Pharmaceutical Technology Editors

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.

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.

A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.

Swedish based company, SenzaGen, has signed a license agreement with contract research organization (CRO) MB Research Labs.

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.

The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.

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.

The CHMP has recommended for authorization a new medicine for patients aged 16 years and older with phenylketonuria-Palynziq (pegvaliase).

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.

Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.