Pharmaceutical Technology Editors

Takeda will build a new production facility at its existing Grange Castle site in Ireland.

Acasti Pharma and CDMO CordenPharma designed and implemented a continuous process for purifying raw krill oil for production of omega-3 phospholipid.

The company will be acquired for $21.75 per share in cash.

The company announced that it is fully compliant with the 2017–2023 serialization and aggregation requirements.

AAPS elections for Executive Council will be held in June/July 2017; results announced in August.

The new technical services laboratory and conference facility in Noida, India will support continuing industry growth as well as provide local assistance to customers in the region.

Cambrex announces expansions of its North Carolina API pilot plant and Kalskoga, Sweden large-scale manufacturing facility.

Increased capacity at PPD’s Richmond, VA laboratory are designed to support customers’ vaccine development programs.

Expanded storage capacity at the SGS laboratory in Mississauga, Canada increases stability testing capabilities.

The new UPS facility in Columbia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.

The companies expanded their collaboration to evaluate Opdivo and Adcetris in a Phase III trial as a treatment for relapsed/refractory or transplant-ineligible advanced classical Hodgkin lymphoma.

The company recalled the tablets due to a packaging error.

The agency published an action plan to nurture innovation and drug development by SMEs.

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.

The state is alleging that misleading marketing practices contributed to the opioid epidemic in Ohio.

The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The company entered two separate collaborations with Advaxis and Array Biopharma involving its PD-1 immune checkpoint inhibitor Opdivo.

The company entered a collaboration with Protagonist to develop, manufacture, and commercialize PTG-200.

The company was cited for cGMP violations at its Irvine, California facility.

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.

This marks the first FDA approval of a treatment based on a specific biomarker.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

In Lazard's Global Healthcare Leaders 2017 survey, most respondents said pricing and reimbursement were the most significant challenge, but nearly half of the pharma executives who responded see value-based pricing as having the greatest impact on the business, potentially even more than scientific breakthroughs.

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

FDA cited the facility for violations of quality management and data integrity CGMPs.

FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.