Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.

CPhI Pharma Awards seek nominations for excellence in development and manufacturing.

The company expanded its services to include oligonucleotide API development and manufacturing and received approval for its Caponago manufacturing facility.

Evonik will acquire Transferra for an undisclosed amount, and the transaction is scheduled to close at the end of July 2016

A study by MilliporeSigma and the Economist Intelligence Unit reviews growth drivers and approaches to mitigate risk.

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

Califf appointed Richard Pazdur as acting director of the Oncology Center of Excellence under the Cancer Moonshot Initiative.

Antibodies to dengue may either confer protective immunity to the Zika virus or enhance disease severity in secondary, related infections such as Zika.

Mayne entered into an agreement with Teva and Allergan to acquire 37 approved and 5 FDA-filed products.

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

The facility will be built in approximately 18 months using GE Healthcare’s KUBio modular facility solution.

The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.

The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.

ICH detailed the highlights of the council’s June 2016 meeting.

The cell lines have the potential to provide new medical applications for patients suffering from Alzheimer’s disease, Parkinson’s disease, spinal cord injury, diabetes, and muscular dystrophy.

Catalent’s FastChain service is a continuous GMP approach to clinical supply management that decouples primary packaging from secondary packaging, and enables the final assembly, labeling, and distribution of clinical supplies on a regional basis.

A new facility in Marlborough, MA, will house laboratories to support GE Healthcare Life Sciences’ biomanufacturing and development operations.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

ETHOCEL HP is a solvent free advanced productivity technology for barrier membrane coating.

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.

The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.