BioPharm International Editors

The companies will collaborate to produce and improve the recombinant properties of Aethlon’s Hemopurifier blood purification device.

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

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.

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

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.

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.

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

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.

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.

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.

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.

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

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

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.

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.