BioPharm International Editors

Waters debuted a range of new TA Instruments innovations and the BioAccord System at Pittcon 2019 in Philadelphia, PA, on March 17–21, 2019.

Katalyst D2D from ACD/Labs enables the design, planning, execution, and analysis of high throughput (HT) experiments. The web-based application was introduced at Pittcon 2019 in Philadelphia, PA.

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.

A $1.7-billion acquisition CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.

PDC*line Pharma has entered into a licensing agreement with LG Chem to develop a lung cancer vaccine in Asia.

Cell Mogrify (Mogrify), has been granted funding by the UK’s innovation agency, Innovate UK, to accelerate regenerative cell therapies.

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.

Bruker highlighted new analytical systems for several industry applications, including pharma, materials science, and clinical/preclinical research.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

Alcami Biologics formed to meet market demands for biological drug development services.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.

A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.

Findings from the Los Angeles Biomedical Research Institute could enable a new generation of anti-infectives.

Richard Francis will step down as CEO of Sandoz, effective March 31, 2019.

The companies announced a collaboration to jointly discover and develop treatments to address unmet medical needs in a specific neurological disease.

The company received $4.8 million from the Bill & Melinda Gates Foundation to accelerate global health research in the development of vaccines and antibody-based treatments for infectious diseases.

The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.

Brexit update: The UK government has rejected the withdrawal deal again and now faces further uncertainty, despite rejections of a 'no-deal' scenario by ministers, as well as a high probability of Brexit delay.

Stream Bio entered into a new agreement with DBA Italia to launch Stream Bio’s nanotech-based bioimaging probes in Italy.

FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.

The collaboration’s enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.

Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.

The companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of €1.5 million, which will be used to develop a new class of antibiotics to tackle AMR.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.