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The FDA is still not convinced that Sprout Pharmaceutical’s libido-enhancing drug for women is safe, particularly when mixed with alcohol, and has asked two of its advisory committees to consider whether alcohol should be contraindicated in the product’s labeling. Read More
Novartis has filed a complaint in federal court alleging Apotex infringed on its patent by seeking to manufacture, market and sell a generic version of cancer drug Zometa. Read More
The UK’s National Institute for Health and Care Excellence confirmed its recommendations for Bayer’s Eylea and Allergan’s Ozurdex for some patients with diabetic macular edema in separate final draft guidances. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said Monday, adding that the current system of different expectations is not sustainable. Read More
The U.S. Supreme Court has turned down a request to overturn an appellate court’s decision that vacated a federal district court’s ruling dismissing a case claiming that Purdue Pharma overstated the potency of its painkiller OxyContin. Read More
The high cost of AstraZeneca’s ovarian cancer treatment Lynparza doesn’t match the uncertainty of its survival benefits, the UK’s healthcare cost agency says. Read More
Upsher-Smith’s Qudexy XR is now available as a first-line monotherapy for children ages two and older who have partial-onset or tonic-clonic seizures. Read More
AstraZeneca and Eli Lilly have agreed to conduct a clinical trial to assess the safety and preliminary efficacy of AZ’s experimental anti-PD-L1 immune checkpoint inhibitor MEDI4736 in combination with Lilly’s Cyramza treatment for patients with advanced solid cancer tumors. Read More