Pharmaceutical Technology Editors

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.

The India Expo Mart in Delhi will host CPhI and P-MEC India with expected attendance of 50,000.

Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.

MilliporeSigma targets emerging biotechs with US development center and global grants.

A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.

The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.

The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.