News

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.

A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.

FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.

New offering from Catalent targets integrated development and manufacturing of biologic drugs.

The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.

Researchers at the University of Sheffield, Sheffield, UK, have discovered and developed a new compound that can kill antibiotic-resistant bacteria, including Escherichia coli.

By connecting manufacturing processes and logistics technology, GE Healthcare and World Courier look to accelerate the development of advanced therapies.

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.

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.

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.

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

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

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

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

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

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.

FDA is examining and updating its programs for overseeing global operations and international affairs.

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).

The acquisition will expand Pfizer’s rare disease portfolio with an early pipeline candidate for treating dwarfism.

Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.

A UK-based company, Atelerix, has revealed that it has closed a second round of funding worth £700,000 (US$911,000).