News

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 author shares his opinion on the challenges presented by the Internet of Things and what companies need to consider when choosing suitable architectures to manage serialization data.

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 impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

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.

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

New reports indicate that drug prices are slowing compared to other healthcare costs.

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

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.

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.