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.

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.

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.

The Competition and Market’s Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.

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.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.

The agency’s Committee for Medicinal Products for Human Use recommended AstraZeneca’s brodalumab for the treatment of moderate-to-severe plaque psoriasis.