Pharmaceutical Technology Editors

A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.

Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

The International Society for Pharmaceutical Engineering (ISPE) launched its philanthropic division, the ISPE Foundation, to support industry demands.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The approval is intended to increase patient access to treatment for opioid addiction.

The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.

The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.

The extension provides four additional process development laboratories at its Nottingham site to improve output and efficiency in drug development and clinical trial manufacturing operations.

WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.

Johnson & Johnson has accepted an offer from Platinum Equity to acquire diabetes solutions business LifeScan for $2.1 billion.

The acquisition expands Micromeritics’ portfolio of products and solutions.

Intelligent manufacturing and environmental policies are key trends at P-MEC 2018.

Researchers at the National Cancer Institute have developed a new approach to immunotherapy that led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments.

The new industry-led Medicines Manufacturing Innovation Center (MMIC) will offer a unique service to develop and implement novel manufacturing techniques.

Microbiologists from the University of Connecticut have pinpointed exterior proteins on syphilis-causing bacteria that could serve as vaccine targets for syphilis.

Recipharm adds inhalation drug manufacturing capacity with the acquisition of Sanofi’s Holmes Chapel, UK site.

FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.

Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.

The companies will partner in research for HIV and hepatitis B immunotherapies, and Hookipa will manufacture arenavirus-based vectors for clinical development by Gilead.

WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.

Alexion Pharmaceuticals and Complement Pharma will partner to develop a preclinical C6 complement inhibitor to treat neurodegenerative disorders.

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.