Merck & Co. is building a new biomanufacturing facility in Dublin, Ireland. This follows a May 2017 announcement by the company of plans to invest EUR 280 million ($350 million) at two of its Irish manufacturing sites in Brinny, County Cork and Carlow, Ireland. Read More

Teva is facing possible delays for its migraine drug candidate, fremanezumab, following a Warning Letter issued by the FDA to Celltrion, an Incheon, South Korea-based life-sciences company, which is manufacturing the active pharmaceutical ingredient. Read More

Novartis is planning 65 staff reductions at its oral solid-dosage manufacturing facility in Broomfield, Colorado. In October 2017, Novartis announced plans to close the facility. Read More

AstraZeneca has resolved issues at its manufacturing facility in Coppell, Texas for its investigational drug, ZS-9 (sodium zirconium cyclosilicate), a drug for treating hyperkalemia (high potassium levels in the blood serum), which the company gained in its $2.7-billion acquisition of ZS Pharma. Read More

Celgene has completed the first phase for a 135,000-square-foot new immunotherapy manufacturing center at its Summit West campus in New Jersey that will be used for the potential commercial launch of a chimeric antigen receptor (CAR-T) therapy the company is developing with bluebird bio, a clinical-stage gene-therapy company. Read More

Bristol-Myers Squibb (BMS) and Nektar Therapeutics, a biopharmaceutical company, have partnered to develop and commercialize Nektar’s lead immuno-oncology drug candidate in combination with BMS' immuno-oncology drugs, Opdivo (nivolumab) and Opdivo plus BMS’ Yervoy (ipilimuma), in a deal worth up to $3.63 billion. Read More

Seattle Genetics, a biopharmaceutical company, and Pieris Pharmaceuticals, a clinical-stage biopharmaceutical company, have partnered to develop multiple targeted bispecific immuno-oncology treatments for solid tumors and blood cancers in a deal worth up to $1.2 billion. Read More

The FDA has approved a generic version of Teva’s Copaxone (glatiramer acetate injection), a drug to treat multiple sclerosis, from Sandoz, Novartis’ generics arm, and Momenta Pharmaceuticals. Copaxone had 2017 sales of $3.8 billion. Read More

The FDA has issued a Warning Letter to Bayer for cGMP violations for finished products at its plant in Leverkusen, Germany. The agency cited the company for several violations, including for failing to establish and follow adequate written procedures for cleaning and maintenance of equipment and adequately investigating container-closure defects and bag-integrity issues. Read More

The White House's Council of Economic Advisers released a report that outlines policy options to address drug pricing while promoting innovation. It offers proposed changes to Medicare and Medicaid and expansion of the FDA’s expedited review criteria and tools for more efficient reviews. Read More