The FDA issued a complete response letter Wednesday to Mylan for its generic version of the Advair Diskus asthma inhaler developed by GlaxoSmithKline. Source: Drug Industry Daily
An FDA advisory committee unanimously voted to recommend approval of Genentech’s new subcutaneous formulation of Rituxan for several blood cancer indications. Source: Drug Industry Daily
HHS Secretary Tom Price told a congressional subcommittee that he and President Trump are developing a plan to reduce drug prices. Source: Drug Industry Daily
FDA Commissioner nominee Scott Gottlieb will recuse himself for one year from decisions relating to more than 20 companies, including large drugmakers, according to his ethics disclosure form. Source: Drug…
An international forum of experts has developed best practices for quality and supply chain security for medical products. Source: Drug Industry Daily
South Korean biosimilars firm Celltrion is challenging the validity of four Genentech patents for combination therapies to treat metastatic breast cancer. Source: Drug Industry Daily
After nearly four years of discussion and expectation, the FDA will begin its inspection reorganization in mid-May. Source: Drug Industry Daily
Sen. Claire McCaskill (D-Mo.) has opened a congressional investigation into the top five manufacturers of opioids, saying the overdose epidemic is a “direct result” of the companies’ sales and marketing strategies…
The FDA cited ZS Pharma over testing and validation issues at its API manufacturing facility in Coppell, Texas. Source: Drug Industry Daily
The FDA placed a Divi’s Laboratories API manufacturing facility in India on an import alert. Source: Drug Industry Daily