The FDA has accepted from Sandoz, the generics arm of Novartis, a biologics license application for a biosimilar to AbbVie’s Humira (adalimumab), which had 2016 revenues of $16.08 billion. Read More

FDA Commissioner Scott Gottlieb has responded to a US Government Accountability Office report regarding the FDA’s development of a better approach for the review and approval process for complex generic drugs. Read More

Eisai has completed construction of a new oral solid-dosage production facility   and an administration building in Suzhou, China. The facility will have double the capacity of an existing plant and will be used to serve the domestic market in China. Read More

Xbrane Biopharma, a Swedish biopharmaceutical company, has signed a non-binding letter of intent with CR Pharma, a Chinese pharmaceutical company, for a biosimilar of ranibizumab, the active ingredient in Roche’s Lucentis, an eye-care drug, which had 2016 sales of $1.8 billion. Read More

FDA Commissioner Scott Gottlieb has issued an update on IV fluid shortages in Puerto Rico following Hurricanes Irma and Maria. The agency is working with manufacturers to ensure that their facilities in Puerto Rico can operate at full capacity and is also working with manufacturers to import product into the US from their foreign facilities. Read More

The US House Energy & Commerce Committee has offered recommendations to improve the oversight and implementation of the 340B Drug Discount Program, a US government program that requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations and covered entities at reduced prices. Read Mo re

The UK Medicines and Healthcare products Regulatory Agency has issued an update for pharmaceutical companies on scenarios regarding pharmaceutical regulation dependent on the implementation plan of the UK in exiting the European Union (i.e., Brexit). Read More

Asahi Glass Company (AGC) Bioscience, part of Asahi Glass Company, a Tokyo-based glass and chemical producer, Biomeva GmbH, a German contract manufacturing organization, and CMC Biologics, a US-based contract biologics manufacturer, have launched as a newly branded company. AGC Biologics had earlier acquired the companies. Read More

FDA Commissioner Scott Gottlieb has outlined steps to enhance transparency of clinical trial information to support scientific inquiry related to new drugs. Read More