Cubist Pharmaceuticals is recalling 100 lots of its banner antibiotic Cubicin after problems with a contract manufacturer, its third such issue in 12 months.
GlaxoSmithKline is in the process of reviewing regulatory results from a June inspection that found that 10 areas of its Ste. Foy, Quebec, vaccine manufacturing plant needed improvements. But in the meantime, Health Canada has imposed a condition on the facility's license, requiring notice before Glaxo resumes production of Fluviral and FluLaval Tetra.
Russia is striving to produce domestically 50% of the drugs sold in the country, and, to do so, it's encouraging global manufacturers to buy, build or rent facilities there.
Last month, the FDA chided GlaxoSmithKline over issues at its Canadian flu vaccine plant, home to production of seasonal product FluLaval. Now, it's got another regulator on its case, too: Health Canada wants to see GlaxoSmithKline lay out plans for correcting problems at the facility, and it's giving the company 30 days to do it.
Contract developer AMRI has closed its $110 million acquisition of drug manufacturer Oso Biopharmaceuticals, its second deal this year and one the company believes will help pad its annual revenue.
Contract developer Catalent is planning to open a new facility in Japan as it marks 40 years doing business in the country, looking to expand its scale in R&D and manufacturing.
After an inspection from March 31 to April 9 of this year, the FDA didn't much like what it saw at GlaxoSmithKline's Ste-Foy plant in Quebec, home of the company's FluLaval influenza vaccines. Now, the agency has issued a warning, pointing its finger at the British drugmaker for not doing its part to avoid contamination.
After getting the FDA's OK for cell-culture vaccine Flucelvax back in November 2012, Novartis now has a U.S. facility licensed by the agency to produce it. The drugmaker's Holly Springs, NC, plant is now the country's first pandemic-ready site with the regulator's green light to make cell-culture flu vaccines, it said Monday.
In the midst of an ongoing reorganization, contract developer AMRI has made another buy in manufacturing, signing a deal to scoop up CMO OsoBio for $110 million in cash.
WuXi PharmaTech has increased its manufacturing capabilities in China, bolstering its fastest-growing business as it looks to expand around the globe.