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Fresenius warned over plant violations; US FDA to review Sun Pharma's Seciera

Top news

* The U.S. Food and Drug Administration warned Fresenius SE & Co. KGaA on violations of drug manufacturing regulations at its manufacturing plant in West Bengal, India. The warning came after the facility aborted 248 drug quality tests.

* Sun Pharmaceutical Industries Ltd. said the U.S. FDA accepted its new drug application for Seciera, a treatment for dry eye disease. Once approved, Sun Pharma plans to commercialize Seciera in the U.S. through its unit Sun Ophthalmics Inc.

Drug and product pipeline

* The China Food and Drug Administration granted priority review and approval status to Eisai Co. Ltd.'s Lenvima for treating hepatocellular carcinoma, a type of liver cancer. The treatment is approved for refractory thyroid cancer in over 50 countries.

Operational activity

* The U.K. is setting up the Future Vaccine Manufacturing Hub, a £10 million vaccine research network that aims to help poor countries improve vaccine manufacturing, the Financial Times reports.

* Shire plc filed its first submission for the company's new plasma manufacturing facility in Covington, Ga., with the U.S. FDA. The facility is expected to add approximately 30% capacity to the company's internal network once fully operational. Commercial production is expected to begin in 2018.

Other features

* Spinal cord implants are emerging as replacements for opioids for people suffering from debilitating nerve pain, Bloomberg Technology reports.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng was up 0.07% to 29,597.66. The Nikkei 225 rose 0.08% to 22,911.21.

In Europe as of midday, the FTSE 100 was up 0.14% to 7,603.56, while the Euronext 100 was down 0.13% to 1,039.67.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.