Industry News

NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

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

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.

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

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

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.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

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

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

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.

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

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.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

The FDA commissioner plans to leave the agency in April.

The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.

A project conducted by research institute CEA-Leti led to the development of a new HIV vaccine approach based on engineered lipid nanoparticles.

A multi-partner collaboration has been announced, which will target the acceleration of the development of automated microfluidic systems for rapid and high-throughput gene editing in mammalian cell lines.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.

The agency clarified the process for development programs for regenerative medicine therapies.

Ireland’s National Institute for Bioprocessing Research and Training received funding from the Science Foundation Ireland’s Technology Innovation Development Award program for monoclonal antibody research.