News

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

Telstar has a dedicated process analytical technology (PAT) corner at its booth to display new developments for pharmaceutical freeze drying systems and aseptic manufacturing processes.

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.

The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.

The technology, known as Verifi, is available with the ChargePoint’s range of valves that ensure safe and contamination-free handling of API and other formulation ingredients.

The tablet tooling manufacturer will showcase its products and services, which include an online training package and a tool management system for proactive monitoring of tooling rotations, inventory, and maintenance.

The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.

InstantGMP INV is a validated software for real-time material tracking and inventory control in biopharmaceutical manufacturing.

Johnson & Johnson’s Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen’s immunotherapy platform.

Takeda expands its global and therapy base with announced acquisition of Shire.

L.B. Bohle’s QbCon 1 laboratory-scale, continuous twin-screw granulator and dryer offers fully continuous drying for R&D in continuous solid-dosage manufacturing.

A new facility will allow Fette Compacting to double its production capacity for tablet presses in Nanjing, China.

Bosch’s Industry 4.0 solutions deliver full transparency for all process and machine data.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.

Herma’s new label removal unit reduces the time for discharging misprinted labels by more than half.

GE Healthcare’s new Sefia S-2000 cell processing system allows operators to conduct multiple cell therapy manufacturing steps with one instrument.

Romaco will display the IHD series for processing hot melt coatings at Achema 2018.

The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.

The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.

As Astellas Pharma winds down its Agensys research operations, the company sells the Santa Monica, CA, facility to Gilead.

The companies plan to advance programs for dementia and other neurological conditions.

Geofrey Wyatt has been named CEO and Clifford Wyatt named president of Wyatt Technology.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.