Pharmaceutical Technology Editors

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.

The LenS3 Multi-Angle Light Scattering (MALS) detector, presented at Pittcon 2019 in Philadelphia, PA, uses a new approach for measuring molecular weight and radius of gyration of synthetic polymers, polysaccharides, proteins, and biopolymers.

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

EMA has issued advice to healthcare professionals and patients on the potential increased risk of blood clots in the lungs and death with higher than recommended doses of Xeljanz (tofacitinib) in the treatment of rheumatoid arthritis (RA).

The organizers of Pharmapack Europe have revealed their prediction that the drug delivery and healthcare packaging industry will experience significant growth during 2019.

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

Microsaic Systems showcased its new MiD ProteinID point-of-need mass spectrometer at Pittcon in Philadelphia, PA, from March 18–21, 2019.

Sartorius introduced the Cubis II portfolio of laboratory balances at Pittcon 2019 in Philaphelia, PA.

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.

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

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

Catalent announces investment for its Zydis ODT technology, offering increased drug load and taste-masking capabilities.

The company is recalling Levoleucovorin Injection, 250 mg/25 mL because of copper salts found during stability testing.

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

The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.

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

The expansion includes a new R&D laboratory and the installation of a 12,000-liter reactor at one of the company’s manufacturing facilities on its Paullo site in Milan, Italy.

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.

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.

A new survey, commissioned by the Royal Society of Chemistry, has highlighted the level of concern within the UK’s chemistry sector surrounding the potential ‘no-deal’ Brexit outcome.

REPROCELL Europe has announced a strategic partnership with Medicines Discovery Catapult, as part of the virtual R&D platform that is aimed at supporting drug development.

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.

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.