Predicted areas of growth include flow chemistry, fermentation, repatriation of overseas funds, oncology, and API/product integration, but the rate of change is unclear.

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.

Fluence Analytics’ Argen is a protein and polymer stability monitoring product that uses continuous light scattering measurements to produce an information stream.

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.

Investments include the installation of development and analytical equipment to support the development of highly potent APIs as well as a new 2800-liter hydrogenator and 1500-mm diameter centrifuge for increased flexibility and capacity within the manufacturing plant.

The collaboration will focus on developing a novel and differentiated challenge model for respiratory syncytial virus.

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

CordenPharma will integrate the Hospira Boulder API manufacturing facility into the CordenPharma Colorado network for highly potent and oncology APIs.

Xellia Pharmaceuticals invests US$25 million in its Copenhagen, Denmark site to expand sterile manufacturing of products for treating antimicrobial resistant infections.

Gelest, a manufacturer and provider of silane, silicone, and metal-organic compounds, released a range of dual-function poly(ethylene glycol) (PEG) reagents that enable new approaches to PEGylation for bioconjugates.

The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.

Europe updates the guideline on excipients information in labeling and packaging.

The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.

The company is considering options for a full or partial separation of its Consumer Healthcare business, either through a spin-off, sale, or other transaction.

FDA published guidance on the format and content of REMS documents.

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Cytel, a biometrics CRO and clinical trial software provider, announced that it will be adding a new location for clinical development in Basel, Switzerland.

FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.

Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.

The collaboration aims to help raise funds, awareness, and engagement from pharma community for the charity’s lifesaving work in crises across the globe. 

Aptar Pharma will be a main exhibitor at CPhI Worldwide 2017 and will deliver three briefings on company drug-delivery developments.

Genentech, AmerisourceBergen, and McKesson are providing pharma user requirements for a new project that will evaluate blockchain‘s potential in meeting requirements of the Drug Supply Chain Security Act, and preventing pharmaceutical counterfeiting.

Lonza has announced plans to acquire a clinical-stage mammalian manufacturing facility in the United States from Shire.