Pharmaceutical Technology Editors

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.

Proceeds from the sale will be used to repay the company’s term loan debt under its Senior Secured Credit Facility.

Germany-based Grünenthal will gain rights to market and sell Zomig (zolmitriptan) outside of Japan. 

The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.

The company released an interim analysis from its JULIET study with CTL019.

The new training center will feature technologies that boost biomanufacturing.

The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.

Lubrizol Invests $60 Million to Expand Particle Sciences and Other Facilities in 2017.

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.