Pharmaceutical Technology Editors

A new partnership is aiming to advance the use of sublingual delivery technology for challenging drugs.

The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

Cegedim, has announced that it is collaborating with Sanofi to deliver real-world data for the improvement of health within Europe.

Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.

Medherant has announced that it is the recipient of a new £2-million (US$2.5-million) investment from Mercia Technologies.

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

The expansion will increase the company’s single-use capacity to meet growing demand.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.

AbbVie grants Boehringer Ingelheim a non-exclusive license to its intellectual property for Humira (adalimumab) in the United States.

Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

The agency is reviewing Xeljanz (tofacitinib) because of the risk of blood clots in the lungs.

WHP has been awarded with the design contract for the United Kingdom’s first dedicated vaccines manufacturing innovation center (VMIC).

A “Darwinian” drug discovery program aimed at tackling cancer’s ability to develop drug resistance will launch in a new center based in London, United Kingdom.

The acquisition of GlaxoSmithKline’s manufacturing site in Cork, Ireland, will expand Thermo Fisher Scientific’s global footprint for complex API manufacturing.

A CPhI Middle East & Africa (MEA) expert has forecasted a boom in manufacturing in the region and has expectations that within five years some of the industry will be acting as contract manufacturers for the European market.

The Association of the British Pharmaceutical Industry has issued a response to the recently aired BBC Radio 4 investigation program on opioids.

Locate Bio has been granted additional investment to the tune of £2 million (US$2.6 million) for the expansion of its cell and gene therapy pipeline.

The European Medicines Agency has issued a vacancy notice for the position of executive director.

The partnership will focus on the commercialization of inducible promoters to improve biomanufacturing.

StarTab from Colorcon was designed to ensure functionality and stability for direct compression tableting.

The company is recalling the lots because of possible peanut flour contamination.

GE Healthcare launches Chronicle GMP-compliant automation software for cell therapy manufacturing.

The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.

The agency is warning these manufacturers that they are putting consumers at risk with substandard manufacturing practices.

The new 40,000-ft2 facility will support Bayer's growing biologics portfolio in oncology, cardiology, and additional therapeutic areas.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).