observations from USFDA
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

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