Pharmaceutical Technology Editors

The Belgian biopharmaceutical company has formed a subsidiary in the United States, and appointed Daniel Schneider as its general manager.

The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

Piramal is investing $55 million into the expansion of its API manufacturing capabilities and capacities across sites in North America and Asia.

Dow’s portfolio of solutions for pharmaceutical applications now includes products from Dow Corning’s silicone technology platform.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.

Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

Coperion K-Tron has added the K3-PH-ML-D4-QT35 design to the company’s K3-PH line of feeders for a variety of continuous processes, and will showcase the feeder at the 2017 ISPE Annual Meeting and Expo.

West will be showcasing its range of packaging components and drug delivery solutions, including NovaPure components, LyoSeal caps, and the SmartDose platform.

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.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

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.