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GPhA Wednesday threw its weight behind Sandoz in closely watched litigation between Amgen and the French drugmaker, saying the U.S. district court in northern California was correct in denying Amgen’s request for a preliminary injunction to keep Sandoz’ biosimilar of Neupogen off the market. Read More
Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients. Read More
The World Health Organization has launched VigiAccess, a database that allows users to view information on suspected adverse drug reactions collected by national drug authorities in more than 110 countries and spanning more than 100,000 products. Read More
In response to overwhelming requests from industry, the FDA is extending to June 8 the comment period on its draft rule overhauling the ANDA and 505(b)(2) approval processes. Read More
Boehringer Ingelheim should see an FDA decision on its idarucizumab blood-thinning antidote by October, following receipt of priority review late this week. Read More
ISPE’s quality metrics team has narrowed from 16 to five the number of metrics it will ask drugmakers to collect data on during phase two of a pilot program aimed at helping the FDA boost quality compliance. Read More
The Medicare program would have saved $251 million on DME infusion drugs over an 18-month period if the Centers for Medicare & Medicaid Services had stopped paying wholesale prices set more than a decade ago, the HHS Office of Inspector General says. Read More
The FDA plans to discontinue accepting paper submissions from drugmakers submitting promotional materials for prescription drugs and offers guidance on how to submit such information using the electronic common technical document. Read More
Israeli pharma giant Teva is offering $43 billion to acquire rival generics maker Mylan, following weeks of widespread speculation about a possible deal, but the deal may not go down easy. Read More