The FDA has asked for more information on the pen injector device used in Sanofi and Zealand Pharma's IGlarLixi combination product for diabetes, and extended its review by three months, hurting its chances to be the first product of its kind on the U.S. market. Read More

Allergan has released a drug shortage notice to the FDA regarding its product Avycaz due to an issue with its API maker. Read More

The FDA has asked for more information from Portola Pharmaceuticals in a Complete Response Letter (CRL) to a BLA for the product AndexXa. Read More

Bayer’s Nexavar cancer drug has been rejected by NICE for the second time due to the high cost of the liver cancer medication. Read More

A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition. Read More

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has effectively banned products from a Pfizer plant in India after a joint inspection by the FDA, MHRA, Australia’s Therapeutic Goods Administration and Health Canada, the first joint investigation by the four agencies. Read More

The FDA awarded Janssen’s esketamine a second breakthrough designation for major depressive disorder with imminent risk of suicide, adding a second potential indication for the investigational compound. Read More

The FDA has released its annual report to Congress on statistics on delays in approval of applications related to citizen petitions and petitions for stays of agency actions for the 2015 fiscal year. Read More